Safety Study of Mesenchymal Stem Cells and Spinal Fusion

Summary

The present prospective, randomized study, compares the spinal fusion obtained after instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from his/her own bone marrow which will be fixed in human bone tissue form a donor), with the current procedure that consists in instrumented spinal fusion and the use of each patient's bone obtained from his/her iliac crest. The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its associated morbidity.

Timeline

Start

2012-07-19

Primary completion

2018-05-03

Completion

2019-10-21

Publications

• Vives J, Oliver-Vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy. 2015 Aug;17(8):1009-14. doi: 10.1016/j.jcyt.2015.02.002. Epub 2015 Mar 10.

Drugs

Indications