Actively Recruiting
Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Avascular Necrosis of Femur Head
Led by The First Affiliated Hospital of Xinxiang Medical College · Updated on 2026-05-04
30
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The commercial decalcified bone scaffold combined with the patient's autologous bone marrow mesenchymal stem cells was used for in vitro culture to form tissue-engineered bone, and the effect of this tissue-engineered bone in early non-traumatic femoral head necrosis was explored.
CONDITIONS
Official Title
Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Avascular Necrosis of Femur Head
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the informed consent form
- Diagnosed according to the Clinical Diagnosis and Treatment Guidelines for Adult Femoral Head Necrosis in China (2020)
- Aged between 20 and 65 years, any gender
- Stage ARCO II of femoral head necrosis
- Non-traumatic femoral head necrosis
- Received conservative treatment for over 2 weeks but still has persistent hip pain
- Usually able to walk more than 50 meters without crutches or walking sticks
- No pregnancy plans and willing to use effective contraception during the trial and for 90 days after surgery
You will not qualify if you...
- History of trauma affecting the target hip joint
- Obvious injury to the target hip joint within 6 months prior to screening
- Femoral head necrosis caused by other diseases affecting the hip joint or nervous system conditions affecting pain and function assessment
- Target hip joint with obvious necrosis, collapse, or joint fusion
- History or planned hip joint surgery during the study period
- Target hip joint with suppurative arthritis or history of it
- Target hip joint with obvious joint effusion
- Active joint infection, skin ulceration, or chronic skin disease in the surgical area during screening
- Use of opioids or glucocorticoids for the target hip joint within 30 days before screening or planned long-term use
- Drug injection or surgical treatment in the hip joint within 6 months before treatment
- Use of cilostazol or similar drugs for blood circulation or anticoagulation started less than 8 weeks before screening
- Disease requiring systemic glucocorticoid treatment
- Abnormal liver or kidney function at screening
- Active malignant tumor or cancer diagnosis within 5 years
- Significant ECG abnormalities before enrollment
- Recent serious cardiovascular events or unstable heart conditions
- Uncontrolled hypertension despite treatment
- Positive tests for hepatitis B, hepatitis C, AIDS, or syphilis
- Known or suspected allergy to study drugs
- History of gastrointestinal bleeding or active ulcers related to NSAIDs
- Allergy or hypersensitivity to the study drug
- Unable to avoid new non-habitual physical activities
- History of mental disorder or substance abuse
- Alcohol or drug abuse or mental disorders
- Pregnant or lactating women and women of childbearing age not using approved contraception; men unwilling to use approved contraception
- Participation in other clinical trials within 3 months before screening
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China, 453000
Actively Recruiting
Research Team
W
Wenjie Ren
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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