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NCT07535931: HS_SW01
A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Systemic Sclerosis
Phase 1, PHASE2 trial testing HS_SW01 cells injection in Systemic Sclerosis (SSc) in 21 participants. Not yet recruiting.
31 December 2027
Quick facts
| Lead sponsor | Shenzhen Huishan Biotechnology Co., Ltd. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 10 April 2026 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2027 |
Drugs / interventions tested
- HS_SW01 cells injection
- HS_SW01 cells injection
- HS_SW01 cells injection
Conditions studied
- Systemic Sclerosis (SSc) — all drugs for Systemic Sclerosis (SSc) →
Sponsor
Shenzhen Huishan Biotechnology Co., Ltd.
Who can join
Adults 18 to 65, any sex, with Systemic Sclerosis (SSc). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07535931
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HS_SW01 cells injection
Trials testing the same drug.
- NCT07534644 — A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Ankylosing Spondylitis · Phase 1, PHASE2 · not yet recruiting
Other recruiting trials for Systemic Sclerosis (SSc)
Currently open trials in the same condition.
- NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
- NCT07087912 — Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases · Phase 4 · recruiting
- NCT07413341 — A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases · Phase 1 · recruiting
- NCT07360808 — Safety and Efficacy of Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis · NA · recruiting
- NCT07292961 — Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach in Children and Adults Diagnosed Wi · NA · recruiting
Other Shenzhen Huishan Biotechnology Co., Ltd. trials
Trials by the same sponsor.
- NCT07534644 — A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Ankylosing Spondylitis · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07535931 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shenzhen Huishan Biotechnology Co., Ltd.
- Last refreshed: 17 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07535931.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing