RecruitingKnee Cartilage Defects

Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis

Eligible age

18–75 yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

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.

Sponsor: Medipost, Inc.

You may qualify if…

✓ 1. Age ≥ 18 and ≤ 75 years old.
✓ 2. Knee Osteoarthritis diagnosed in the index knee according to the clinical definition of American College of Rheumatology (ACR) guidelines at screening.
✓ 3. Failed conservative knee osteoarthritis treatment for at least 3 months prior to consent (weight reduction, physical therapy, injections, pain medications, etc.).
✓ 4. Kellgren-Lawrence (KL) in the index knee of grade 2 to 3 as determined by independent radiologist review of study X-Ray.
✓ 5. Clinically relevant femoral cartilage defects classified using modified Outerbridge Grade 3 or 4 in index knee with combined lesion area ≥ 2 cm2 and ≤ 9 cm2 and at least a single femoral lesion ≥ 2 cm2 as determined by independent radiologist review of study MRI.
✓ 6. Body Mass Index (BMI) ≤ 35 kg / m2 .
✓ 7. VAS PAIN index knee score ≥ 40 to ≤ 90 based on 100-point scale at screening.
✓ 8. VAS PAIN contralateral knee score ≤ 30 based on 100-point scale at screening.

You may not qualify if…

✕ 1. 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.
✕ 2. 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.
✕ 3. KL index knee grade 0, 1 or 4 as determined by independent radiologist review of study X-Ray.
✕ 4. KL Contralateral knee severity grade 4 as determined by independent radiologist review of study X-Ray.
✕ 5. Anatomical axis varus or valgus malalignment ≥ 6° in either knee as determined by independent radiologist.
✕ 6. Joint ligament instability in index knee ≥ Grade 3 or ligament instability that would require surgical intervention as determined by investigator or designee.
✕ 7. Complete meniscal deficiency, meniscal root tears and / or severe meniscal extrusion as determined by independent radiologist.
✕ 8. Kissing bipolar lesions (tibial or patellar) Outerbridge 4 exceeding 25% of the femoral lesion area in size and/or penetrating through the subchondral bone as determined by independent radiologist.