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NCT03180463
The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ONFH)
Phase 1, PHASE2 trial testing Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) in Osteonecrosis of Femoral Head in 30 participants. Suspended.
30 June 2026
Quick facts
| Lead sponsor | Sclnow Biotechnology Co., Ltd. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 31 December 2025 |
| Primary completion | 30 June 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) — full drug profile →
- core decompression
Conditions studied
- Osteonecrosis of Femoral Head — all drugs for Osteonecrosis of Femoral Head →
Sponsor
Sclnow Biotechnology Co., Ltd. — full company profile →
Who can join
Eligibility, any sex, with Osteonecrosis of Femoral Head. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating osteonecrosis of femoral head patients.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Fresh Umbilical Cord Blood-A Source of Multipotent Stem Cells, Collection, Banking, Cryopreservation, and Ethical Concerns.
Devi S, Bongale AM, Tefera MA, Dixit P, et al · · 2023 · cited 17× · PMID 37763198 · DOI 10.3390/life13091794 -
Bioengineering strategies targeting angiogenesis: Innovative solutions for osteonecrosis of the femoral head.
Zhu W, Xu Z, Zhou D, Xu J, et al · · 2025 · cited 4× · PMID 39866964 · DOI 10.1177/20417314241310541
Verify or expand the search:
- PubMed search for NCT03180463
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
Trials testing the same drug.
- NCT03186456 — The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ACI) in the Treatment of Acute Cereb · Phase 1 · suspended
- NCT03180450 — The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF) · Phase 1, PHASE2 · suspended
Other Sclnow Biotechnology Co., Ltd. trials
Trials by the same sponsor.
- NCT03186456 — The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ACI) in the Treatment of Acute Cereb · Phase 1 · suspended
- NCT06589271 — SCLife®-LDD hUC-MSCs Injection Therapy for Patients With Lumbar Intervertebral Disc Degeneration · Phase 1 · suspended
- NCT03378414 — Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-SA) for Patients With Spinocerebellar Ataxia · Phase 2 · not yet recruiting
- NCT06503471 — SCLife®-UT hUC-MSCs Advanced Therapy Medicinal Products (hUC-MSCs ATMPs) for Patients With Thin Endometrial Infertility · Phase 1 · suspended
- NCT03184935 — Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome · Phase 1, PHASE2 · suspended
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 NCT03180463 (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 Sclnow Biotechnology Co., Ltd.
- Last refreshed: 14 May 2025
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/NCT03180463.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing