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Compares treatment options for Knee Cartilage Defects
Official title Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
ClinicalTrials.gov ID: NCT07339111
What this study is testing
What is CARTISTEM® + Debridement?
CARTISTEM® + Debridement is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for knee cartilage defects.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Failed conservative knee osteoarthritis treatment for at least 3 months prior to consent (weight reduction, physical therapy, injections, pain...
- Kellgren-Lawrence (KL) in the index knee of grade 2 to 3 as determined by independent radiologist review of study X-Ray.
- Clinically relevant femoral cartilage defects classified using modified Outerbridge Grade 3 or 4 in index knee with combined lesion area ≥ 2 cm2 and...
You likely can't join if
- Subject received an IA injection of Hyaluronic Acid (HA), Platelet Rich Plasma (PRP), Bone Marrow Aspirate / Concentrate (BMA / BMAC), long-acting /...
- 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...
- 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.
- Anatomical axis varus or valgus malalignment ≥ 6° in either knee as determined by independent radiologist.
- Joint ligament instability in index knee ≥ Grade 3 or ligament instability that would require surgical intervention as determined by investigator or...
See the full eligibility criteria
Who can join
- 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.
- 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...
- Body Mass Index (BMI) ≤ 35 kg / m2 .
- VAS PAIN index knee score ≥ 40 to ≤ 90 based on 100-point scale at screening.
- VAS PAIN contralateral knee score ≤ 30 based on 100-point scale at screening.
- WOMAC® FUNCTION index knee mean score ≥ 25 to ≤ 90 based on 100-point scale at screening.
- WOMAC® Pain index knee mean score ≥ 40 to ≤ 90 based on 100-point VAS (visual analogue scale) at screening.
- people must be willing to abstain from treatments in the index knee from the time the informed consent is signed until after the last study follow up visit.
- people must be willing to discontinue analgesics except:
- Rescue medication (acetaminophen) allowed for break-through pain throughout the study.
- people must be willing to discontinue use of all pain medications at least 48 hours prior to baseline assessment and each follow up visit.
- Limited postoperative NSAID use is permissible per IND clinical guidance and site manual, provided washout before scheduled how well it works assessments.
- Post operative narcotics.
- people with stage 3 hypertension (systolic ≥ 180 mm Hg and diastolic ≥ 120 mmHg) must have blood pressure (BP) controlled prior to surgical procedure.
- Subject's central lab results are within normal ranges or deemed as not clinically significant by investigator for CARTISTEM® treatment or surgical comparator.
- Female people of childbearing potential must agree to practice adequate methods of birth control to prevent pregnancy during the study.
- people must be able to comply fully with the rehabilitation requirements.
- people must be able to understand and comply with the requirements of the study.
- people must voluntarily provide written informed consent.
What rules you out
- 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...
- 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.
- Anatomical axis varus or valgus malalignment ≥ 6° in either knee as determined by independent radiologist.
- Joint ligament instability in index knee ≥ Grade 3 or ligament instability that would require surgical intervention as determined by investigator or designee.
- Complete meniscal deficiency, meniscal root tears and / or severe meniscal extrusion as determined by independent radiologist.
- 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.
- Surgery of the index knee joint within 6 months of signing the informed consent. Investigator confirms that Subject has recovered from any prior surgical intervention to enable treatment within this study protocol. No...
- Chronic inflammatory articular diseases such as rheumatoid arthritis, gout, pseudogout, gouty arthritis, or fibromyalgia as determined by documented medical history.
- Bone disorders of index knee: osteonecrosis including avascular necrosis (AVN); Osteochondritis dissecans (OCD); Spontaneous Osteonecrosis of the Knee (SONK); Subchondral Insufficiency Fracture (SIF); Subchondral /...
- Joint disorders of the index knee including infection, osteomyelitis, soft tissue tumors, and bone marrow infiltration as determined by independent radiologist review of study MRI or X-ray.
- Diseases or disorders including Paget's disease, ochronosis, acromegaly, haemochromatosis, Wilson's disease, genetic disease (hyperkinesia, etc.), or genetic collagen disorder as determined by documented medical history.
- Vascular or neurological disorders of the lower extremities as determined by documented medical history. Note: Varicose veins are not an exclusion criteria.
- Autoimmune diseases - documented medical history. Addison's Disease, Dermatomyositis, Irritable Bowel Diseases (IBD) or Irritable Bowel Syndrome (IBS) (including Crohn's disease and ulcerative colitis), Multiple...
- Subject has documented systemic diseases such as but not limited to HIV, hepatitis, HTVL, syphilis, and blood coagulopathies (including hemophilia, Von Willebrand disease, thrombocytopenia, disseminated intravascular...
- Subject is taking anticoagulant medication (e.g., warfarin, (Coumadin), apixaban (Eliquis), rivaroxaban (Xarelto), clopidogrel (Plavix) or equivalent) but not excluding 81mg aspirin.
- Uncontrolled diabetes with HbA1c \> 8% as determined by documented medical history.
- Infectious disease requiring parenteral administration of antibiotics.
- Administered immunosuppressants such as Cyclosporin A or azathioprine within 6 months of signing the informed consent.
- Subject has received chemotherapy in the 12 months prior to signing informed consent.
- Subject has received other allogeneic stem cell therapy.
- Prior cartilage repair procedure (such as MACI, ACI, OATS, OCA, Agili-C) in the index knee or the index knee contains a uni-compartmental knee replacement. Revision of a prior microfracture procedure is allowed if...
- Prior invasive knee osteoarthritis treatment including subchondroplasty, cryoneurolysis, genicular nerve ablation, genicular artery embolization, in situ MISHA (medial knee implanted shock absorber), prosthetic implants...
- Known history of hypersensitivity / allergy to hyaluronan.
- Currently pregnant or nursing.
- Psychotic diseases, epilepsy, or any history of such diseases.
- Known substance or alcohol abuse in the prior 3 years.
- Contraindication to MRI imaging or unwillingness to undergo MRI.
- Currently receiving or in litigation related to workman's compensation, personal injury, or disability claims.
- Considered by principal investigator inappropriate for the clinical trial due to any reasons other than those listed above. Baseline PRO Assessment Inclusion Criteria:
- VAS PAIN index knee score ≥ 40 to ≤ 90 based on 100-point scale at baseline PRO assessment.
- WOMAC® FUNCTION index knee mean score ≥ 25 to ≤ 90 based on 100-point scale at baseline PRO assessment. Baseline Surgical Inclusion Criteria: 1\. Treated cartilage defects Outerbridge Grade 3 or 4 in index knee with...
- Meniscal root tears and / or severe meniscal extrusion or non-functional meniscus as determined arthroscopically or by arthrotomy by treating physician.
- 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 arthroscopically or by arthrotomy by treating...
- Bone or joint disorders of the index knee including infection, osteomyelitis, soft tissue tumors, bone marrow infiltration, osteonecrosis (AVN or OCD) as determined arthroscopically or by arthrotomy by treating...
- Identification of prior cartilage repair procedure (such as MACI, ACI, OATS, OCA, Agili-C) or uni-compartmental knee replacement in the index knee as determined arthroscopically or by arthrotomy by treating physician...
- Subject is documented as pregnant based on hCG urine or blood test prior to surgery.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tempe, Arizona, United States
- El Cajon, California, United States
- La Mesa, California, United States
- Santa Monica, California, United States
- Parker, Colorado, United States
- Steamboat Springs, Colorado, United States
- Rochester, Minnesota, United States
- Westwood, New Jersey, United States
- Flushing, New York, United States
- Charlotte, North Carolina, United States
- Morehead City, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- McAllen, Texas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tempe, Arizona, United States; El Cajon, California, United States; La Mesa, California, United States; Santa Monica, California, United States; Parker, Colorado, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.