Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarie Hudson, MD
About this trial
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
Qualifiers
SSc according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2103 classification criteria for systemic sclerosis
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
Ineligibility or unwillingness to undergo autologous hematopoietic stem cell transplant
Disqualifiers
Age < 18 years
Pregnancy or unwillingness to use adequate contraception
FVC < 45% and/or DLCO (corrected for hemoglobin) < 30% predicted;
Left ventricular ejection fraction < 40% by cardiac echocardiography;
Trial design
Treatments tested in this trial
- UCMSC
- Placebo
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
Marie Hudson, MD
Lead sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Sponsor institution
Medical University of South Carolina
Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Université de Montréal
Collaborator
Assistance Publique - Hôpitaux de Paris
Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator
University Paris 7 - Denis Diderot
Collaborator
Source ClinicalTrials.gov