Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Avascular Necrosis of Femur Head

NCT07101562 | Recruiting DMC

• 1 other identifier: TEBANFH-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Avascular Necrosis of Femur Head

Outcome Measures

Primary Outcomes (3)

• To verify the effectiveness of tissue-engineered bone in the treatment of early femoral head necrosis

  The judgment is mainly based on the X-ray plain films and MRI results of the hip joint during the follow-up process: ① Improvement: New bone is generated in the necrotic bone tissue within the femoral head; ② Unchanged: There was no further collapse of the femoral head; ③ Deterioration: Femoral head collapses, osteoarthritis occurs in the femoral head, and total hip replacement arthroplasty (THA) is performed. If the imaging indicates improvement or no change, the imaging is successful; if it indicates deterioration, it is a failure.

  1 month, 2 months, 3 months, 6 months and one year after the operation

• To verify the effectiveness of tissue-engineered bone in the treatment of early femoral head necrosis

  The degree of pain of the patients was evaluated by visual analogue scales (VAS) before the operation, 1 month, 6 months and 1 year after the operation respectively. The VAS pain score standard: A score of 0 to 10, from low to high, indicates an increase in the degree of pain. A score of 0 indicates no pain, and a score of 10 indicates severe and unbearable pain.

  Before the operation, 1 month, 6 months and 1 year after the operation

• To verify the effectiveness of tissue-engineered bone in the treatment of early femoral head necrosis

  The hip joint function of the patients was evaluated by Harris score before the operation, 6 months after the operation and 1 year after the operation respectively. The total score of the Harris score is 100 points, including 44 points for the pain score, 51 points for the functional score (daily activities, walking gait, walking distance, degree of deformity), and 5 points for the range of motion of the hip joint (forward flexion, abduction, external rotation, adduction, internal rotation).

  Before the operation, 6 months after the operation and 1 year after the operation

Secondary Outcomes (1)

• Verify the safety of tissue-engineered bone

  1 month, 2 months, 3 months, 6 months and one year after the operation

Study Arms (1)

Tissue-engineered bone to repair Avascular Necrosis of Femur Head

EXPERIMENTAL

Tissue-engineered bone with autologous bone marrow mesenchymal stem cells to repair Avascular Necrosis of Femur Head

Device: Tissue-engineered bone

Interventions

Tissue-engineered bone DEVICE

Tissue-engineered bone with autologous bone marrow mesenchymal stem cells

Tissue-engineered bone to repair Avascular Necrosis of Femur Head

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.);
• 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;
• The subject was treating the target hip joint, and within 30 days before screening, had used opioids or glucocorticoids for treatment; or was required to use opioids or glucocorticoids for long-term treatment during the study period;
• Patients who had received any drug injection or surgical treatment in the hip joint (both sides or any one side) within 6 months before the treatment start;
• Started using drugs such as cilostazol for promoting blood circulation and anticoagulation therapy 8 weeks before screening;
• Note: If antihypertensive drugs or anticoagulant drugs such as cilostazol were used for treatment for ≥ 8 weeks before screening, they could be used at a stable dose during the study period;
• The subject had a disease requiring systemic glucocorticoid treatment;
• Abnormal liver and kidney function: At the time of screening, AST or ALT \> 2 × upper limits of normal (ULN); or serum creatinine \> 1.5 × ULN, or creatinine clearance rate ≤ 50 mL/min;
• Note: For men, the creatinine clearance rate (mL/min) = \[(140 - age) × weight (kg)\] / \[0.818 × Cr (μmol/L)\]; for women, the creatinine clearance rate (mL/min) = male creatinine clearance rate (mL/min) × 0.85;

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, 453000, China

RECRUITING

MeSH Terms

Conditions

Femur Head Necrosis

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wenjie Ren

CONTACT

8613937354075; 13937354075@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: August 3, 2025
• Study Start: April 20, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2025-07

Locations

CN (1)