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RecruitingNCT05003934Updated Apr 8, 2025

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

A Phase 1 interventional study of AlloRx in Rheumatoid Arthritis, sponsored by The Foundation for Orthopaedics and Regenerative Medicine. Recruiting at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by The Foundation for Orthopaedics and Regenerative Medicine · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2021; still recruiting 4 years 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Sex
All
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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

Read the detailed 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

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Conditions studied

  • Rheumatoid Arthritis
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 20 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

The Foundation for Orthopaedics and Regenerative Medicine is the lead sponsor of 33 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    Single intravenous infusion of 100 million cells

    Biological: AlloRx

Interventions

  • BiologicalAlloRx

    cultured allogeneic adult umbilical cord derived mesenchymal stem cells

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What researchers measure

Primary outcomes

  1. Safety (adverse events)

    Clinical monitoring of possible adverse events or complications

    Time frame: Four year follow-up

Secondary outcomes

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

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

    Time frame: Four year follow-up

  2. Efficacy: visual analog scale (VAS)

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

    Time frame: Four year follow-up

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Study locations

2 of 2 sites recruiting
  • Medical Surgical Associates Center
    St. John's, Antigua and Barbuda
    Recruiting
  • Center for Investigation in Tissue Engineering and Cellular Therapy
    Buenos Aires, Argentina
    Recruiting
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References and documents

Publications

  • 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. PubMed 18490431 ↗
  • 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. PubMed 30211382 ↗
  • 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. PubMed 31908418 ↗
  • 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. PubMed 30551438 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05003934
Lead sponsor
The Foundation for Orthopaedics and Regenerative Medicine
Responsible party
Sponsor
First posted
Aug 13, 2021
Start date
Nov 7, 2021
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Apr 8, 2025

Study contacts

Chadwick Prodromos, MD
principal investigator · The Foundation for Orthopaedics and Regenerative Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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