Pilot clinical trial to determine the efficacy and safety of cryopreserved MSV* in the treatment of gonarthrosis

Nº EudraCT: 2012-004441-32

Objectives

Clinical trial to assess the efficacy and safety of treatment with expanded bone marrow cryopreserved mesenchymal stem cells for gonarthrosis.

Methodology

Phase IIa, open-label, prospective and unicentric clinical trial. 3 patients diagnosed with gonarthrosis grade II to IV and with clinical repercussion were included.

During the cultivation procedure, a cryopreservation period of the cells was intercalated. Subsequently, they were revitalized until the determined cell dose was reached and the cellular treatment was applied to the patients, maintaining established safety and efficacy follow-up.

Safety was determined by the number of adverse effects (AEs) related to the study treatment and the percentage of patients who had a reacted AE.

Efficacy was evaluated with clinical criteria and cartilage regeneration using MRI T2 Mapping 6 and 12 months after infiltration of MSV-Crio.

Results

Safety
Safety and efficacy of cryopreserved mesenchymal stem cells was confirmed.

Efficacy
Patients presented a good clinical evolution. 2 out of 3 patients showed significant clinical improvements, as well as regenerative efficacy in cartilage.

Conclusions

The cryopreservation process has proven effective in all preliminary in vitro studies. The hypothesis raised and confirmed in this trial is that the process of cryopreservation and revitalization to normal does not alter the therapeutic potential or the safety of cell use, which allows for the storage of cryopreserved cells for future applications.

STUDY DESCRIPTION

Unicentric study
Development phase: IIa
Status: completed
PEI: 10-134
Nº EudraCT: 2012-004441-32
Code: MSV-Crio
Sponsor: Teknon Foundation
CEIC: Centro Médico Teknon
CRO: ADKNOMA
Control: Spanish Medicine Agency (AEMPS)
Investigators: L Orozco, R Soler Rich, F Soler, A Sánchez, J García Sancho, M Alberca, F Soler Romagosa, X Peirau
Participating entities: ITRT, Centro Médico Teknon, Citospin, CETIR Clínica del Pilar, IBGM (Valladolid University and CSIC)
Funding: Aid to Independent Investigation 2011

*MSV: Autologous bone marrow mesenchymal progenitor cells expanded with IBP GMP procedures