Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells… (NCT07101562) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Avascular Necrosis of Femur Head
China30 participantsStarted 2026-04-20
Plain-language summary
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.
Who can participate
Age range20 Years – 65 Years
SexALL
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Inclusion criteria
✓. Capable of understanding and voluntarily signing the informed consent form before the study;
✓. Meets the diagnostic criteria in the "Clinical Diagnosis and Treatment Guidelines for Adult Femoral Head Necrosis in China (2020)";
✓. Age range: 20 - 65 years old (inclusive of boundary values), gender not restricted;
✓. Staged as ARCO II stage;
✓. Non-traumatic femoral head necrosis;
✓. Has received conservative treatment (such as physical therapy, blood-activating, analgesic drugs, etc.) for more than 2 weeks, and the target hip joint still shows persistent pain symptoms;
✓. The subjects are usually able to move, not bedridden or in a wheelchair for a long time, and can walk more than 50 meters without the help of crutches or walking sticks;
✓. During the trial period and within 90 days after the surgery, the subjects have no pregnancy plans and voluntarily take effective contraceptive measures.
Exclusion criteria
✕. Based on the researcher's judgment, the subjects had a history of trauma and the injury affected the target hip joint;
✕. In the six months prior to screening, there were obvious injuries involving the target hip joint;
✕. The subject's femoral head necrosis was due to other diseases affecting the hip joint (such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis, symptomatic cartilage calcification, bone necrosis, active infection), or according to the researcher's judgment, peripheral or central nervous system lesions that might affect the assessment of pain and function of the target hip joint (such as back pain, knee joint disease, intervertebral disc protrusion, sciatic nerve pain, fibromyalgia, diabetic neuropathy, etc.);
What they're measuring
1
To verify the effectiveness of tissue-engineered bone in the treatment of early femoral head necrosis
Timeframe: 1 month, 2 months, 3 months, 6 months and one year after the operation
2
To verify the effectiveness of tissue-engineered bone in the treatment of early femoral head necrosis
Timeframe: Before the operation, 1 month, 6 months and 1 year after the operation
3
To verify the effectiveness of tissue-engineered bone in the treatment of early femoral head necrosis
Timeframe: Before the operation, 6 months after the operation and 1 year after the operation
Trial details
NCT IDNCT07101562
SponsorThe First Affiliated Hospital of Xinxiang Medical College
✕. The femoral head of the target hip joint had obvious necrosis, collapse, joint fusion, etc.;
✕. Those who had a history of hip joint replacement, arthroplasty, or other hip joint surgeries, or planned to undergo surgical treatment of any lower limb/hip joint during the study period;
✕. The target hip joint had suppurative arthritis or a previous history;
✕. The target hip joint had obvious joint effusion;
✕. During the screening period, the target hip joint had active joint infection or skin ulceration, infection in the surgical area, or any significant chronic skin disease that might interfere with the surgical procedure;