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NCT06058091
RY_SW01 Cell Injection Therapy in Systemic Sclerosis
Phase 1, PHASE2 trial testing RY_SW01 cell injection in Systemic Sclerosis in 81 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Jiangsu Renocell Biotech Company |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 81 |
| Start date | 22 September 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2035 |
| Sites | 1 location across China |
Drugs / interventions tested
- RY_SW01 cell injection — full drug profile →
- Basic treatment — full drug profile →
Conditions studied
- Systemic Sclerosis — all drugs for Systemic Sclerosis →
Sponsor
Jiangsu Renocell Biotech Company — full company profile →
Who can join
Adults 18 to 65, any sex, with Systemic Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Systemic sclerosis (SSc) tends to progress to involve multiple vital organs within 5 years of diagnosis, significantly impacting patient prognosis and survival. Clinical indications suggest that early intervention is more favorable for long-term outcomes in patients. Although guidelines recommend various drugs for symptomatic treatment, there is currently no standard therapy or effective medication to slow the progression of the disease. Therefore, for patients with diffuse SSc, as defined by a skin score of 10≤mRSS≤30 points, who have been treated with at least two therapies, including steroids, immunosuppressive agents, biologics, etc., within 5 years of diagnosis, the applicant intends to develop a drug that can both modulate the immune system and counteract fibrosis. The goal is to provide long-term benefits to patients through early intervention.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Consecutive intrabronchial administration of Wharton's jelly-derived mesenchymal stromal cells in ECMO-supported pediatric patients with end-stage interstitial lung disease: a safety and feasibility study (CIBA method).
Dominguez-Pinilla N, González-Granado LI, Gonzaga A, López Diaz M, et al · · 2025 · cited 3× · PMID 40188166 · DOI 10.1186/s13287-025-04289-3
Verify or expand the search:
- PubMed search for NCT06058091
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of RY_SW01 cell injection
Trials testing the same drug.
- NCT06058078 — RY_SW01 Cell Injection Therapy in Active Lupus Nephritis · Phase 2 · recruiting
Other recruiting trials for Systemic Sclerosis
Currently open trials in the same condition.
- NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu · Phase 3 · recruiting
- NCT06947473 — Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH. · Phase 1, PHASE2 · recruiting
- NCT07047690 — A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis · Phase 2 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07295847 — A Study of AZD0120 in Autoimmune Diseases · Phase 1 · recruiting
Other Jiangsu Renocell Biotech Company trials
Trials by the same sponsor.
- NCT06489652 — 89Zr-Oxine-RY_SW01 Cell Injection for the Treatment of Systemic Sclerosis · Phase 1 · not yet recruiting
- NCT06058078 — RY_SW01 Cell Injection Therapy in Active Lupus Nephritis · Phase 2 · 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 NCT06058091 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu Renocell Biotech Company
- Last refreshed: 18 January 2024
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/NCT06058091.
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