A Phase I Study to Evaluate the Potential Role of Mesenchymal Stromal Cells in the Treatment of Refractory Achilles Tendinopathy
Achilles tendinopathy (AT) is a common disabling condition of middle age that is treated by exercises, modified activity, injections and occasionally surgery. Treatments are necessarily prolonged and the results of most interventions are generally disappointing and frustrating. The resulting tendon is repaired with type 3 collagen and fibrosis, meaning that recurrence does occur. Some patients do not recover and have ongoing morbidity requiring lifestyle changes and long-term activity modification. Pre-clinical studies, and equine therapies, suggest that mesenchymal stromal cells (MSCs) have the potential to regenerate tendon tissue and effectively treat tendinopathy. This presentation describes a world first in man trial, to assess the safety and efficacy of MSCs in refractory AT.
Refractory AT is defined as: mid-substance AT, with a VISA score of <55, which has been present for at least 12 months, and which has not responded to an evidenced based eccentric exercise program. 9 subjects will be placed in 3 cohorts of 3, and receive an ascending dosage of 1, 4 or 16 x 106 MSCs. These will be implanted intratendinously under precision ultrasound guidance. All subjects will undergo further exercises, and be followed up for 6 months with regular clinical examinations and diagnostic and doppler ultrasound scanning. The first 3 participants have completed the trial and demonstrated a dramatic improvement in symptoms.
Status-Active, Not Recruiting.