RepliCel Injects Their Final Subject in Their Tendon Repair Clinical Trial


RepliCel Life Sciences Inc., a biotechnology company based in Irvine, California, has reported the administration of the final injection in its phase 1 safety trial of their proprietary product RCT-01 in the treatment of patients with chronic Achilles tendinopathy.

RepliCel’s RCT-01 consists of cells taken from a patient’s own hair follicles. These “non-bulbar dermal sheath” or NBDS cell are isolated from the hair follicle sheath and expanded in culture.

nbds-cells-follicle

In this clinical trial, the NBDS cells are used to treat patients with chronic tendinosis, a condition caused by acute and chronic tendon overuse. RepliCel 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.

RepliCel’s Phase 1/2 trial will enroll 28 subjects, all of whom suffer from chronic tendinosis and have failed traditional tendon treatments, but are, otherwise, in good health.

NBDS cells will be isolated from a small punch biopsy taken from the back of the scalp, expanded in culture and then reintroduced into the wounded tendons under the guidance of ultrasound. After these injections, all subjects will return to the clinic for assessments of safety, function and pain, as well as changes in tendon thickness, echotexture, interstitial tears and neovascularity.

Since the last patient has been injected with their own NBDS cells, the last scheduled patient visit to collect treatment follow-up data will be in late November. All data from this trial will be assessed for clinical safety of NBDS cells and six-month efficacy. These data should be un-blinded and made available for analysis and dissemination near the end of this year. year-end.

This trial is designed to ascertain the signs of efficacy but it is simply not statistically powerful enough to draw any strong conclusions about efficacy.

“What we are looking for is a convincing signal, in at least some of the treated patients, that the product has clinically relevant outcomes in terms of restoration of function, reduction of pain, and/or regeneration of the tendon structure as measured by ultrasound imaging,” said RepliCel’s Rolf Hoffmann.

Data from this trial, will, however, inform and guide RepliCel’s product development and clinical trial strategy not only for Achilles tendinopathy but also for several other tendon repair applications including the treatment of jumper’s knee, golfer’s elbow, tennis elbow, and rotator cuff.

RCT-01 contains, largely, type 1 collagen-expressing fibroblasts derived from the hair follicle. These NBDS fibroblasts have the potential to address many clinical conditions that result from a deficiency of active fibroblast cells, which are required for tissue remodeling and repair.

NBDS fibroblast cells, isolated from healthy hair follicles, are a rich source of fibroblasts unique in their high-level expression of the necessary proteins, such as Type I collagen, which can jump-start the stalled healing cycle.

RepliCel is in the process of developing a series of products from this platform that have the potential to address large commercial markets in the areas of musculoskeletal and skin-related conditions.

RepliCel Skin Rejuvenation and Tendon Repair Trials With Hair Follicle Stem Cells Underway


RepliCel Life Sciences has enrolled subjects for their skin rejuvenation and tendon repair trial.  The primary goal of these trials is to determine the safety of their cell therapeutic products.

NBDS-Cells-Follicle

In the first trial will test a product called RCS-01, which consists of cells derived from non-bulbar dermal sheath (NBDS) cells, which are taken from the outer regions of hair follicles.  NBDS cells express type 1 collagen, a protein that is steadily degraded in aged skin (hence the formation of wrinkles).  Therefore, RepliCel is confident that RCS-01 injections underneath the skin has the potential to rejuvenate aged or damaged skin.  The trial will examine male and female subjects, between 50-65 years old, and will address 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 will be conducted at the IUF Leibniz-Institut für umweltmedizinische Forschung GmbH in Dusseldorf, Germany.  Originally, RepliCel wished to enrolled 15 men and 15 women, but the large number of female subjects and paucity of men persuaded the company to move forward with the trial despite only enrolling a few men and all the projected women.

The second trial will test the safety and efficacy of RCT-01 in the repair of damaged Achilles tendons.  RCT-01 also consists of NBDS cells and this trial is a phase 1/2 clinical trial that examines the ability of NBDS cells to treat chronic tendinosis caused by acute and chronic tensile overuse.  This trial will take place at the University of British Columbia in Vancouver, BC, and will only treat 10 subjects.  Even though RepliCell wishes to originally test 28 participants, the company shorted the trial in order to have safety data by the end of 2016.

Darrell Panich, RepliCel Vice President of Clinical Affairs, said that the company had a late start on its trials, and therefore truncated the recruitment process in order to have safety data for analysis by the end of 2016.  Despite the small size of these trials (and they are small), the company is hopeful that their safety data will provide the impetus for moving forward with larger phase 2 trials.

Panich said, “We have adjusted our plans for the RCT-01 clinical trial in part because it started later in 2015 and enrolled slower than originally anticipated. While the trial did not meet projected enrollment targets, we are confident the safety and preliminary efficacy data obtained by year-end will provide a signal of the product’s potential to regenerate chronically injured tendon that has failed to respond to other treatments. This will allow our teams to effectively plan larger phase 2 trials in 2017 which are powered to be statistically significant for clinical efficacy (evidence the product works as intended).”

“Future trials involving products from our non-bulbar dermal sheath (NBDS) platform will be designed to investigate the efficacy of these products at different dose levels and treatment frequencies while continuing to collect other data that will be used to support eventual RCS-01 and RCT-01 marketing applications by our commercial partners.”

“The delivery of clinical data when promised is important to management”, said R. Lee Buckler, President & CEO, RepliCel Life Sciences Inc. “We have made critical decisions to keep our commitment to the financial community and we believe the data from these trials will facilitate us closing a licensing and co-development deal on one or both of these products similar to the kind we have in place with Shiseido Company for our RCH-01 product,” he added.

RepliCel is confident that their NBDS fibroblast platform will address numerous indications where impaired tissue healing has been stalled due to a paucity of active fibroblasts, which are required for tissue remodeling and repair.  NBDS fibroblasts, isolated from the hair follicles of healthy individuals, are a rich source of fibroblasts and are unique in their ability to express high levels of type 1 collagen and elastin to push-start the healing process.

RepliCel is also developing products from this same platform to address larger commercial markets in the areas of musculoskeletal and skin-related conditions.