RepliCel Tendon-01 (RCT-01), hair follicle-derived-fibroblasts for treatment of tendinosis
RepliCel Tendon-01 (RCT-01) is a product comprised of autologous non-bulbar dermal sheath (NBDS) fibroblasts and has been tested in patients suffering from achilles, patellar or lateral elbow tendinosis.
Three phase I clinical trials for each of the above types of tendinosis (total of 104 tendons) were conducted. The results indicate that transplantation of skin-derived fibroblasts is safe and effective in repairing micro-tears in the tendon. The injected collagen-producing fibroblasts promoted the regeneration of damaged tendon tissue.
Phase II trials will use isolated hair follicle NBDS fibroblasts, that were shown to produce more than five times the amount of type 1 collagen compared to skin-derived fibroblasts cells. RCT-01 will be tested in approximately 90-120 subjects who have failed traditional treatments and who are otherwise in good health. After injections, patients will return to the clinic for assessments of safety, function and pain, as well as changes in structural tendon properties.
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An Achilles tendinosis phase II clinical trial is anticipated to be initiated in the first half of 2014.
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RepliCel Tendon-01 (RCT-01), hair follicle-derived-fibroblasts for treatment of tendinosis
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