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Repair Effect and Safety Evaluation of Autologous Adipose-Derived Cell Spheres Combined with Core Decompression for Early-Stage Osteonecrosis of the Femoral Head: A Multicenter Clinical Study

Repair Effect and Safety Evaluation of Autologous Adipose-Derived Cell Spheres Combined with Core Decompression for Early-Stage Osteonecrosis of the Femoral Head: A Multicenter Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127471
Enrollment
Unknown
Registered
2026-07-01
Start date
2026-07-10
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteonecrosis of the Femoral Head

Interventions

Control group:Core Decompression of the Femoral Head
Experimental group:Standard core decompression + autologous fat-derived cell sphere implantation

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18 to 65 years old, gender not limited. 2. It meets the diagnostic criteria of the "Clinical Diagnosis and Treatment Guidelines for Adult Femoral Head Necrosis in China (2020)" and is confirmed by MRI. 3. According to the 2019 ARCO staging standard, it is divided into Stage I and Stage II. 4. The Japanese Osteonecrosis Investigation Committee classifies it as type B, C1 or C2. 5. Have the willingness to undergo hip-preserving treatment, understand and voluntarily sign the informed consent form, and be able to cooperate with the treatment and follow-up.

Exclusion criteria

Exclusion criteria: 1.ARCO stage IV or already accompanied by severe osteoarthritis. 2. There is active infection locally or throughout the body. 3. Currently receiving systemic corticosteroid hormone treatment. 4. The affected hip has undergone other hip-preserving surgeries within one year. 5. Pregnant women, lactating women or those planning to become pregnant. 6. Suffering from severe mental illness or cognitive impairment. 7. Active stage of autoimmune diseases. 8. Active hepatitis B, hepatitis C or HIV infection. 9. Unable or unwilling to accept long-term (recommended for more than one year) walking with crutches after the operation. 10. Any other circumstances that the researcher deems unsuitable for participation in this study

Design outcomes

Primary

MeasureTime frame
Collapse progression r;Changes in the degree of femoral head collapse;

Secondary

MeasureTime frame
Harris Hip Score;Visual Analogue Scale;Femoral head necrosis repair rate;

Countries

China

Contacts

Public ContactPeng Jiang

Chinese PLA General Hospital

pengjiang301@126.com+86 139 1006 0749

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026