The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ONFH)
NCT03180463 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-04-23
Summary
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.
Conditions
- Osteonecrosis of Femoral Head
Interventions
- DRUG
-
Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) will be injected through surgery tunnel, 2\*10\^7 cells,
- PROCEDURE
-
core decompression
The surgery will drill into the femoral neck (hip bone) and through the necrotic area of the bone that died from the lack of blood flow, take out partial osseous tissue.
Sponsors & Collaborators
-
Sclnow Biotechnology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Bahushan · Inner Mongolia International Mongolian Hospital
-
Lei Guo, Dr. · China-Japan Union Hospital, Jilin University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-12-31
- Primary Completion
- 2027-06-30
- Completion
- 2027-12-31
Countries
- China
Study Locations
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