Spinal Cord Injury Clinical Trial
Official title:
Phase I, Single Center, Trial to Asses Safety and Tolerability of the Intrathecal Infusion of Ex-vivo Expanded Bone-marrow Derived Mesenchymal Stem Cells for the Treatment of Spinal Cord Injury
This study is based on preclinical (animal) studies showing that infusing bone
marrow-derived mesenchymal stem cells into the spinal fluid may contribute to improving
neurologic function in animal models with spinal cord injuries. Bone marrow (BM) contains
several types of stem cells that can produce functional cells. This includes cells that
could help the healing process of damaged neurologic tissue.
The primary objective of this study is to see if the injection of these cells, obtained from
your own bone marrow, is safe. A secondary objective is to evaluate if the treatment can
provide functional improvements (neuromuscular control and sensation) in the affected areas.
A Phase I, single-center trial to assess the safety and tolerability of an intrathecal
infusion (lumbar puncture) of autologous, ex vivo expanded bone marrow-derived mesenchymal
stem cells in a well-defined population of spinal cord injury patients.
Safety will be evaluated by neurological and non-neurological tests performed after
short-term (1 to 30 days) and long-term (2 to 12 months)follow-up evaluation periods after
cell infusion.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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