This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Spinal Cord Injury.
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Spinal Cord Injury (SCI). This patient funded trial aims to study the safety and efficacy of intravenous and intrathecal delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of SCI. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Medical Surgical Associates Center
St John's, Antigua and Barbuda
RECRUITINGAthens Beverly Hills Medical Group
Glyfada, Athens, Greece
RECRUITINGSafety (adverse events)
Clinical monitoring of possible adverse events or complications
Time frame: Four year follow-up
Efficacy: American Spinal Injury Association Impairment Scale (ASIA)
It will be completed for each follow up point
Time frame: Four year follow-up
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