RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) News - April 4, 2017

Positive Results from RepliCel’s RCS-01 Phase I Skin Trial
are the Company’s Most Compelling to Date

Interim trial results lead researchers to conclude that the injection of RCS-01 is not only very safe, but also has the potential to reverse effects of aging skin, representing a natural alternative to existing anti-aging treatments

VANCOUVER, April 4, 2017 /PRNewswire/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the "Company"), is pleased to report statistically and clinically significant positive data from the interim analysis of its phase I study evaluating RCS-01 for the treatment of aging and sun-damaged skin.

The primary objective of this trial was to establish a complete safety profile for intradermal injections of RCS-01 (RepliCel’s type 1 collagen-expressing, hair follicle-derived fibroblasts “NBDS cells”) at six months post-injection. Participants in the Germany-based study did not report any serious adverse events at the interim point of the trial. Researchers also gathered compelling positive proof-of-concept data indicating the product’s potential for skin rejuvenation.

The study was neither powered for, nor was expected to show statistically significant results of efficacy. However, the nearly two-fold increase in gene expression of collagen-related biomarkers in the skin, after a single injection of RCS-01, was so profound with a single RCS-01 injection, that the results are considered statistically significant. The study observed the impact of the injection on ten different biomarkers that, in peer-reviewed medical literature, are highly correlated with skin aging and chronically sun-damaged skin. Notably, gene expression markers, such as tissue inhibitor of metalloproteinases (TIMP), showed significant changes expected to correlate with increased collagen fibers. Increased collagen production, and reduced collagen degradation, is associated with fewer wrinkles and the repair of sun-damaged skin.

“This type of positive effect on TIMP gene expression, which is related to protection against collagen degeneration, is rarely observed. In my experience, after decades of performing these tests, this is an exceptional finding, particularly for a safety trial with a small sample size,” stated Prof. Dr. med Jean Krutmann, Scientific Manager of the IUF Leibniz Research Institute for Environmental Medicine where the study was conducted. “The promising results demonstrate the potential of RCS-01 to promote skin rejuvenation. An increase in collagen markers of this nature would be expected to translate into clinically measurable and aesthetically visible effects.”

Krutmann concluded: “Replication of these results in a larger trial would confirm our view of the product’s potential as a more natural alternative to Botulinum toxins and fillers that only temporarily prevent and reverse the signs of aging.”

“This study not only showed an excellent safety profile, but also provides compelling proof-of-concept that RepliCel’s RCS-01 cells are, by nature, very good collagen producers in the skin,” stated Dr. Rolf Hoffmann, RepliCel’s Chief Medical Officer. “We are highly encouraged by the findings and eager to demonstrate the correlation between the change in these biomarkers and clinically important endpoints such as wrinkle depth, in a larger multi-centre trial studying optimal dose and treatment frequency.”

“As a practicing dermatologist,” Hoffmann continued, “the potential of RCS-01 represents a leap-forward in the way we look at skin anti-aging, especially for the fine wrinkles in UV-damaged skin where we have no long-lasting treatment today. Of importance is the fact that, because RCS-01 is comprised of cells derived from tissue at the back of the patient’s scalp, these cells are not only very good collagen producers, but also UV- protected and therefore more functionally active.”

“In my opinion,” Hoffmann concluded, “this is the first example of a treatment potentially capable of rejuvenating UV-damaged skin.”

“This is the most compelling data we have announced to date,” stated RepliCel CEO and President, R. Lee Buckler. “Longer term, this data is very complementary to our focus on commercializing a next-generation dermal injector and its targeted application not only with RCS-01, but also with other aesthetic products on the market today. We look forward to discussing these findings and the potential of our products with a number of aesthetic-focused institutional investors and major multinational licensing partners who have already expressed interest in our programs.”

About Aging and UV-damaged Skin Markets

Ultra-violet (UV) light exposure from the sun is responsible for up to 80% of visible facial skin aging. According to statistics from the American Society for Plastic Surgeons, $2.5 billion was spent on facial aesthetics in 2013 and this is predicted to grow to over $5.4 billion by 2020. Dermal filler procedures are growing over 15% annually.

About the RCS-01 Study
The clinical trial was a randomized, double-blind, placebo-controlled, single-centre, phase I safety study of intradermal injections of RCS-01 in healthy subjects. The primary endpoint was to assess the local safety profile by recording and evaluating adverse events reported at the treatment evaluation sites. Secondary safety measures related to any reporting of systemic adverse events and assessment of histopathological abnormalities of the treatment sites. Secondary endpoints also included evaluating any changes in expression of numerous genetic markers (using real-time PCR) related to intrinsic skin aging, skin wrinkling and solar degeneration of skin.

After trial inclusion, all participants provided a biopsy from the scalp from which RCS-01 was prepared at a central GMP manufacturing site. Study participants were randomized to one of two treatment subgroups that received intradermal injections of either RCS-01 or placebo. Each participant had four treatment evaluations sites identified on their buttocks, two on each side to allow for a within-subject comparison of single and triple injections of RCS-01 with placebo respectively. Participants in the RCS-01 Subgroup received injections of RCS-01 or placebo or a ‘sham’ injection (a needle penetration without injection of liquid). Participants in the Placebo Subgroup were randomized to receive only injections of placebo or sham injections to compare the systemic safety profile to the RCS Subgroup.

Baseline evaluations of subjects’ overall health and skin condition at treatment sites on their buttocks were performed before receipt of injections at Day 0. In addition to injections delivered at Day 0, the pre-selected treatment evaluation sites received intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four and eight weeks after Day 0 according to a randomization schedule for a total of three injections per treatment site.

All participants returned/will return to the clinic for at least nine visits to monitor safety. Assessment of the local safety profile was performed by the investigator before each injection visit, two to four days after injection, and 12 and 26 weeks after injection. The investigator was asked to examine each treatment site for the presence or absence of local adverse events and grade them with respect to relatedness to treatment, severity and seriousness. Other study assessments included recording of vital signs at each visit and routine laboratory assessments at screening, injection visits and at the Week 26 time point. At the 12-week time point, nine randomly selected participants provided biopsies from all injection sites for gene expression analysis of skin markers related to aging. At Week-26 (cut-off date of the interim analysis), the remaining participants provided biopsies of all injection sites for histopathological analysis.

All reported pre-defined local adverse events related to injection or sham were transient and mainly mild in intensity only. No other related local or systemic adverse events were reported. No clinically relevant abnormal laboratory results or abnormal vital signs were reported up to the cut-off date of this interim analysis. Histopathological assessments of treatment evaluation site biopsies were all judged to be normal by a blinded investigator.

About Prof. Dr. med Jean Krutmann
Prof Dr. med Jean Krutmann is Professor of Dermatology and Environmental Medicine and Director of the IUF Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University Düsseldorf. He is a coordinator of the Leibniz Research Alliance “Healthy Aging” (a strategic alliance of 23 Leibniz institutes). His research is in the field of derma-toxicology and immune-dermatology with special emphasis on environmentally-induced skin diseases and skin aging. Prof. Krutmann is author or co-author of more than 200 papers. He is the recipient of the International Arnold-Rikli-Award, the Albert Fleckenstein Award, the Paul Gerson Unna Award, the Oscar Gans Award, the C.E.R.I.E.S. Research Support Award and the Dermopharmacy Innovation Award. He is a visiting and adjunct professor of dermatology at the Nagoya City University, Japan, Case Western Case Western Reserve University, Cleveland, Ohio and University of Alabama, Birmingham, AL, USA. He is a member of the National Academy of Science of Germany and Xu Guang Qi Lecturer, Shanghai Institute for Biological Sciences (CAS), Shanghai, China.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of three clinical-stage products: RCT-01 for tendon repair, RCS-01 for skin rejuvenation and RCH-01 for hair restoration. RCH-01 is under exclusive license by Shiseido Company for certain Asian countries. All product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.

RepliCel is also developing a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit http://replicel.com/ for additional information.

For more information, please contact:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com


Forward-looking information
Certain statements in this news release are forward-looking statements, which reflect the expectations of management regarding the results of the RCS-01 Phase 1 skin trial. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Forward looking statements in this news release include: statements relating to the anti-aging potential of RCS-01, its ability to promote skin rejuvenation, and its potential as a more natural alternative to Botulinum toxins and fillers; the Company’s expectation that significant changes to gene expression markers are expected to correlate with increased collagen fibers; that increased collagen production and reduced collagen degradation should potentially lead to fewer wrinkles and the repair of sun-damaged skin; that RepliCel’s RCS-01 cells are by nature very good collagen producers in the skin; the potential correlation between changes in biomarkers and clinically important endpoints; that the potential of RCS-01 represents a leap-forward in skin anti-aging; the potential application for other aesthetic products; and the expected timing of return of trial participants for analysis and the process to be undertaken in connection with same. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with future approvals for clinical trials; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties in connection with the outstanding issues alleged by Shiseido in connection with the License and Co-development Agreement; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2015 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE RepliCel Life Sciences Inc.

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Recent RepliCel News:

RepliCel's Successful RCT-01 Tendon Repair Clinical Trial Shows Signs of Healing Chronic Tendon Problems

First-in-human clinical study meets primary endpoint demonstrating product safety and clinical potential for tendon regeneration and healing

VANCOUVER, March 28, 2017 /PRNewswire/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the "Company"), is pleased to report compelling safety and clinical data from its phase 1/2 tendon repair study investigating the use of RepliCel’s type 1 collagen-expressing, hair follicle-derived fibroblasts (RCT-01) as a treatment for Achilles tendinosis.

The clinical trial met its goal of establishing a complete safety profile at 6 months and showed no serious adverse events related to the study treatment or injection procedure.
Additionally, each of the treated participants, all of whom suffered chronic tendon pain and loss of function over an extended period of time with no recovery from standard treatments, showed numerous clinically important improvements by various measures including tendon composition, blood supply, physical function and pain sensation.

“Chronic tendinosis is a state of tendon degeneration that is very difficult to reverse as is borne out by the many therapies and modalities that are used to try and treat it,” stated Dr. Ross Davidson, an orthopedic surgeon, former clinical professor at the Department of Orthopaedics at the University of British Columbia, and past head physician and orthopaedic consultant for the Vancouver Canucks (of the National Hockey League (NHL)).

“This study shows exciting clinical improvements in patients with clinically diagnosed chronic Achilles tendinosis who were unresponsive to standard treatments, and who had suffered for many months (in some cases, years) with frequent pain and loss of function. Not only did the study show several clinically important improvements in pain and function scores, but several ultrasound measures clearly demonstrate a marked improvement in tendon structure; something rarely seen in patients with this condition,” said Davidson.

“With further clinical studies, this new technology could represent a cutting-edge advancement in kick-starting a healing process that results in tendon regeneration. For the first time, we may have a treatment that shows signs of reversing the underlying problem, versus just treating the symptoms. This could be a game-changer in sports medicine,” Dr. Davidson concluded.

The most clinically material improvements observed from the study are summarized as follows:

VISA-A Scale of Achilles Tendon Injury Severity
Participants treated with RCT-01 in the per protocol population who completed the VISA-A evaluation 6 months after receipt of injections showed clinically relevant signals of healing including an overall 15.3% improvement in total score compared to baseline. Two patients showed select measures of near-complete recovery in function (by VISA-A scoring).

VAS Scale of Pain Severity
Four out of five participants treated with RCT-01 who completed questionnaires 6 months after injection showed clinically relevant signals of improvement in pain on loading (running/jumping) based on VAS score. Average improvement in VAS score for the four participants was 62.9% over baseline VAS score.

Three out of five participants treated with RCT-01 who completed questionnaires 6 months after injection showed improvement in pain on palpation based on VAS score. Average improvement in VAS score for the three participants was 55.2% over baseline VAS score.

Two patients showed select measures of near-complete elimination of pain (by VAS scoring).

“This trial was to show the safety of injection of hair follicle-derived non-bulbar dermal sheath cells (NBDS),” stated RepliCel’s Chief Medical Officer, Dr. Rolf Hoffman, “as well as to repeat the landmark trials of our collaborators who injected skin-derived fibroblasts together with PRP (Platelet-rich plasma) in different tendinopathies. We believe the cause of healing (mechanism of action) in those studies was the cellular collagen production and not the PRP which, in our view, has little clinical or commercial potential as a therapeutic product or treatment for tendon repair.”

“I am very pleased that in this trial we see some early signals of regenerative healing in some patients and because of its similar pathogenesis, there is every reason to believe the ability to heal Achilles tendons will extend to numerous applications including repairing the patellar tendon of the knee (jumper's knee), both tendons of elbow (tennis elbow, golfer's elbow), and the rotator cuff,” observed Dr. Hoffmann. “Furthermore,” he concluded, “when we have established that our cell therapy heals chronic tendon injury, it may then be used by physicians for more acute injury with the goal of an approved label for these additional treatments in the future.”

“This is a major step forward in the Company’s development of a series of products which leverage the exciting collagen-producing capacity of these cells,” stated RepliCel CEO, Lee Buckler. “Our management and clinical team are very excited about the data from this trial and the potential for further development and clinical testing of this product to treat patients without good options for the tendon degeneration, pain and loss of function they are experiencing. ”

Buckler concluded: “We have captured the medical and investment communities’ attention and see the results of this much anticipated, proof-of-concept clinical study as an opportunity to advance therapies for patients and incrementally add value for shareholders in the months ahead.”

About Achilles Tendinopathy
Achilles tendinopathy is a condition that causes pain, swelling and stiffness of the Achilles tendon that joins your heel bone to your calf muscles. It is thought to be caused by repeated tiny injuries to the Achilles tendon. These may occur for a number of reasons, including overuse of the tendon; for example, in runners. Treatments range from physiotherapy, to anti-inflammatory medications, to surgery. For many people, symptoms of Achilles tendon injury usually clear within three to six months of starting treatment. However, for some people the injury does not respond to treatment and progresses to chronic tendinosis. There is an estimated incidence rate of 656,211 new cases of mid-portion Achilles tendinopathy each year in North America alone, according to statistics published in the British Journal of Sports Medicine.

About the RCT-01 Tendon Repair Study
The study was designed to demonstrate the safety of a single injection of RepliCel’s RCT-01 into the Achilles tendon. While the study was not designed to be statistically significant for efficacy, multiple measures of efficacy were incorporated to give insights into the product’s potential and to assist in guiding future development decisions. Measures of whether the product may be working included testing and scoring patient pain in various settings, evaluating overall function, blood flow changes in the tendon, and changes in the overall density and composition of the tendon as measured by ultrasound imaging. For further trial details see: https://www.clinicaltrials.gov/ct2/show/NCT02330146.

The first-in-human study involved patients clinically diagnosed with chronic Achilles tendinosis. The primary purpose of this single-centre, phase 1/2 randomized (3:1), double blind, placebo-controlled trial was to assess the safety profile of RCT-01 injections, as compared to placebo injections. The study also measured the potential efficacy and impact injections had on tendon structure and function and the symptoms of Achilles tendinosis. The study was led by principal investigator Dr. Rob Lloyd-Smith, MDCM of the University of British Columbia (UBC) and was conducted at the UBC Sports Medicine Clinic in Vancouver, BC, Canada. Data from such a trial, not designed for statistical significance, often signals clinically significance, which is extremely informative for future product development and clinical trial design. The goal of the study was to establish sufficient evidence of safety to allow the Company to proceed with well-powered phase 2 studies investigating optimal dosing, treatment frequency, effect duration, etc.

As was expected with injecting 1.5mL into the Achilles tendon, all study participants who received injections (less one RCT-01-injected participant) reported at least one adverse event related to treatment regardless of treatment administered (RCT-01 or placebo). The adverse events were either soreness at the injection site or the observation of a partial thickness tear in the tendon post-injection. Most reports of soreness resolved shortly after receiving injections.

About Tendon Treatment Clinical Efficacy Measurements

VISA-A
The VISA-A scale aims to evaluate the clinical severity for patients with chronic Achilles tendinopathy. It is a questionnaire which evaluates symptoms and their effect on physical activity. It can be used to compare different populations with chronic Achilles tendinopathy and facilitate comparisons between studies. It can be used to determine the patient’s clinical severity. The VISA-A represents a clinically validated, reliable and disease-specific questionnaire to measure the condition of the Achilles tendon, but it is not a diagnostic tool. The final version of the questionnaire was named the Victorian Institute of Sport Assessment-Achilles Questionnaire.

VAS
A Visual Analogue Scale (VAS) is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. It is an instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. From the patient’s perspective, this spectrum appears on a continuum, in that their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest. It was to capture this idea of an underlying continuum that the VAS was devised.

About Dr. Ross Davidson
Dr. Davidson is the former Director, Post Graduate Programmes in Sports Medicine at the University of Auckland, and a member of the New Zealand Orthopaedic Association and the Canadian Orthopaedic Association. He is the past president of the National Hockey League Physicians Society, past head physician and orthopaedic consultant for the Vancouver Canucks Hockey Club (NHL), past orthopaedic consultant to the Vancouver Grizzlies Basketball Team (NBA), past orthopaedic consultant to Allan McGavin Sports Medicine Centre, and past orthopaedic consultant to the Canadian Football League Players Association. Dr. Davidson held the position of clinical professor, department of orthopaedics at the University of British Columbia until 2000.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of three clinical-stage products: RCT-01 for tendon repair, RCS-01 for skin rejuvenation and RCH-01 hair restoration. RCH-01 is under exclusive license by Shiseido Company for certain Asian countries

All product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. RepliCel has also developed a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit http://replicel.com/ for additional information.

For more information, please contact:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

Forward-looking information
This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding (i) that RCT-01 has the ability to heal Achilles tendons, (ii) that RCT-01 will extend to numerous applications including repairing the patellar tendon of the knee (jumper’s knee), both tendons of elbow (tennis elbow, golfer’s elbow), and the rotator cuff, (ii) that the results of this clinical study will act as an opportunity to advance therapies for patients and incrementally add value for shareholders over the months ahead.

These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with future approvals for clinical trials; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties in connection with the outstanding issues alleged by Shiseido in connection with the License and Co-development Agreement; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2015 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE RepliCel Life Sciences Inc.

RepliCel's Phase 1 Clinical Trial for Hair Loss Succeeds in Meeting Primary Endpoints

Five-year safety data firmly establishes product safety and confirms ongoing clinical and product development strategy

VANCOUVER, March 14, 2017 /PRNewswire/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the "Company"), a clinical stage regenerative medicine company developing unique biologic products for pattern baldness and thinning hair, aging and sun-damaged skin, and chronic tendon degeneration, today announced the successful completion of its first-in-human clinical study of the Company's autologous cell therapy for the treatment of androgenetic alopecia (pattern baldness).

The Company reports the trial succesfully met its endpoints and sets the stage for next steps in the ongoing research and development of its product, RCH-01, for the treatment of male and female androgenetic alopecia. "As we march toward commercialization of this product based on this first-in-human data, our aim is to revolutionize the way we prevent, treat, and even reverse hair loss," stated RepliCel President and CEO, R. Lee Buckler.

Safety
The five-year trial data set has confirmed the complete safety profile of a high-dose of dermal sheath cup cells (DSCC) for patients with pattern baldness due to androgenetic alopecia.

These DSCC form the basis for the Company's RCH-01 product. The long-term safety of DSCC injections was demonstrated through multiple physician, patient and independent measures of local and systemic tolerance including evaluation of adverse events with respect to causality, incidence, severity and seriousness. No serious adverse events were reported over the entire 60.5-month follow-up period of the trial. Local injection tolerance was confirmed with only a few minor scalp irritations reported around injection sites that resolved quickly soon after injection. Furthermore, histopathological evaluation of injection site biopsies taken six, 12, and 24 months after injection did not reveal any pathology that was suggestive of tumour, granuloma or foreign body formation. An analysis of injection site biopsies taken 60.5 months after injection is currently ongoing with results expected in the next few weeks. Long-term systemic safety of RCH-01 was also confirmed as none of the systemic adverse events reported during the extended safety evaluation were related to treatment.

Indications of Potential Efficacy
The trial was designed to gather data related to the product's potential efficacy through 24 months post-injection, but was not designed for statistical significance related to any efficacy endpoints. The efficacy data collected from all 19 patients, while not statistically significant, provides useful and potentially exciting insights into the product's potential for the treatment of those with androgenetic alopecia.

"We have a much greater understanding and opportunity for further insights from the hair density responses recorded in this first-in-human trial," stated RepliCel President and CEO, R. Lee Buckler. "This data will feedback into our R&D programs and help us develop the best possible product and treatment protocol for men and women suffering from androgenetic alopecia."

The seven top-tier responders in the trial saw >10% increase in hair density at six months post-injection (see May 17, 2012 announcement). At 24 months, the average hair density increase for these same seven participants was 8.3% over baseline, and three of these seven trial participants maintained a >10% increase in density over baseline. The largest increase in hair density over baseline observed in this group was a 21% increase at 24 months.

The top 10 participants reported at least a 5% or greater increase in hair density at six months post-injection with an average increase of 11.8% (as reported in the May 17, 2012 announcement). This group demonstrated a sustained response at 24 months which averaged a 4.2% increase over baseline hair density. While there was a high degree of variability in hair density between individual participants at 24 months post-injection compared to baseline, an overall stabilization of hair loss was observed among all the patients treated per protocol.

Management Commentary
"The purpose of collecting efficacy data in these early-stage trials," stated RepliCel's Clinical Consultant, Darrell Panich, "is for our clinical team and management to obtain data that can be used to inform basic decisions about further development, provide provocative insights into the product's potential, and ¾ perhaps most importantly ¾ provide useful feedback which we can use to drive decisions about process and product development, ongoing research, and future clinical trial parameters."

"We are very pleased with the unquestionable safety profile of RCH-01," stated RepliCel's co-founder and Chief Medical Officer, Dr. Rolf Hoffmann. "Five-year safety follow-up is rare for cell therapy products and demonstrates our commitment to the highest quality of clinical research. Furthermore, the efficacy signals we see validate the research and development strategy we have had in place since we saw the six-month post-injection data in 2012."

Hoffmann continued: "Over the past 36 months, we have invested a great deal in both basic research and manufacturing optimization which we believe will be critical to minimizing batch-to-batch variability and further improving efficacy. We have invested in process and product development initiatives including a modified tissue culture technique, improved culture media with addition of 12 new ingredients, introduction of a cell activity promoting step, and cryopreservation storage to improve cell stability and viability. We believe these programs have already resulted in a significantly more robust and better-defined product than the one used in this trial by many measures and look forward to translating our continued R&D into next-phase clinical trials in due course."

"This trial involved the injection of a very high dose of DSCC in order to identify any potential toxicity ceiling in accordance with the primary safety objectives of the trial. The efficacy data we saw in this trial, together with recent animal research data, suggests that long-term survival of injected cells improves both with smaller dose size and with several sessions of injections spaced-out over a set time course to cumulatively increase injected cell numbers," stated RepliCel's co-founder and Chief Scientific Officer, Dr. Kevin McElwee. "We expect cell number and long-term cell survival to be correlative with hair density efficacy. Next-phase trials will be designed to test repeated injection sessions with smaller cell doses than were used in this study."

"Furthermore," continued McElwee, "with this 24-month post-injection data, and the availability of patient biopsy material and DSCC, we are now able to commence gene expression analysis with a goal of identifying the differences between products which result in superior responses and those that produce less-than-optimal responses. Ultimately, the goal here is to correlate and optimize cell dose and use repeat treatment sessions to achieve peak efficacy in terms of increased hair density."

"In summary," stated RepliCel's President and CEO, R. Lee Buckler, "we are very pleased with the results of this first-in-human study and are excited to move this product forward into the next phases of development."

Buckler concluded: "The analysis of data collected from this study, and the direction it gives our research and development programs, will support further optimization of the RCH-01 treatment to be evaluated in future phase II clinical trials. This data, combined with results expected next year from the Shiseido-funded study ongoing in Japan, will support future negotiations with regulators and licensees as we march toward RCH-01 commercialization. Additionally, we are confident that using RepliCel's RCI-02 injection device (currently under development) in future trials will better control the dose, distribution, and depth of injections to the scalp of study participants. We expect this to further positively impact the product's efficacy and the uniformity of response."

About the RCH-01 Clinical Trial (2011 - 2017)

The TS001-2009 first-in-human clinical trial was designed to test the safety and efficacy of dermal sheath cup cells (DSCC are the basis for the Company's current RCH-01 product) in men and women with androgenetic alopecia. The primary protocol objective of the study was to assess the local (at treatment sites) safety profile of injections. Secondary protocol objectives were to assess systemic (whole-body) safety and local efficacy (hair growth at treatment sites). A total of 19 subjects (10 male and nine female) were recruited for the trial and all of them completed 24-month post injection follow-up visits. Seventeen of those patients went on to complete a full five years of extended saftey evaluations to provide information on the long-term safety of DSCC injections. For further details about the trial design, endpoints, etc see https://www.clinicaltrials.gov/ct2/show/NCT01286649.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company's product pipeline is comprised of two recently completed clinical trials (RCT-01 for tendon repair and RCS-01 for skin rejuvenation), as well as, its RCH-01 hair restoration product under exclusive license by Shiseido Company for certain Asian countries. All product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles. RepliCel has also developed a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit http://replicel.com/ for additional information.

Forward-Looking Statements

This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: (i) that the RCH-01 product will move towards or be commercialized; (ii) that the RCH-01 product will revolutionize the way that hair loss is prevented, treated, and reversed; (iii) that clinical data from a study being conducted in Japan, financed by Shiseido, is expected in 2018; (iv) the Company's RCI-02 injection device (currently under development) will better control the dose, distribution, and depth of injections to the scalp of study participants and this will positively impact RCH-01's efficacy and the uniformity of response.

These statements are only predictions and involve known and unknown risks which may cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking statements, including: the risk that the Company will not obtain CE mark clearance or other necessary regulatory approvals for its injection device; the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company's clinical trials; the effects of government regulation on the Company's business; risks associated with Shiseido obtaining approval for its clinical trial; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company's ability to obtain and protect rights to its intellectual property; risks and uncertainties in connection with the outstanding issues alleged by Shiseido in connection with the License and Co-development Agreement; risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2015 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE RepliCel Life Sciences Inc.

RepliCel Pursues Non-Diluting Grant Funding to Accelerate Value Creation and Commercialization

VANCOUVER, March 7, 2017 /PRNewswire/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the "Company"), a clinical stage regenerative medicine company developing unique biologic products for pattern baldness and thinning hair, aging and sun-damaged skin, and chronic tendon degeneration, today announced the company has retained The FreeMind Group ("FreeMind"), a premier international firm that assists life science organizations in securing non-dilutive funding from granting agencies and private foundations. RepliCel aims to secure non-dilutive capital to support research, clinical development, and/or manufacturing priorities to accelerate value creation and the commercialization of its products.

"We have a number of strategic clinical and non-clinical projects which are ideally positioned for external collaborations and non-dilutive funding. These include basic research, manufacturing optimization, product development, and clinical objectives which have the potential to create significant intellectual property and shareholder value," stated RepliCel President and CEO, R. Lee Buckler. "FreeMind has a proven track record and commitment to success-based remuneration that convinces us they will bring significant value to our programs. I look forward to updating our shareholders over the coming months with their progress."

About The FreeMind Group
Established in 1999, The FreeMind Group is the largest consulting group of its kind working with academics and industry alike. Their goal is to assist in maximizing potential to receive funding from non-dilutive sources. They have experience in seeking funding from nearly all NIH Institutes, Department of Defense, NSF, FDA, BARDA, etc., as well as private foundations. FreeMind's team is dedicated to guiding non-dilutive funding efforts from identification of the most suitable opportunity, through to submission and subsequent award. Their expertise in applying for grants and contracts extends throughout every government mechanism, as well as private foundations open to funding the life sciences. FreeMind's proven long-term approach has garnered over $1.5 billion to date; awards range from $150,000 to $150 million per client project. For more information, visit http://www.freemindconsultants.com.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company's product pipeline is comprised of two ongoing clinical trials (RCT-01 for tendon repair and RCS-01 for skin rejuvenation) as well as its RCH-01 hair restoration product under exclusive license by Shiseido Company for certain Asian countries. All product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles. RepliCel has also developed a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit http://replicel.com/ for additional information.

Forward-Looking Statements
This and related press release contain forward-looking statements and information that involve various risks and uncertainties regarding future events. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2015 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE RepliCel Life Sciences Inc.

RepliCel Signs Two Key Service Partnerships for Final Prototype Manufacturing and Testing of its Dermal Injector

Two European firms team up to lead RepliCel's next-generation dermal injector (RCI-02) to market-ready status

VANCOUVER, Feb. 28, 2017 /PRNewswire/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the "Company"), a clinical stage regenerative medicine company developing unique biologic products for pattern baldness and thinning hair, aging and sun-damaged skin, and chronic tendon degeneration, today announced it has recently signed agreements with two European firms both of whom have committed to work with RepliCel to get the Company's commercial-grade RCI-02 dermal injector prototypes manufactured and tested.

"The execution of these agreements covers what we believe to be the final stages needed to prepare RCI-02 for a market authorization application in the form of a CE mark in Europe," stated RepliCel President and CEO, R. Lee Buckler. "With our first functional protoypes scheduled for this summer, we continue to work toward having this device ready for a CE mark application and in the hands of a licensing and commercial partner next year," stated Buckler. "Meanwhile," he concluded, "while we had originally hoped to receive some of our clincal data in February, we remain confident all three clinical data sets will be received and announced very shortly and all still before the end of the Quarter."

AMI is an Austrian manufacturer of medical technology based near the shores of Lake Constance, within easy reach of Germany and Switzerland. AMI develops, manufactures and distributes their medical products throughout the world. All of them are made according to the highest quality standards and enable doctors to take even better care of their patients.

"We are proud of our unique working relationship with AMI given that they typically only work on their own products," stated RepliCel's Co-Founder and Chief Medical Officer who is also a practicing dermatologist in Germany. "Their commitment to working with us on our device is a testament to their belief in the product's value and its ultimate potential to be widely adopted by the aesthetics industry."

Art of Technology ("AoT"), based in Zurich Switzerland is an independent contract developer specializing in the design, development and miniaturization of complex customer specific electronic devices and embedded systems for use in industrial, medical and space applications. Certified in accordance with ISO9001 and ISO13485, the firm emphasizes consistent quality documentation throughout the duration of a project including risk analysis, management and technical documentation to support CE approval.

About RCI-02
The RCI-02 injector was designed with input from dermatologists, industrial designers, and electronic and medical device engineers to improve the delivery of a variety of injectables in a controlled, precise manner, removing the risks and uncertainties of injection outcomes currently resulting from manually operated, single-needle syringes.

RCI-02 is the world's first motorized injection device with programmable depth and volume, a built-in Peltier element for pre-injection anaesthetising, and interchangeable needle head configurations. It is designed to deliver a variety of injectable substances including cells, dermal fillers, drugs or biologics intradermally (dermis), subcutaneously (fat) or intramuscularly (muscle) via an array of needle configurations ranging from a single needle to a 16 needle configuration (4x4) on one head. These interchangeable heads can be used to perform a variety of procedures, increase surface area coverage and speed-up procedure times.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company's product pipeline is comprised of two ongoing clinical trials (RCT-01 for tendon repair and RCS-01 for skin rejuvenation) as well as its RCH-01 hair restoration product under exclusive license by Shiseido Company for certain Asian countries. All product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles. RepliCel has also developed a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit http://replicel.com/ for additional information.

Forward-Looking Statements
This and related press release contain forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: (i) that the dermal injector device will result in a near term commercial opportunity for revenue generation; (ii) that the dermal injector will improve the injection of hyaluronic acid-based dermal fillers; (iii) that the device's simplicity and programmability is expected to enable less-experienced injection specialists to deliver predictable and consistent outcomes; (iv) that the dermal injector will be RepliCel's next licensing deal; (v) that the dermal injector, once developed, will represent game-changing reliability, reproducibility, and programmability of three dimensional skin injections; (vi) that future iterations of the technology and device will be optimized for other injectables such as drugs, biologics, vaccines, fat grafts, etc.; (vii) that the device will be ready for a CE-mark application and potential market launch in 2018; (viii) that the overall benefits of dermal injector technology include improved handling, reduction or elimination of the need for local anesthetic, quicker procedure times, improved patient experience, and a significant expansion of the areas that can be addressed with dermal fillers due to the ability to conduct broad, shallow, and evenly-dispersed injections; (ix) that the device will have a profound impact on all dermal injections; and (x) the dermal injector device will be able to be used for fine wrinkles across broad areas, like fine wrinkles in the face, hands and décolleté. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking statements, including: the risk that the Company will not obtain CE mark clearance or other necessary regulatory approvals; the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company's clinical trials; the effects of government regulation on the Company's business; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company's ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2015 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE RepliCel Life Sciences Inc.

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About RepliCel Life Sciences Inc. :

WAbout Us
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions linked to a deficit of healthy cells required for normal healing and function.

Products / Markets. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aged skin, and pattern baldness. The company is also developing a propriety, next-generation injection device (RCI) for optimal clinical delivery. Each condition is related to a deficit of a specific cell type which we believe is critical to the restoration of normal function.

Technology / IP. Innovative technology protected by both patents (issued and filed) and trade secrets on the cell isolation, product composition, manufacturing and clinical applications.

Partnerships. Shiseido has an exclusive license for RCH-01 in certain Asian countries including Japan, China and South Korea. The company is actively engaging potential partners for its other products.

Milestones. Management launched a clearly defined 18-month value creation plan in Q1 2015. The Company is launching multiple clinical trials anticipated in 2015 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development which includes clinical data from two trials, launch of other trials, execution of other licensing deals, a healthier cash position, CE mark for the RCI injector device, multiple manufacturing improvements, and specific research programs targeting other products and applications.

Executive Team
RepliCel’s Executive Team

RepliCel has attracted a seasoned, entrepreneurial management team with extensive experience in business management, the life sciences, and the pharmaceutical industry. Individual team members have established track records in their respective scientific or business fields.

R. Lee Buckler, B. Ed, LLB
President, CEO & Director
Mr. Buckler has been an executive in the cell therapy sector since 2000 beginning with Malachite Management in the Stem Cell Technologies group of companies. Most recently he was the Managing Director of Cell Therapy Group, a firm he formed in 2008 where he did business development consulting for companies and organizations in or interested in the cell therapy sector. His work included deal-targeting, transactions, market intelligence, competitive analyses, strategic assessments, and market profile planning for companies ranging from top-tier multinationals to start-ups. Mr. Buckler has a Bachelor’s Degree in Education and a Law Degree. After law school, he did a one year judicial clerkship with the B.C. Supreme Court and was a practicing attorney for three years at Edwards, Kenny & Bray. Mr. Buckler served six years as the Executive Director of the International Society for Cellular Therapy and just over two years as Director of Business Development for Progenitor Cell Therapy. He is on the editorial advisory boards of the journal Regenerative Medicine and the BioProcess International magazine as well as the Co-Chair of the Alliance for Regenerative Medicine’s Communications and Education Committee. He co-founded Cell Therapy News, founded Cell Therapy Blog, founded and continues to manage the LinkedIn Cell Therapy Industry Group, co-founded Regenerative Medicine Jobs, and is an active industry commentator in publications and in social media. Mr. Buckler serves on numerous industry conference advisory boards, is an advisory board member for BioCision, Phacilitate Cell & Gene Therapy and RoosterBio, and is on the Board of Directors for Hemostemix.

Dr. Rolf Hoffmann, MD
Chief Medical Officer
Dr. Hoffmann is a European-based clinical researcher who has spent decades researching the fields of pattern hair loss, alopecia areata, endocrinology of the hair follicle and hair follicle morphogenesis. Together with Dr. McElwee, he is the applicant of a landmark patent on the use of hair follicle cup cells and their use in hair diseases. He is working clinically in his private practice, as a teaching professor in the Department of Dermatology for Marburg University, as well as a researcher on histopathology on hair diseases, where he has published chapters in text books. Dr. Hoffmann has participated in dozens of clinical hair studies and consulted for a variety of large companies on hair matters. He is the inventor of TrichoScan®, a computerized technique to measure hair growth. Since then, he has run a successful privately owned company to market the device for dermatologists and to offer it as a service for clinical trials.

Dr. Kevin McElwee, PhD
Chief Scientific Officer
Dr. McElwee, co-discoverer of the Company’s technology, is an Associate Professor in the Department of Dermatology and Skin Health at the University of British Columbia, and Director of the Hair Research Laboratory in the Vancouver Coastal Health Research Institute at Vancouver General Hospital (VGH). His research is funded by competitive grants awarded by multiple organizations including the Canadian Institutes for Health Research (the equivalent of the National Institutes for Health in the USA). Dr. McElwee is one of only a small group of research scientists worldwide who studies hair biology and associated diseases. He has worked as a hair research scientist for 12 years and has published over 70 medical journal articles, research abstracts and academic book chapters on hair loss research. Dr. McElwee received his Bachelor of Science degree from the University of Aberdeen, Scotland and his PhD from the University of Dundee, Scotland. Postdoctoral training included three years at the Jackson Laboratory in Maine and four years at the University of Marburg, Germany, studying various hair loss diseases.

Tom Kordyback, CA
Chief Financial Officer
Tom Kordyback is a Chartered Accountant and a member of the British Columbia Institute of Chartered Accountants with over 25 years of experience in corporate finance and management for emerging growth companies. From 1984 to 1994, he held senior financial positions with Glenayre Electronics Inc. and Telelink Communications Inc. and worked as a consultant to other Vancouver area companies. In 1995, he began working for Creo, now part of Eastman Kodak Company as their Chief Financial Officer. In this role he oversaw private financings totally over $80 million and in 1999 he led the company’s Initial Public Offering on NASDAQ. He remained at Creo until 2000; at which time, the company had over 4000 employees worldwide. In 2004, Mr. Kordyback joined Extreme CCTV Inc., a developer and manufacturer of state-of-the-art surveillance systems listed on the TSX. He worked for them for three years as a director and member of its Audit, Compensation and Merger and Acquisitions Committees. In 2008 the company was sold to Bosch Security Systems, Inc. for CDN $93 million. Mr. Kordyback currently serves as a director of Silver Sun Resources Corp., a public Canadian-based resource company.

Darrell Panich, MSc, PMP, CPM
Clinical Consultant
An experienced clinical trial management specialist, Mr. Panich has managed multinational clinical research studies in more than 15 different countries for over 20 different pharmaceutical and biotechnology companies. He obtained his Master of Science degree from the University of Alberta while conducting clinical research in neuroscience. Mr. Panich has obtained certifications in project management from the Project Management Institute (Project Management Professional; PMP) and Project Management Leadership Group (Certified Project Manager; CPM).

RepliCel’s product pipeline leverages the unique cellular properties of the hair follicle to develop a portfolio of products that use cells for healing. RepliCel’s cell therapy products are developed to address specific functional cellular deficits which occur as a result of injury, normal aging or genetic predisposition leading to a variety of health conditions.

Future Product Pipeline

RepliCel is investing in research which has the potential to lead to a number of future products including:
• Other chronic tendinopathies (e.g., patellar tendinosis, tennis elbow, golfer’s elbow, rotator cuff)
• Other dermatologic indications (e.g, acne scaring, etc)
• Gingivitis
• Allogeneic versions of its proven autologous cell therapies

RCT-01 – Tendon Repair
NBDS Fibroblast Therapy – Treatment for Chronic Tendinosis

RCT-01 Development Status

RCT-01 is an autologous cell-based treatment utilizing non-bulbar dermal sheath (NBDS) cells isolated from the hair follicle sheath to treat chronic tendinosis caused by acute and chronic tensile overuse. The company has received Health Canada Clearance and UBC Ethics approval to conduct its Phase 1/2 clinical trial for the treatment of chronic Achilles tendinosis. The RCT-01 chronic Achilles tendinosis clinical research study will take place at the University of British Columbia in Vancouver, BC.

RCS-01 – Skin Rejuvenation
NBDS Fibroblast Therapy – Treatment for Aging Skin

RCS-01 Development Status

The company received approval from the German Competent Authority, the Paul-Ehrlich-Institut (PEI) for its Phase 1 clinical trial investigating the use of RCS-01 to treat patients suffering from aged and UV-damaged skin in August 2015. The study, entitled, “Randomized, double-blind, placebo-controlled, single-centre, phase 1 safety study of intra-dermal injections of RCS-01 in male and female subjects (50 to 65 years old)”, addresses the inherent deficit of active fibroblasts required for the production of type 1 collagen, elastin and other critical extracellular dermal matrix components found in youthful skin. The trial is being conducted at the IUF Leibniz-Institut für umweltmedizinische Forschung GmbH in Germany.

RCH-01 – Hair Regeneration
DSC Cell Therapy – Treatment for Androgenetic Alopecia

RCH-01 Development Status

RCH-01 is an autologous cell therapy utilizing dermal sheath cup (DSC) cells isolated from the hair follicle to treat androgenetic alopecia. RepliCel’s proposed Phase 2 trial will enroll 160 male subjects in good health with mild to moderate androgenetic alopecia. Dermal sheath cup cells will be isolated from a small punch biopsy taken from the back of the subject’s scalp. These cells will be replicated and then reintroduced into balding areas on the subjects scalp. After injections are performed subjects will return to the clinic for assessment of total, terminal and vellus hair density and cumulative hair thickness, as well safety. Participants will remain in the trial for approximately 39 months.

RCH-01 is now under clinical investigation at Tokyo Medical University Hospital and Toho University Ohasi Medical Center, by Drs. Tsuboi and Niiyama.

The study is being financed by Shiseido Company and each product being injected will be manufactured by Shiseido at their SPEC (Cell-Processing and Expansion Center) facility in Kobe, Japan. RepliCel helped Shiseido design, validate, and prepare the SPEC facility for certification by Japan’s PMDA (Pharmaceuticals and Medical Device Agency). Shiseido’s SPEC team was also trained by RepliCel and Innovacell in the GMP (Good Manufacturing Practice) compliant production protocols for RCH-01.

RCI-02 – Dermal Injector
Dermatology Injector Device

RCI-02 Development Status

RCI-02 is a next-generation dermal injector designed to provide an improved level of control and precision for intradermal (dermis), subcutaneous (fat) or intramuscular injections. Originally designed to support the injection of RepliCel’s RCH-01 and RCS-01 cell therapy products, the injector has broader applications for dermatological procedures requiring injections of specific volumes of material at specific depths including cellular products, fillers, hyaluronic acids, fat and collagen injections.

Technology
RepliCel is built on its unparalleled scientific knowledge of the unique biological characteristics of hair follicle cells and its technical, clinical and commercial expertise to develop, manufacture and deliver propriety products designed to address specific cell deficits or loss of cellular function resulting in chronic health conditions.

.SOURCE: http://replicel.com/

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