Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engin… (NCT06400862) | Clinical Trial Compass
RecruitingPhase 1
Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engineered Tissues - Engineered Osteochondral Tissue
Hong Kong9 participantsStarted 2024-02-26
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Osteochondritis dissecans
* Multiple or uncontained lesions as detected by MRI or arthroscopy
* Uncorrected ligament deficiency
* Uncorrected varus or valgus malalignment exceeding 5°
* Ongoing Infection or skin diseases at target knee joint
* Significant meniscal loss
Patient Factor---
* Subjects who are not able or not willing to give voluntary, written informed consent to participate in this study
* Skeletal immaturity
* Female subjects who are pregnant or lactating
* Body mass index \> …
What they're measuring
1
Safety Outcomes
Timeframe: From subject enrollment to 24 months after the eOCT implantation.