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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of tissue-engineered bone made from commercial decalcified bone scaffolds combined with a patient's own bone marrow mesenchymal stem cells to treat early non-traumatic avascular necrosis of the femoral head. This condition progresses quickly, often leading to femoral head collapse within 1 to 4 years. Early intervention aims to preserve the femoral head and improve outcomes compared to current treatments like core decompression and bone grafting, which have limitations including donor site damage and limited biological activity. The study uses tissue engineering to create a composite of seed cells, growth factors, and scaffold materials that are transplanted to the bone defect site. This method provides structural support and promotes bone and blood vessel regeneration. The intervention involves using tissue-engineered bone with autologous bone marrow mesenchymal stem cells for femoral head repair. The treatment is applied during surgery, and the study will monitor its effects over time to assess clinical benefits and safety. Participants will be assessed before surgery and followed up at multiple time points including 1 month, 2 months, 3 months, 6 months, and one year after the operation. Evaluations will include effectiveness measures of the tissue-engineered bone in treating femoral head necrosis and safety monitoring. The study involves clinical examinations, imaging, and other tests to track bone repair and function. The total participation duration for each patient spans at least one year after surgery to observe long-term outcomes.
CONDITIONS
Brief 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 informed consent before the study
- Meets diagnostic criteria for adult femoral head necrosis per Chinese guidelines (2020)
- Age between 20 and 65 years, any gender
- ARCO stage II femoral head necrosis
- Non-traumatic femoral head necrosis
- Received conservative treatment for more than 2 weeks with persistent hip pain
- 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 90 days after surgery
You will not qualify if you...
- History of trauma affecting the target hip joint
- Recent injuries to the target hip joint within 6 months before screening
- Femoral head necrosis caused by other diseases or conditions affecting pain/function assessment
- Obvious necrosis, collapse, or joint fusion of the femoral head
- History or planned hip joint replacement or surgery during study period
- Suppurative arthritis or past infection in the target hip joint
- Joint effusion or active infection in the target hip joint at screening
- Use of opioids or glucocorticoids 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 certain blood circulation or anticoagulant drugs within 8 weeks before screening unless stable
- Need for systemic glucocorticoid treatment
- Abnormal liver or kidney function beyond specified limits
- Active or recent malignant tumors or cancer history within 5 years
- Significant ECG abnormalities
- Serious cardiovascular diseases or uncontrolled hypertension
- Positive tests for hepatitis B, hepatitis C, AIDS, or syphilis
- Allergies to study drug ingredients
- History of gastrointestinal bleeding or active ulcers
- Unable to avoid new heavy physical activities
- History of mental disorders or substance abuse
- Alcohol or drug abuse
- Pregnant, breastfeeding, or unwilling to use contraception
- Participation in other clinical trials within 3 months
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single operation with immediate post-operative care
Participants receive tissue-engineered bone with autologous bone marrow mesenchymal stem cells to repair avascular necrosis of the femoral head after the surgical removal of necrotic bone tissue.
1 surgical visit and immediate post-operative monitoring
Duration - 1 year after the operation
Participants are monitored to assess the effectiveness and safety of the tissue-engineered bone in repairing early femoral head necrosis.
Visits at 1 month, 2 months, 3 months, 6 months, and 1 year after surgery
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
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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