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Recruiting Phase 1 NCT06400862

Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engineered Tissues - Engineered Osteochondral Tissue

Trial Parameters

Condition Traumatic Cartilage Injury
Sponsor Chinese University of Hong Kong
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 9
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2024-02-26
Completion 2026-06-30
Interventions
eOCT implantation

Brief Summary

The objective of the study is to establish the safety profile of the autologous engineered osteochondral tissues (eOCT) in treating traumatic chondral lesions in patients.

Eligibility Criteria

Inclusion Criteria: * Age: Subjects who are in the age range of 18-60 years * Location: Single symptomatic cartilage defect on medial or lateral femoral condyle * Size \& Containment: Contained single focal cartilage lesion of size \~1-4 cm square * Grading: Cartilage damage ICRS/Outerbridge grade III/IV reaching subchondral bone (As diagnosed by MRI) * Conservative treatments failed (for \> 4 months) Exclusion Criteria: Disease Factor--- * Previous cartilage repair surgery (OATS or ACI/MACI) in the index knee * Previous injectional treatments such as HA/PRP/stem cell in the index knee within 3 months before informed consent * Presence of a clinically relevant patellofemoral cartilage lesion in the index knee (patella/trochlea/both) * Inflammatory joint disease (specific or non-specific arthritis) * Metabolic diseases (gout or rheumatism) * Advanced Osteoarthritis (Radiologically apparent degenerative joint disease in the target knee as determined by Kellgren \& Lawrence Grade \>2) * O

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