Trial of REcycled CartiLage Auto/Allo IMplantation for the Treatment and Repair of Focal Knee Cartilage Defects (RECLAIM)

Overview

About this study

The purpose of this study is to test the safety of this novel cell, combination- based regenerative therapy for use in patients with symptomatic focal cartilage defects of the knee.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female ages 18-50 years.
  • Persons of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 2 years following treatment.
  • Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed by qualified personnel using kit.  Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
  • Chronic (> 3 months), unilaterally symptomatic, ICRS Grade III or IV cartilage lesions ranging in size from 2 to 8 cm^2.
  • Radiographic knee OA of Kellgren-Lawrence Grade 1 or less, consisting of normal knee radiographs (Grade 0) or doubtful narrowing of the joint space and possible osteophytic lipping (Grade 1).
  • Previous 6 week or longer trial of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory medications or injection therapy (e.g., cortisone).  An adequate trial will consist of pursuance and reasonable execution (i.e., > 80% medication or therapy compliance) of medically reasonable course of non-operative modalities with minimal to no improvements in symptoms.
  • If applicable, at least 3 months will have passed since the last target knee intraarticular injection prior to undergoing the RECLAIM procedure and at least 6 months will have passed between any prior arthroscopic or open knee procedures.
  • Able to routinely walk without assistance (e.g., cane, walker).
  • Clinically stable target knee.  Patients undergoing primary anterior crucial ligament (ACL) reconstruction will be eligible for inclusion if their target knee is otherwise stable and well-aligned.
  • No additional surgery planned in the target knee for at least 12 months following the RECLAIM procedure.
  • Completed general physical and well-being evaluation with primary care provider within 12 months of enrollment.
  • Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments.
  • Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure.

Exclusion Criteria

  • Pregnant or nursing, or planning on becoming pregnant during the study period.
  • Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study treatment or analysis of the results.
  • Significant knee malalignment that is not corrected at the time of RECLAIM surgery.
  • Injections of any kind into the target knee within 3 months prior to study enrollment.
  • Greater than 50% preoperative loss in native meniscus volume (i.e., meniscectomy, degenerative loss) in the surgical knee compartment.  Patients undergoing repair of meniscus tears without > 50% meniscus volume loss will remain eligible for inclusion.
  • History of intra-articular infection in the target knee.
  • History of superficial infection in the target knee within 6 months of study enrollment, or evidence of current superficial infection affecting the target knee.
  • Clinically significant abnormal hematology (complete blood count with differential), blood chemistry, or urinalysis screening laboratory results. Absolute cutoffs for exclusion include hemoglobin < 11 g / dL, platelets < 110,000 platelets / mL, and an INR greater than 1.3.
  • Body mass index (BMI) > 35 kg/m^2.
  • Taking anticoagulant medications (e.g. warfarin, heparin or clopidogrel) which may pose a clinically-significant contraindication to the surgical RECLAIM procedure.
  • Taking herbal therapies or supplements within 4 weeks of enrollment or unwilling to avoid use of herbal therapies or supplements until study completion (includes, but not limited to chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin).
  • Taking non-steroidal anti-inflammatory medications (e.g. COX-2 inhibitors) without a stable dosing regimen for at least 4 weeks before baseline evaluation, or anticipating not remaining on a stable dose until study completion.
  • On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids.
  • Current tobacco product use, including nicotine patch or other nicotine products.
  • Clinically significant rheumatological or inflammatory disease or chondrocalcinosis/calcium pyrophosphate disease (CPPD), hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget’s disease of the femur or tibia, ochronosis, hemophilic arthropathy, systemic sclerosis, system lupus erythematosus, and Ehlers-Danlos Syndrome, infectious arthritis, Charcot’s knee joint, villonodular synovitis, and synovial chondromatosis.
  • Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis.
  • Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension), neurologic (e.g., stroke, TIA) renal, hepatic, orthopedic (e.g. surgery on other weight bearing joints that will interfere with study, osteoporosis, acute lower body fractures), or endocrine disease (e.g., diabetes).
  • Any clinically significant comorbidity affecting the patient's inability to undergo surgery.
  • Vascular or neurological disorder affecting either lower limb which poses clinical significance to the safety of the operative RECLAIM procedure.
  • History of cancer/malignancy with the exception of adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target knee.
  • History of clinically significant blood dyscrasia including, but not limited to, anemia, thrombocytopenia, and monoclonal gammopathy.
  • Participation in a study of an experimental drug or medical device within 3 months of study enrollment.
  • Known allergy to local anesthetics or other components of the study drug. This includes known allergy or contraindications to products of bovine origin (including aprotinin) or hypersensitivity to antibiotics, if the latter are used in the manufacturing process.
  • Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures.
  • History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or use of medical marijuana within 30 days of study entry.
  • Any illness or condition which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interefere with the interpretation of the study results.
  • History of coagulopathy, including bleeding diathesis and deep venous thrombosis/pulmonary embolism.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aaron Krych, M.D.

Open for enrollment

Contact information:

Ciara Terry

(507) 538-3562

Terry.Ciara@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20438797

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