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SuspendedPhase 1/2
The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ONFH)
Key facts
- Who runs it
- Sclnow Biotechnology Co., Ltd.
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Suspended
- Phase
- Phase 1/2
- People taking part
- 30 people, planned
- Starts
- 31 Dec 2026
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
- core decompression
- Record updated
- 23 April 2026
- Why it stopped
- Others
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Ficat classification is I, IIa, or IIb period
- no obvious improvement or ingravescence by conservative treatment
- patients or their statutory receive human umbilical cord mesenchymal stem cell of their own will, and signed informed consent form
Who cannot take part
- under other therapy that possibly influence MSC security or efficacy
- acute, chronic infection patients
- combined with heart, lung, kidney disease, and cannot tolerate operation
- HIV positive
- Ficat classification is third or fourth period
- ankylosing spondylitis patient
- acetabular dysplasia patient
- with tumor
- clinical data deficient
- pregnancy or breast feeding women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Group 1Treatment being tested
Core decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#).
Treatment: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) and core decompression
- Group 2Placebo, for comparison
Core decompression surgery.
Treatment: core decompression
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
- Record updated
- 23 April 2026