Osteonecrosis of Femoral Head Clinical Trial
Official title:
The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
Verified date | April 2024 |
Source | Sclnow Biotechnology Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 30 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Ficat classification is third or fourth period - acute, chronic infection patients - combined with heart, lung, kidney disease, and cannot tolerate operation - ankylosing spondylitis patient - acetabular dysplasia patient - with tumor - clinical data deficient - HIV positive - pregnancy or breast feeding women - under other therapy that possibly influence MSC security or efficacy |
Country | Name | City | State |
---|---|---|---|
China | Inner Mongolia International Mongolian Hospital | Hohhot | Inner Mongolia |
Lead Sponsor | Collaborator |
---|---|
Sclnow Biotechnology Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRI imageological examination | MRI imageological examination to evaluate the efficient of mesenchymal stem cells. | 6 months | |
Secondary | Harris Hip Score | Evaluate curative effects by the change of Harris hip score. | 6 months |
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