To establish the efficacy and safety of CARTISTEM®, a combination product composed of allogeneic human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) formulated with a cross-linked sodium hyaluronate (HA) hydrogel, CARTISTEM® compared to the surgical comparator of debridement in Subjects with knee cartilage lesions and osteoarthritis.
This trial is intended to provide evidence of the superiority of CARTISTEM® to reduce knee pain and improve knee function compared to debridement for Subjects with knee cartilage lesions and osteoarthritis at 2-years post-treatment.
Additionally, this trial is intended to intended to explore whether CARTISTEM® may have disease-modifying effects on osteoarthritis progression through the use of semi-quantitative MRI assessment.
Age ≥ 18 and ≤ 75 years old.
Knee Osteoarthritis diagnosed in the index knee according to the clinical definition of American College of Rheumatology (ACR) guidelines at screening.
Failed conservative knee osteoarthritis treatment for at least 3 months prior to consent (weight reduction, physical therapy, injections, pain medications, etc.).
Kellgren-Lawrence (KL) in the index knee of grade 2 to 3 as determined by independent radiologist review of study X-Ray.
Subject received an IA injection of Hyaluronic Acid (HA), Platelet Rich Plasma (PRP), Bone Marrow Aspirate / Concentrate (BMA / BMAC), long-acting / conventional steroid, or investigational drug in either knee within 3 months of signing informed consent. Note: injections of the contralateral knee are allowed during the trial.
Bone marrow lesion (BML) grade 3 on femur, tibia, or patella except at femoral lesion area (BML grade 3 allowed) in index knee as determined by independent radiologist review of study MRI.
KL index knee grade 0, 1 or 4 as determined by independent radiologist review of study X-Ray.
KL Contralateral knee severity grade 4 as determined by independent radiologist review of study X-Ray.
Parallel
CARTISTEM® + Debridement
Biological/VaccineCARTISTEM® + Debridement CARTISTEM® consists of approximately 7.5 x 106 hUCB-MSCs (human umbilical cord blood-derived mesenchymal stem/stromal cells) suspended in 1.5 ml medium in one vial, and 60 mg sodium hyaluronate provided as a lyophilized powder in a separate vial. A viscous and malleable gel matrix is formed by mixing hUCB-MSCs (main component) and 60mg of sodium hyaluronate at a 4% concentration (excipient).
Debridement
Procedure/SurgeryDebridement of unstable cartilage in and around cartilage lesion(s) in the knee.
Visual Analog Scale (VAS) Pain Score
Change from Baseline Visual Analog Scale (VAS) Pain score (0-100 point scale, 0 being no pain at one end and 100 being the worst imaginable pain at the other) in index knee comparing CARTISTEM® to surgical control at 24-months post-treatment.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) Function score
Change from Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) Function score (0-100 point scale, 0 being the best functioning and 100 being the worst functioning) in index knee comparing CARTISTEM® to surgical control at 24-months post-treatment.
Modified Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score
Change in modified MOCART score in Index knee comparing CARTISTEM® to surgical control at 24-months post-treatment.
Change in MRI Osteoarthritis Knee Score (MOAKS) cartilage morphology
Change in MOAKS cartilage morphology with delta sum score - extent of cartilage damage score in Index knee comparing CARTISTEM® to surgical control at 24-months post-treatment.
Change in Western Ontario and McMaster Universities OA Index (WOMAC®) Total score (0-100 point scale, 0 being no osteoarthritis symptoms and 100 being the worst symptoms) in index knee comparing CARTISTEM® to surgical control at 24-months post-treatment.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) Stiffness score (0-100 point scale, 0 being the no stiffness, 100 being the most) in index knee comparing CARTISTEM® to surgical control at 24-months post-treatment.
Change in EuroQoL 5 Dimensions, 5 Levels (5D-5L, with 0 being the worst and 100 being the best) comparing CARTISTEM® to surgical control at 24-months post-treatment.
Change in MOAKS intercondylar synovitis comparing CARTISTEM® to surgical control at 24-months post-treatment.
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