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

The Foundation for Orthopaedics and Regenerative Medicine

Status and phase

Enrolling

Phase 1

Conditions

Spinal Cord Injuries

Treatments

Biological: AlloRx

Biological: autologous adipose derived mesenchymal stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT05018793

SC-8-GR-10-02

Details and patient eligibility

About

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

Full 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.

Enrollment

15 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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