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

NCT05003934 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SC-8-ATG-10-03
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

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 Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Safety (adverse events)

  Clinical monitoring of possible adverse events or complications

  Four year follow-up

Secondary Outcomes (2)

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

  Four year follow-up

• Efficacy: visual analog scale (VAS)

  Four year follow-up

Study Arms (1)

Treatment Group

EXPERIMENTAL

Single intravenous infusion of 100 million cells

Biological: AlloRx

Interventions

AlloRx BIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Treatment Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Rheumatoid Arthritis
• Understanding and willingness to sign a written informed consent document

You may not qualify if:

• 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

Sponsors & Collaborators

• The Foundation for Orthopaedics and Regenerative Medicine: lead

Study Sites (2)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

RECRUITING

Center for Investigation in Tissue Engineering and Cellular Therapy

Buenos Aires, Argentina

RECRUITING

Related Publications (4)

• Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, Aletaha D, van Riel PL. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009 Jun;68(6):954-60. doi: 10.1136/ard.2007.084459. Epub 2008 May 19.

  PMID: 18490431 BACKGROUND

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 BACKGROUND

• Wang L, Huang S, Li S, Li M, Shi J, Bai W, Wang Q, Zheng L, Liu Y. Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cell Therapy for Rheumatoid Arthritis Patients: A Prospective Phase I/II Study. Drug Des Devel Ther. 2019 Dec 19;13:4331-4340. doi: 10.2147/DDDT.S225613. eCollection 2019.

  PMID: 31908418 BACKGROUND

• Ghoryani M, Shariati-Sarabi Z, Tavakkol-Afshari J, Ghasemi A, Poursamimi J, Mohammadi M. Amelioration of clinical symptoms of patients with refractory rheumatoid arthritis following treatment with autologous bone marrow-derived mesenchymal stem cells: A successful clinical trial in Iran. Biomed Pharmacother. 2019 Jan;109:1834-1840. doi: 10.1016/j.biopha.2018.11.056. Epub 2018 Nov 26.

  PMID: 30551438 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Chadwick Prodromos, MD

  The Foundation for Orthopaedics and Regenerative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 13, 2021
• Study Start: November 7, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

AR (1); AN (1)