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A single center, single group clinical trial evaluating the safety and efficacy of joint cartilage repair material (DLHCG) for repairing joint cartilage injuries with target values

A single center, single group clinical trial evaluating the safety and efficacy of joint cartilage repair material (DLHCG) for repairing joint cartilage injuries with target values

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100526
Enrollment
Unknown
Registered
2025-04-10
Start date
2023-06-20
Completion date
Unknown
Last updated
2025-04-14

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

Subei People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1) Gender not limited, aged 15-55 years old, good physical condition, able to tolerate surgery; 2) According to the diagnostic criteria (Diagnostic Criteria for Osteoarthritis, Rheumatology Branch of the Chinese Medical Association, 2021), patients diagnosed with sports or traumatic knee osteoarthritis are clearly defined; 3) MRI evaluation shows that the patient has a cartilage defect with an area of 1-6cm²; 4) No obvious 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) Medial knee joint space stenosis or double compartment disease due to intra-articular deformity; 2) Patients with long-term use of corticosteroids or intra-articular corticosteroid therapy; 3) Severe subchondral bone injury combined with severe ipsilateral meniscus injury requiring total meniscal resection and artificial ligament reconstruction; 4) Allergic constitution, such as previous or family history of autoimmune diseases; 5) Patients who received bone marrow mesenchymal stem cell transplantation for cartilage defect in the affected knee within 12 months before surgery, or other cartilage regeneration surgery; 6) Knee cartilage injury is caused by infection, tumor and immune diseases; 7) Systemic infections, including HIV, hepatitis B, hepatitis C, human T-cell lymphoma virus, and syphilis; 8) Knee tumor, rheumatism, rheumatoid, tuberculosis, suppuration and complications affecting the joint structure, secondary knee arthritis with psoriasis, neurosyphilis, ochronosis, metabolic bone disease, severe osteoporosis; 9) Frequent users of sedatives, hypnotics, sedatives or other addictive drugs; 10) With serious primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mental illness; 11) Those who cannot accept long-term and complicated postoperative rehabilitation training; 12) Women with family planning, lactation or pregnancy within 12 months; 13) Patients with special beliefs, whose source was from pigs; 14) Other doctors deem inappropriate;

Design outcomes

Primary

MeasureTime frame
Magnetic resonance(MR);

Secondary

MeasureTime frame
International Knee Documentation Committee (IKDC);Visual analogue scale(VAS);Operational satisfaction;Safety evaluation indicators;

Countries

China

Contacts

Public ContactFei Wenyong

Subei People's Hospital

597131000@qq.com+86 131 2667 0860

Outcome results

None listed

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