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A single center, single group clinical research trial evaluating the safety and effectiveness of decellularized articular cartilage repair for knee cartilage injury repair with target values

A single center, single group clinical research trial evaluating the safety and effectiveness of decellularized articular cartilage repair for knee cartilage injury repair with target values

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094194
Enrollment
Unknown
Registered
2024-12-18
Start date
2022-10-12
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

articular cartilage injury

Interventions

Sponsors

Xi’an Honghui Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1) Gender not limited, aged 18-55, in good physical condition, able to tolerate surgery; 2) According to the Outerbridge criteria for injury diagnosis, cartilage injuries are classified as grade III and IV; 3) MRI evaluation shows that the patient has a large area (1-4cm ²) of cartilage defect, 4) No obvious joint degeneration or extra articular deformities; 5) Informed consent: Participants must have the ability to understand and voluntarily sign written informed consent, comply with the research protocol and visit procedures;

Exclusion criteria

Exclusion criteria: 1) Patients with stage three or more knee osteoarthritis, inversion angle exceeding 10 degrees, or bilateral ventricular lesions; 2) MRI indicates severe subchondral bone injury combined with severe ipsilateral meniscus injury, requiring complete meniscectomy; 3) Allergic constitution, such as a history of autoimmune diseases or family history; 4) Patients who have received bone marrow mesenchymal stem cell transplantation for cartilage defects in the affected knee joint within 12 months before surgery, or He underwent cartilage regeneration surgery; 5) Knee cartilage injury is caused by joint fractures, infections, tumors, and immune diseases; 6) Systemic infection, including HIV, hepatitis B, hepatitis C, human T-cell lymphoma virus and syphilis; 7) Patients with knee joint tumors, rheumatism, rheumatoid arthritis, tuberculosis, suppuration, and complications that affect joint structure; 8) Secondary knee arthritis accompanied by psoriasis, syphilitic neuropathy, and metabolic bone disease; 9) Individuals who frequently use sedatives, sleeping pills, tranquilizers, or other addictive drugs; 10) Patients with severe primary diseases such as cardiovascular, cerebrovascular, hepatic, renal, and hematopoietic systems, as well as psychiatric disorders; 11) Those who cannot accept long-term and complicated rehabilitation training after surgery; 12) Women within 12 months of family planning, breastfeeding, and pregnancy; 13) Patients with special beliefs, sourced from pig sources; 14) Other doctors consider it unsuitable;

Design outcomes

Primary

MeasureTime frame
MR;Lysholm Knee Function Score ;

Secondary

MeasureTime frame
MR;Knee Joint Functional Score (IKDC);Pain score(VAS);Tegner score ;Operational satisfaction;Safety evaluation indicators;

Countries

China

Contacts

Public ContactZheng Jiang

Xi’an Honghui Hospital

597131000@qq.com+86 131 2667 0860

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026