Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for SCI

Phase 1

Recruiting

• Conditions: Spinal Cord Injuries
• Interventions: Biological: autologous adipose derived mesenchymal stem cells; Biological: AlloRx

• Registration Number: NCT05018793
• Lead Sponsor: The Foundation for Orthopaedics and Regenerative Medicine

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.

Study Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-24
• Study Start: 2024-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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
• Pre-menopausal women not using contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	autologous adipose derived mesenchymal stem cells	Single intrathecal injection of 100 million cells
Treatment Group	autologous adipose derived mesenchymal stem cells	Single intrathecal injection of 100 million cells
Treatment Group	AlloRx	Single intrathecal injection of 100 million cells

Primary Outcome Measures

Name	Time	Method
Safety (adverse events)	Four year follow-up	Clinical monitoring of possible adverse events or complications

Secondary Outcome Measures

Name	Time	Method
Efficacy: American Spinal Injury Association Impairment Scale (ASIA)	Four year follow-up	It will be completed for each follow up point

Trial Locations

Locations (2)

Medical Surgical Associates Center; 🇦🇬 St. John's, Antigua and Barbuda

Athens Beverly Hills Medical Group; 🇬🇷 Glyfáda, Athens, Greece