RCT-01-001-2014: Clinical Trial to Evaluate Cell Therapy for the Treatment of Chronic Achilles Tendinosis
A clinical research study is currently being conducted at the University of British Columbia on an experimental cell therapy product as a potential treatment for chronic tendinosis of the Achilles tendon (Achilles tendinosis). The proposed new treatment is called RCT-01. It is comprised of collagen-producing cells that have been isolated from your own body. Collagen is one of the main components of human tendons. The proposed treatment may increase the amount of collagen-producing cells by directly injecting them into the affected area of the tendon. Collagen-producing cells are found in several areas of the body including the skin, tendon and the scalp. The treatment for this study would involve taking a small amount of these cells from your scalp, multiplying them in the lab and then injecting these cells directly into your damaged tendon. This is a phase I/II study which means that this treatment has been tested in animals. However, this is the first study that tests RCT-01 in humans. Data from this study will be used to evaluate how safe injections of RCT-01 are in humans and to determine if RCT-01 is an effective treatment for chronic Achilles tendinosis.
What does the study involve?
Participants that meet the initial screening criteria will need to have their overall health assessed. The diagnosis of Achilles tendinosis will be confirmed by the study doctor and radiologist. Participants will also need to provide blood samples that will be screened for viral infections.
Participants that qualify for the study will then need to provide a skin biopsy from the back of the scalp, approximately the diameter of the end of a pencil (6mm), which will require 1-2 sutures to close. This biopsy will be sent to a laboratory where it will be dissected and specific cells will be isolated and grown. These cells will be used in the preparation of the experimental cell therapy product called RCT-01.
Approximately 7 weeks after providing the biopsy, participants will be contacted to schedule a clinic visit. At the clinic visit, they will receive either an injection of RCT-01 (cells in liquid carrier) or of liquid carrier without cells (placebo) directly into the Achilles tendon after the area has been frozen. The doctor will use ultrasound imaging to guide the injection.
Over the next six months, participants will need to return to the study centre 7 times to assess overall health and tendinosis using ultrasound or other imaging. At 5 of these visits, a blood sample will be taken. At 4 of these visits, questionnaires will need to be filled out. Participants are also required to attend 4 physiotherapy sessions with a certified physiotherapist to undergo post-treatment therapy to help facilitate treatment of Achilles tendinosis. The total time to take part in this study is estimated at 19 hours.
Once the 6-month follow-up period is complete, participants will be invited to take part in a follow-up study that will last for an additional 18 months. The purpose of the 18-month study is to allow for the collection of information 24-months post-injection.
You can complete the following quiz to see if you may qualify for participation in this clinical trial.