Using engineered tissues to treat knee cartilage injuries
Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engineered Tissues - Engineered Osteochondral Tissue
This study is testing a new way to treat knee cartilage injuries using specially made tissues from the patient's own cells to see if it helps them heal safely.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 2 sites (Jordon and 1 other locations) |
| Trial ID | NCT06400862 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety of autologous engineered osteochondral tissues (eOCT) in patients suffering from traumatic chondral lesions. It involves a single-arm, first-in-human approach where patients will undergo bone marrow aspiration to harvest mesenchymal stem/stromal cells for the manufacturing of eOCT. The cartilage lesions will be repaired through arthroscopic surgery approximately 13 weeks after the pre-treatment visit, followed by a rehabilitation program. Patients will be monitored for up to 24 months post-implantation to assess safety and effectiveness through various clinical evaluations and imaging techniques.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a single symptomatic cartilage defect on the medial or lateral femoral condyle that has not responded to conservative treatments.
Not a fit: Patients with previous cartilage repair surgeries, inflammatory joint diseases, or advanced osteoarthritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for patients with traumatic knee cartilage injuries, potentially improving healing and function.
How similar studies have performed: While this approach is novel, similar studies using engineered tissues for cartilage repair have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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) * 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 \> 30 kg/m2 * Malignancy * Steroid therapy by systemic or intra-articular route within the last 60 days before informed consent or intramuscular or oral steroids within the last 30 days before informed consent * Contraindications to MR imaging * Drug addiction (including narcotic, anesthetic or alcohol addiction) * Patients who are at higher risk for post-surgical bleeding (e.g., bleeding disorder; taking anticoagulants except low dose aspirin * Patients who are at higher risk for post-surgical infection (e.g., taking immunosuppressants; have a severe infection or a history of serious infection) * Known allergy to porcine/bovine collagen * Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee * Patients with human immunodeficiency virus, hepatitis, or syphilis * Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities * Poor general health condition as judged by investigator * Unable to do follow up
Where this trial is running
Jordon and 1 other locations
- Queen Elizabeth Hospital — Jordon, Hong Kong (Recruiting)
- Prince of Wales Hospital — Shatin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Barbara Pui CHAN, PhD — Chinese University of Hong Kong
- Study coordinator: Barbara Pui CHAN, PhD
- Email: bpchan@cuhk.edu.hk
- Phone: +852-3943-0509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.