Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for MS

Phase 1

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Biological: AlloRx

• Registration Number: NCT05003388
• Lead Sponsor: The Foundation for Orthopaedics and Regenerative Medicine

Brief Summary

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of multiple sclerosis

Detailed Description

Multiple Sclerosis (MS) can be a devastating disease. There is evidence that mesenchymal stem cell treatment is safe and efficacious for the treatment of MS. Patients with MS will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The dose for the infusion 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.

For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis

Study Timeline

• Study Start: 2021-06-26
• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

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

Inclusion Criteria

• Diagnosis of Multiple Sclerosis
• 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	Single intravenous infusion 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: Kurtzke Expanded Disability Status Scale (EDSS)	Four year follow-up	EDSS is a scale to evaluate the function of the central nervous system. It will be completed for each follow up point

Trial Locations

Locations (2)

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

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