Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Spinal Cord Injury
Overview
- Phase
- Phase 1
- Intervention
- autologous adipose derived mesenchymal stem cells
- Conditions
- Spinal Cord Injuries
- Sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Safety (adverse events)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This trial will study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cells for the treatment of spinal cord injury
Detailed Description
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 intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells (AD-MSCs) versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cell for the treatment of SCI. Patients with SCI will receive a single intrathecal injection of AD-MSCs. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Spinal Cord Injury
- •Understanding and willingness to sign a written informed consent document
Exclusion Criteria
- •Active infection
- •Active cancer
- •Chronic multisystem organ failure
- •Pregnancy
- •Anticoagulation medicine use
- •Clinically significant Abnormalities on pre-treatment laboratory evaluation
- •Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
- •Previous organ transplant
- •Hypersensitivity to sulfur
- •Continued drug abuse
Arms & Interventions
Treatment Group
Single intrathecal injection of 100 million cells
Intervention: autologous adipose derived mesenchymal stem cells
Treatment Group
Single intrathecal injection of 100 million cells
Intervention: AlloRx
Outcomes
Primary Outcomes
Safety (adverse events)
Time Frame: Four year follow-up
Clinical monitoring of possible adverse events or complications
Secondary Outcomes
- Efficacy: American Spinal Injury Association Impairment Scale (ASIA)(Four year follow-up)