drugset / Trial / NCT07535931
Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Systemic Sclerosis
Phase 1/2
Not yet recruiting
21 enrolled
Shenzhen Huishan Biotechnology Co., Ltd.
Southern Medical University, China · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The goal of this clinical trial is to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection(HS\_SW01 Cells injection) in patients with systemic sclerosis, and to further explore its pharmacokinetics(PK), immunological profile and preliminary efficacy. Participants will be required to sign the informed consent form and will only be assigned to the study and enrolled after undergoing a series of tests and meeting the inclusion and exclusion criteria of the protocol.
Timeline
- Start
- 2026-04-10
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HS_SW01 cells injection | Unknown | 0.5 cells/kg | Intravenous |
| Subject | HS_SW01 cells injection | Unknown | 1 cells/kg | Intravenous |
| Subject | HS_SW01 cells injection | Unknown | 2 cells/kg | Intravenous |