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

Launched by CHINESE UNIVERSITY OF HONG KONG · May 2, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with traumatic cartilage injuries, specifically focusing on a type of tissue made from the patient's own bone marrow cells. The goal is to see if this engineered tissue can safely help repair damaged cartilage in the knee, which can be a painful condition and often doesn’t respond to other treatments.

To participate in this study, candidates should be between 18 and 60 years old and have a specific type of cartilage defect in their knee that hasn’t improved with at least four months of standard treatments. Participants will undergo the procedure to receive the engineered tissue and will be monitored for safety and effectiveness. It’s important to note that certain health conditions and previous treatments may disqualify potential participants, so a thorough screening will take place. Overall, this trial aims to find a new way to help those suffering from knee pain due to cartilage damage.

Gender

ALL

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)
• • 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