Elsevier

Cytotherapy

Volume 18, Issue 8, August 2016, Pages 1025-1036
Cytotherapy

Clinical Trials
An approach to personalized cell therapy in chronic complete paraplegia: The Puerta de Hierro phase I/II clinical trial

https://doi.org/10.1016/j.jcyt.2016.05.003Get rights and content
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open access

Abstract

Background aims

Cell transplantation in patients suffering spinal cord injury (SCI) is in its initial stages, but currently there is confusion about the results because of the disparity in the techniques used, the route of administration, and the criteria for selecting patients.

Methods

We conducted a clinical trial involving 12 patients with complete and chronic paraplegia (average time of chronicity, 13.86 years; SD, 9.36). The characteristics of SCI in magnetic resonance imaging (MRI) were evaluated for a personalized local administration of expanded autologous bone marrow mesenchymal stromal cells (MSCs) supported in autologous plasma, with the number of MSCs ranging from 100 × 106 to 230 × 106. An additional 30 × 106 MSCs were administered 3 months later by lumbar puncture into the subarachnoid space. Outcomes were evaluated at 3, 6, 9 and 12 months after surgery through clinical, urodynamic, neurophysiological and neuroimaging studies.

Results

Cell transplantation is a safe procedure. All patients experienced improvement, primarily in sensitivity and sphincter control. Infralesional motor activity, according to clinical and neurophysiological studies, was obtained by more than 50% of the patients. Decreases in spasms and spasticity, and improved sexual function were also common findings. Clinical improvement seems to be dose-dependent but was not influenced by the chronicity of the SCI.

Conclusion

Personalized cell therapy with MSCs is safe and leads to clear improvements in clinical aspects and quality of life for patients with complete and chronically established paraplegia.

Key Words

cell therapy
mesenchymal stromal cells
paraplegia

Cited by (0)

A complete list of investigators (Neurological Cell Therapy Group) and collaborators is provided in the Supplementary Appendix.