Actively Recruiting
Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis
Led by Marie Hudson, MD · Updated on 2026-02-03
18
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
Sponsors
M
Marie Hudson, MD
Lead Sponsor
M
Medical University of South Carolina
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test the safety and efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UCMSC) for the treatment of Systemic Sclerosis (SSc).
CONDITIONS
Official Title
Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with systemic sclerosis according to ACR/EULAR 2013 criteria
- Severe disease defined by either disease duration ≤ 2 years with modified Rodnan skin score (mRss) > 20 and elevated ESR or low hemoglobin due to SSc
- Or mRss > 15 with at least one major organ involvement attributed to SSc: lung, kidney, or heart
- Inadequate response or adverse events requiring stopping standard therapy including methotrexate and/or mycophenolate mofetil for at least 3 months
- Ineligible or unwilling to undergo autologous hematopoietic stem cell transplant
You will not qualify if you...
- Under 18 years of age
- Pregnant or unwilling to use adequate contraception
- Life-threatening organ damage including severe lung, heart, or kidney dysfunction
- Liver failure with elevated liver enzymes unless related to disease activity
- Active cancers or myelodysplasia
- Uncontrolled high blood pressure
- Active or high risk of infections including HIV, HTLV, hepatitis B or C
- Significant malnutrition with body mass index below 18 kg/m2
- Severe psychiatric disorders
- Bone marrow insufficiency with low blood cell counts not due to SSc
- History of poor study compliance
- Enrolled in another investigational drug trial
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
Research Team
M
Marie Hudson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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