Trials / Recruiting
RecruitingNCT05018793
Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for SCI
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- The Foundation for Orthopaedics and Regenerative Medicine · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | autologous adipose derived mesenchymal stem cells | cultured autologous adult adipose derived mesenchymal stem cells |
| BIOLOGICAL | AlloRx | Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal injection for |
Timeline
- Start date
- 2024-12-01
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2021-08-24
- Last updated
- 2025-04-17
Locations
2 sites across 2 countries: Antigua and Barbuda, Greece
Source: ClinicalTrials.gov record NCT05018793. Inclusion in this directory is not an endorsement.