Articular cartilage regeneration in gonarthrosis grade II and III by articular infiltration of Xcel-m-condro-alpha*

ClinicalTrials.gov Identifier: NCT01227694
Nº EudraCT: 2009-016449-24

Objectives

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

Methodology

Phase I-II, open label, prospective and unicentric clinical trial. 15 patients were included, both men and women aged 52 years old on average, with gonarthrosis grade II and III and IV of Kellgren and Lawrence.

A single injection of autologous expanded bone marrow mesenchymal stem cells in knee joint was performed, and changes were evaluated at 6 and 12months.

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

Efficacy was evaluated with clinical criteria based on cartilage regeneration (MRI T2 Mapping Cartigram®) at 6 and 12 months after infiltration. Pain (VAS), functional status (HAQ) and quality of life (SF-36) were also evaluated.

Results

Safety
The treatment shows a good safety profile. There have been no significant adverse effects related to cell treatment.

Efficacy
Significant cartilage regeneration was evident in 100 % of patients 12 months after infiltration. Regeneration of the pathological points was also >70 % after 6 months.
At 12 months the pain intensity also decreased significantly (-38.8 points with respect to daily life activities, and 51.9 points in sports activity in the VAS questionnaire) and improved health status (disability level) and quality of life (body pain, function and physical role).

Conclusions

The cellular treatment has proven safe. Intraarticular infiltration of expanded mesenchymal stem cells favours cartilage regeneration of the affected areas of the knee 6 and 12 months after infiltration. In addition, treatment significantly reduces pain intensity and functional disability, improving the patient’s quality of life.

Publications

Soler R, Orozco L, Munar A, Huguet M, Lopez R, Vives J, Coll R, Codinach M, Garcia-Lopez J. Final results of a phase I-II trial using ex vivo expanded autologous Mesenchymal Stromal Cells for the treatment of osteoarthritis of the knee confirming safety and suggesting cartilage regeneration. Knee. 2016;23(4):647-654.

STUDY DESCRIPTION

Unicentric study
Development phase: I-II
Status: completed
PEI: 10-134
Nº EudraCT: 2009-017405-11
Code: MSV-ARTRO-2009-01
ClinicalTrials.gov: NCT01183728
Sponsor: Xcelia – Banc de Sang i Teixits
CEIC: Centro Médico Teknon
Control: Spanish Medicine Agency (AEMPS)
CRO: Trial Form Support
Investigators: R Soler Rich, L Orozco, F Soler, X Peirau, M Huguet, J García
Scientific collaboration: JC Vilanova, S Trattnig, A Munar
Participating entities: ITRT, Centro Médico Teknon, Xcelia, Banc de Sang i Teixits (BST), CETIR Clínica del Pilar, Teknon Foundation, EGARSAT
Funding: BST (MEDCEL Project, Secretary of State for Universities and Research)

*Xcel-m-condro-alpha: Autologous bone marrow stem cells expanded ex vivo a GMP procedure developed by XCELIA- División Terapias Avanzadas del Banc de Sang i Teixits