drugset / Trial / NCT04356287
Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis
Phase 1/2
Recruiting
18 enrolled
Marie Hudson, MD
Assistance Publique - Hôpitaux de Paris · collabCentre hospitalier de l'Université de Montréal (CHUM) · collabMcGill University Health Centre/Research Institute of the McGill University Health Centre · collabMedical University of South Carolina · collabUniversity Paris 7 - Denis Diderot · collabUniversité de Montréal · collab
RandomizedParallel-groupQuadruple-blindTreatment
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).
Timeline
- Start
- 2023-01-05
- Primary completion
- 2026-12
- Completion
- 2027-12
Publications
- Background Wang D, Zhang H, Liang J, Wang H, Hua B, Feng X, Gilkeson GS, Farge D, Shi S, Sun L. A Long-Term Follow-Up Study of Allogeneic Mesenchymal Stem/Stromal Cell Transplantation in Patients with Drug-Resistant Systemic Lupus Erythematosus. Stem Cell Reports. 2018 Mar 13;10(3):933-941. doi: 10.1016/j.stemcr.2018.01.029. Epub 2018 Mar 1.
- Background Liang J, Zhang H, Kong W, Deng W, Wang D, Feng X, Zhao C, Hua B, Wang H, Sun L. Safety analysis in patients with autoimmune disease receiving allogeneic mesenchymal stem cells infusion: a long-term retrospective study. Stem Cell Res Ther. 2018 Nov 14;9(1):312. doi: 10.1186/s13287-018-1053-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | human umbilical cord mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intravenous |