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Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for SCI

Spinal Cord Injuries Clinical Trial

Official title:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Spinal Cord Injury

Clinical Trial Summary

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.

Clinical Trial 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 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. For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05152290
Study type Interventional
Source The Foundation for Orthopaedics and Regenerative Medicine
Contact
Status Recruiting
Phase Phase 1
Start date July 6, 2022
Completion date January 2026
View Details
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