Regeneration of the lumbar intervertebral disc using MSV*

Nº EudraCT: 2008-001191-68

Objectives

Clinical trial to assess the efficacy and safety of MSV implantation as treatment for intervertebral lumbar disc degeneration, together with its ability to regenerate the disc.

Methodology

Phase I-II, open-label, prospective and unicentric clinical trial. 10 patients, both men and women, aged 36 years old on average, presenting degenerative discopathy with clinical repercussion were included.

A single intra-discal percutaneous injection of autologous expanded bone marrow mesenchymal stem cells was performed, and changes were evaluated at 6 and 12 months.

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

Efficacy was evaluated using clinical criteria based on MRI T2 Mapping Cartigram®, 6 and 12 months after infiltration. Efficacy was also determined by clinical evolution criteria (VAS questionnaire and OSWESTRY score) and quality of life evolution (SF-36).

Results

Safety
The treatment shows a good safety profile. A total of 20 adverse effects were registered in 11 patients included in the study, all of them being mild in nature and not related to the administration of the study treatment (10 patients were eventually treated). 1 patient presented an oedema in the iliac crest, related to the procedure for obtaining bone marrow, with a favourable evolution. This experience was classified as exceptional and with an incidence of 1/1000
.

Efficacy
9 out of 10 patients improved significantly. The analgesic effect was remarkable (about 71% effective), quick (85% achieved improvement in 3 months) and was accompanied by a parallel improvement in the degree of disability and quality of life.
Evaluation of regenerative efficacy was evidenced by the amount of fluid contained in the treated discs, which increased significantly after the injection
.

Conclusions

The intra-discal percutaneous infiltration of MSV has a good safety profile and promotes disc regeneration at 12 months. In addition, it significantly reduces pain and disability, while improving the quality of life.

Publications

Orozco L, Soler R, Morera C, Alberca M, Sanchez A, Garcia-Sancho J. Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study. Transplantation. 2011;92(7):822-828.
Morera C, Soler R, Alberca M, Velázquez J, Sánchez A, Orozco L. Regeneration of the Lumbar Intervertebral Disk by Means of MSV* (*Autologous Bone Marrow Stem Cells Expanded According to the GMP Methodology). The Journal of Orthopaedics Trauma Surgery and Related Research (Poland). 2010;4(20):121.

STUDY DESCRIPTION

Unicentric study
Development phase: I-II
Status: completed, published
Nº EudraCT: 2008-001191-68
Code: MSV-Crio
Sponsor: ITRT
CEIC: Centro Médico Teknon
CRO: Trial Form Support
Investigators: L Orozco, R Soler Rich, A Sánchez, J García Sancho, F Pastor, M Alberca, F Soler, JJ Velázquez, C Morera, A Leist, J Sentís
Participating entities: ITRT, Centro Médico Teknon, IBGM (Valladolid University and CSIC), EGARSAT, Facultad de Medicina University of Barcelona
Funding: Advanced Therapy Plan 2007, Ministry of Health and Consumption

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