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NCT Number: NCT05003934

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical Surgical Associates Center, St John's, Antigua and Barbuda

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Rheumatoid Arthritis
  • 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

Treatment and study plan

AlloRx

Biological

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Primary outcomes

  1. Safety (adverse events)

    Time frame: Four year follow-up

    Clinical monitoring of possible adverse events or complications

Secondary outcomes

  1. Efficacy: the 28-joint disease activity score (DAS 28)

    Time frame: Four year follow-up

    DAS 28 is used to determine the disease activity for RA. It will be completed for each follow up point.

  2. Efficacy: visual analog scale (VAS)

    Time frame: Four year follow-up

    VAS is a scale that is used to measure pain. It will be completed for each follow up point.

Sponsors and collaborators

Lead sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Other

Registry information

Official study title

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Rheumatoid Arthritis

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2021
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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