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

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Osteoarthritis

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05147675

Enrollment

Registered

2021-12-07

Start date

2022-12-01

Completion date

2027-12-01

Last updated

2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Spinal Arthritis

Keywords

Osteoarthritis, stem cell treatment, Spinal Arthritis

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.

Interventions

BIOLOGICALAlloRx

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Safety (adverse events)	Four year follow-up	Clinical monitoring of possible adverse events or complications

Secondary

Measure	Time frame	Description
Efficacy: Single Assessment Numeric Evaluation Score (SANE)	Four year follow-up	ranging from 0 to 100%

Countries

Antigua and Barbuda, Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026