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

The Foundation for Orthopaedics and Regenerative Medicine

Status and phase

Enrolling

Phase 1

Conditions

Spinal Arthritis

Osteoarthritis

Treatments

Biological: AlloRx

Study type

Interventional

Funder types

Other

Identifiers

NCT05147675

ATG-1-MSC-011

Details and patient eligibility

About

This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously and intraarticularly for the treatment of Osteoarthritis.

Full description

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Osteoarthritis (OA). This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of OA. Patients with OA will receive intravenous infusion and intraarticular injection of UC-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

92 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of Osteoarthritis
Understanding and willingness to sign a written informed consent document

Exclusion criteria

Active infection
Active cancer
Chronic multisystem organ failure
Pregnancy
Clinically significant Abnormalities on pre-treatment laboratory evaluation
Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
Continued drug abuse
Pre-menopausal women not using contraception
Previous organ transplant
Hypersensitivity to sulfur