Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Lupus
1 other identifier
interventional
15
2 countries
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 Lupus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2025
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2021
CompletedFirst Posted
Study publicly available on registry
August 24, 2021
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
April 8, 2025
April 1, 2025
2.8 years
August 20, 2021
April 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety (adverse events)
Clinical monitoring of possible adverse events or complications
Four year follow-up
Study Arms (1)
Treatment Group (AlloRx)
EXPERIMENTALSingle intravenous infusion of 100 million cells
Interventions
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Eligibility Criteria
You may qualify if:
- Diagnosis of Lupus
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Medical Surgical Associates Center
St John's, Antigua and Barbuda
Athens Beverly Hills Medical Group
Glyfada, Athens, 16675, Greece
Related Publications (3)
Wang D, Li J, Zhang Y, Zhang M, Chen J, Li X, Hu X, Jiang S, Shi S, Sun L. Umbilical cord mesenchymal stem cell transplantation in active and refractory systemic lupus erythematosus: a multicenter clinical study. Arthritis Res Ther. 2014 Mar 25;16(2):R79. doi: 10.1186/ar4520.
PMID: 24661633BACKGROUNDWang D, Zhang H, Liang J, Li X, Feng X, Wang H, Hua B, Liu B, Lu L, Gilkeson GS, Silver RM, Chen W, Shi S, Sun L. Allogeneic mesenchymal stem cell transplantation in severe and refractory systemic lupus erythematosus: 4 years of experience. Cell Transplant. 2013;22(12):2267-77. doi: 10.3727/096368911X582769c.
PMID: 24388428BACKGROUNDSun L, Wang D, Liang J, Zhang H, Feng X, Wang H, Hua B, Liu B, Ye S, Hu X, Xu W, Zeng X, Hou Y, Gilkeson GS, Silver RM, Lu L, Shi S. Umbilical cord mesenchymal stem cell transplantation in severe and refractory systemic lupus erythematosus. Arthritis Rheum. 2010 Aug;62(8):2467-75. doi: 10.1002/art.27548.
PMID: 20506343BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Chadwick Prodromos, MD
The Foundation for Orthopaedics and Regenerative Medicine
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 20, 2021
First Posted
August 24, 2021
Study Start
December 1, 2025
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
April 8, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share