Objectives: (1) To culture collagen-producing cells derived from skin fibroblasts and, (2) To evaluate prospectively the safety and potential use of this cell preparation for treatment of refractory lateral epicondylitis (CEO tendinosis) in a pilot study.
Design: Prospective clinical pilot study.
Setting: Institution based clinical research.
Patients: Twelve patients (5 men and 7 women; mean age 39.1 years) with clinical diagnosis of refractory lateral epicondylitis.
Interventions: Laboratory-prepared collagen-producing cells derived from dermal fibroblasts were injected into the sites of intra-substance tears and fibrillar discontinuity of the common extensor origin under ultrasound guidance.
Main outcome measurements: The outcome assessment was done over 6 months using (i) Patient-Rated Tennis Elbow Evaluation scale for pain severity and functional disability and (ii), the tendon healing response was measured using four criteria on ultrasound – tendon thickness, hypoechogenicity, intra-substance tears and neovascularity.
Results: Successful preparation of cell cultures rich in collagen-producing cells was possible in laboratory. After injection, the median PRTEE score decreased from 78 pre-procedure status to 47 at 6weeks, 35 at 3months and 12 at 6months (p<0.05). The healing response on ultrasound showed median decrease in – (a) number of tears from 5 to 2, (b) number of new vessels from 3 to 1 and, (c) tendon thickness from 4.35 to 4.2 (p<0.05). Eleven of the 12 patients had a satisfactory outcome such that only one patient proceeded to surgery following failure of treatment at the end of 3months.
Conclusions: Skin-derived tenocyte-like cells can be cultured in the laboratory to yield a rich preparation of collagen-producing cells. Our pilot study suggests that these collagen-producing cells can be injected safely and may have therapeutic value in patient’s suffering from refractory CEO tendinosis.