Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)
Status:
Completed
Trial end date:
2017-04-01
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 Degenerative Disc Disease
(DDD). The trial is based in previous results with autologous MSC (Orozco et al.,
Transplantation 92: 822-828; 2011). Here we propose a phase I-II trial, prospective,
randomized, blinded, and controlled for the treatment DDD using MSV, a Good Manufacturing
Practice (GMP)-compliant expanded bone marrow MSC (MSV, PEI Num. 10-134). The assay consists
of two arms with 12 patients each one. Patients in the experimental arm will be given a
single intra-discal transplantation of MSV (25 millions in 2 ml). Control patients will be
infiltrated in the paravertebral muscles close to the lesion with 2 ml of 1% mepivacain. We
shall follow the evolution of pain, disability and quality of life as well as disc fluid
content by Magnetic Resonance Imaging (T2-calibrated).