Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC),
obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial
is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We
propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and
controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay
consists of two arms with 15 patients each one. Patients in the experimental arm will be
given an intra-articular transplantation of allogenic MSC, expanded "Ex Vivo" with our
GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as
in NCT01183728). In the control arm a standard treatment with intra-articular injection of
hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of
life and quantitative changes in structure and composition of cartilage determined by
T2-weighted MRI relaxation (Cartigram) for one year.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Red de Terapia Celular
Collaborators:
Centro Medico Teknon Sanidad de Castilla y León Sanidad de Castilla y Leon (SACYL) University of Valladolid