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

Phase 1

Recruiting

• Conditions: Spinal Arthritis; Osteoarthritis
• Interventions: Biological: AlloRx

• Registration Number: NCT05147675
• Lead Sponsor: The Foundation for Orthopaedics and Regenerative Medicine

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-07
• Study Start: 2022-12-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-10
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group (AlloRx)	AlloRx	Intravenous infusion and intraarticular injection (total dose 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: Single Assessment Numeric Evaluation Score (SANE)	Four year follow-up	ranging from 0 to 100%

Trial Locations

Locations (2)

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

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