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

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 (Asdiagnosed 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 3months 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 thetarget 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 consentto 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 beforeinformed consent or intramuscular or oral steroids within the last 30 days beforeinformed 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., takingimmunosuppressants; 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 thatwould 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 lowerextremities
• Poor general health condition as judged by investigator
• Unable to do follow up