Spinal Cord Injury Clinical Trial
Official title:
Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in Patients Suffering Incomplete Spinal Cord Injury (SCI)
The study goes on 24 months, with recruiting, treatment and follow period for all patients.
The first day for each patient will be the first cellular administration. 3 doses will be
administrated every 3 months from first dose.
When the clinical trial finishes, it will be done a completed check of all obtained
parameters.
It is a clinical trial phase I, single center, non-randomized, uncontrolled, open prospective
follow-up of a cohort of patients with chronic spinal cord injury (SCI) .10 patients will be
included with this injury.
Primary objective: Analyze the possible clinical efficacy of administration of main adult
mesenchymal autologous cells expanded "in vitro" in patients with incomplete and chronically
established SCI.
Secondary objectives: Confirm the safety of treatment, and study possible changes in the
cerebrospinal fluid (CSF) levels (Brain-derived neurotrophic factor (BDNF), glial cell
line-derived neurotrophic factor (GDNF), nerve growth factor (NGF), ciliary neurotrophic
factor (CNTF), Nerve Growth Factor 3 and 4(NT3 and NT4) after subarachnoid administration of
BMMC.
;
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|---|---|---|---|
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||
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