Treatment of gonarthrosis with allogenic mesenchymal stem cells (MSV)*

ClinicalTrials.gov Identifier: NCT01586312
Nº EudraCT: 2011-005321-51

Objectives

Clinical trial to evaluate the efficacy and safety of the treatment with allogenic expanded bone marrow mesenchymal stem cells for knee osteoarthritis, together with its ability for cartilage regeneration.

Methodology

Phase IIb, randomized, double-blind, controlled and multicentre clinical trial. 30 patients were included, both men and women aged 57 years old on average.

Patients were randomized into two treatment groups: allogenic expanded bone marrow stem cells and control with hyaluronic acid. A single injection was performed, and the changes were evaluated over 12 months.

Safety was determined by the number of adverse effects (AE).

Efficacy was assessed with clinical criteria based on the degree of pain, disability and quality of life (VAS, WOMAC and LEQUESNE scores). Cartilage regeneration was determined by NMR T2 Mapping.

Results

Safety
Safety and efficacy of the intervention with allogenic mesenchymal stem cells was confirmed.

Efficacy
Cell therapy achieved a significant improvement in pain from 38 to 42% compared to 10-14% in the control group, with significant differences observed at 6 and 12 months. Similarly, there were also significant improvements in the degree of disability and cartilage regeneration.

Conclusions

Therapy with expanded allogenic mesenchymal stem cells may be a valid alternative for the treatment of knee osteoarthritis. The intervention is simple, does not require surgery and provides pain relief and significant improvements in cartilage quality.

The trial results showed similar benefits to those obtained with autologous cells and may be especially beneficial in patients carrying viral load (AIDS or hepatitis) in which case the cells cannot be cultivated in a clean room.

Publications

Vega A, Martin-Ferrero MA, Del Canto F, Alberca M, Garcia V, Munar A, Orozco L, Soler R, Fuertes JJ, Huguet M, Sanchez A, Garcia-Sancho J. Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial. Transplantation. 2015;99(8):1681-1690.

STUDY DESCRIPTION

Multicentre study
Development phase: IIb
Status: completed
PEI: 04-031
Nº EudraCT: 2011-005321-51
ClinicalTrials.gov: NCT01586312
Code: MSV allo
Sponsor: Parque Científico de la Universidad de Valladolid
CEIC: Universidad de Valladolid, Centro Médico Teknon
Control: Spanish Medicine Agency (AEMPS)
Investigators: A Vega, L Orozco, R Soler Rich, F Soler, A Sánchez, J García Sancho, M Alberca, M Huguet, F Soler Romagosa, X Peirau
Participating entities: Citospin, Centro Médico Teknon; Hospital Clínico Universitario de Valladolid; CETIR Clínica del Pilar; Teknon Foundation; IBGM (Valladolid University and CSIC)
Funding: Aid to Independent Investigation 2011

*MSV: Expanded bone marrow mesenchymal stromal cells ex vivo with a GMP procedure developed by Instituto de Biología Genética Molecular (IBGM) – Valladolid.