Skip to content

Clinical study on decellularized articular cartilage repair material (DLHCG) for repairing articular cartilage injuries

Clinical study on decellularized articular cartilage repair material (DLHCG) for repairing articular cartilage injuries

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105847
Enrollment
Unknown
Registered
2025-07-11
Start date
2023-01-09
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

articular cartilage injury

Interventions

articular cartilage injury:Surgical implantation method

Sponsors

Yantai Mountain Hospital, Yantai City
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 diagnostic criteria (Diagnostic Criteria for Osteoarthritis, Rheumatology Branch of the Chinese Medical Association, 2021), the diagnosis is confirmed Patients with sports or traumatic osteoarthritis; 3) MRI evaluation shows that the patient has cartilage defects with an area of less than 6cm ², 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) Patients with narrowing of the medial space of the knee joint or bilateral compartment lesions caused by intra-articular deformities; 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 or other cartilage regeneration surgeries in the affected knee joint within 12 months before surgery; 5) Knee cartilage injury is caused by 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, neurosyphilis, brown yellow disease, 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 pigs; 14) Other doctors consider it unsuitable; 15) Arthroscopic examination or surgical procedure reveals an area of articular cartilage defect greater than 6cm2.

Design outcomes

Primary

MeasureTime frame
MR;

Secondary

MeasureTime frame
MR;Knee Joint Functional Score (IKDC(International Knee Documentation Committee));Pain score(VAS);Lysholm Knee Function Score (for the knee);Tegner score (for the knee);AOFAS(American orthopedic foot and ankle society) ankle;Operational satisfaction;Safety evaluation indicators;

Countries

China

Contacts

Public ContactSun Tao

Yantai Mountain Hospital, Yantai City

597131000@qq.com+86 131 2667 0860

Outcome results

None listed

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