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

Last updated: April 4, 2025
Sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Overall Status: Active - Recruiting

Phase

1

Condition

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Arthritis And Arthritic Pain

Treatment

AlloRx

Clinical Study ID

NCT05003934
SC-8-ATG-10-03
  • All Genders

Study 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 Rheumatoid Arthritis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Rheumatoid Arthritis

  • Understanding and willingness to sign a written informed consent document

Exclusion

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) compromisepatient's safety.

  • Continued drug abuse

  • Pre-menopausal women not using contraception

  • Previous organ transplant

  • Hypersensitivity to sulfur

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: AlloRx
Phase: 1
Study Start date:
November 07, 2021
Estimated Completion Date:
September 30, 2026

Study Description

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Rheumatoid Arthritis (RA). Patients with RA will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. 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.

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

Connect with a study center

  • Medical Surgical Associates Center

    St. John's,
    Antigua and Barbuda

    Active - Recruiting

  • Center for Investigation in Tissue Engineering and Cellular Therapy

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Medyca Bosques

    San Pedro Garza García, N.L
    Mexico

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.