NCT04356287 Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis
| NCT ID | NCT04356287 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Marie Hudson, MD |
| Condition | Sclerosis, Systemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2023-01-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2023-01-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. SSc according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2103 classification criteria for systemic sclerosis 2. Severe disease defined as: i) disease duration of 2 years or less with an mRss of \> 20 and (ESR \> 25 mm and/or hemoglobin \< 11 g/dL, not explained by other causes than SSc), or ii) mRss \>15 without any restriction as to disease duration plus at least one major organ involvement as defined by: a) respiratory involvement consisting of lung diffusion capacity for carbon monoxide (DLCO) and/or forced vital capacity (FVC) \< 80% predicted and evidence of interstitial lung disease (chest X-ray and/or high resolution computed tomography (HRCT) scan); b) renal involvement consisting of past renal crisis and/or stage 2 or 3 chronic kidney disease (glomerular filtration rate between 30-89 mL/min) not explained by other causes than SSc; c) cardiac involvement consisting of reversible congestive heart failure, atrial or ventricular rhythm disturbances such as recurrent episodes of atrial fibrillation or flutter, recurrent atrial paroxysmal tachycardia, conduction abnormalities (2nd or 3rd degree atrioventricular block), and/or mild to moderate pericardial effusion. All causes of organ involvement should be attributed to SSc. 3. Inadequate response (determined by patient and physician judgement) or adverse events necessitating discontinuation of standard therapy (usually consisting of methotrexate 25 mg subcutaneous (or as tolerated) per week and/or mycophenolate mofetil 2-3 gm/d (or as tolerated) for at least 3 months 4. Ineligibility or unwillingness to undergo autologous hematopoietic stem cell transplant Exclusion Criteria: 1. Age \< 18 years 2. Pregnancy or unwillingness to use adequate contraception 3. Life-threatening end-organ damage defined as: * FVC \< 45% and/or DLCO (corrected for hemoglobin) \< 30% predicted; * Left ventricular ejection fraction \< 40% by cardiac echocardiography; * Pulmonary hypertension with baseline resting systolic pulmonary arterial pressures \> 50 mmHg by cardiac echocardiography, or mean pulmonary artery pressure \> 25 mmHg (and pulmonary wedge pressure \< 15 mmHg) on right heart catheterization; * stage 4 or more chronic kidney disease (glomerular filtration rate \< 30 ml/min) 4. Liver failure defined as an abnormal transaminase level (aspartate aminotransferase (ASAT), alanine aminotransaminase (ALAT) \> 3 normal) unless related to activity of the disease 5. Concurrent neoplasms or myelodysplasia 6. Uncontrolled hypertension 7. Uncontrolled acute or chronic infection (HIV, HTLV-1/2 (Human T-lymphotropic virus), hepatitis B surface Ag positive, hepatitis C positive) or high risk thereof 8. Significant malnutrition with BMI \< 18 kg/m2 9. Severe concomitant psychiatric disorder 10. Bone marrow insufficiency defined as neutropenia \< 0.5 x 109 cell/L, thrombocytopenia \< 30 x 109 cell/L, anemia \< 8g/dL, CD4+ T lymphopenia \< 200 x 106 cell/L due to other diseases than SSc (CD4 - cluster of differentiation 4) 11. History of poor compliance 12. Concurrent enrolment in any other protocol using an investigational drug 13. Inability to provide informed consent
Contact & Investigator
Marie Hudson, MD
PRINCIPAL INVESTIGATOR
Sir Mortimer B. Davis - Jewish General Hospital
Frequently Asked Questions
Who can join the NCT04356287 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sclerosis, Systemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04356287 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04356287 currently recruiting?
Yes, NCT04356287 is actively recruiting participants. Contact the research team at marie.hudson@mcgill.ca for enrollment information.
Where is the NCT04356287 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT04356287 clinical trial?
NCT04356287 is sponsored by Marie Hudson, MD. The principal investigator is Marie Hudson, MD at Sir Mortimer B. Davis - Jewish General Hospital. The trial plans to enroll 18 participants.