Status:
WITHDRAWN
Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee
Lead Sponsor:
Mayo Clinic
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Previous clinical trials have demonstrated the human body's own healing and regenerative cells can relieve the pain of arthritis. Bone marrow contains stem cells which can change into cells of various...
Detailed Description
Participants will be randomized into two groups. Concentrated Bone Marrow Aspirate (BMAC) or Platelet-Rich Plasma (PRP). BMAC subjects will have bone marrow aspirated from the subjects iliac crests an...
Eligibility Criteria
Inclusion
- Subjects must have bilateral OA and pain in one knee.
- Osteoarthritis may be primary or secondary. Knees must have Kellgren-Lawrence Grades 1-3.
- Subjects must have previously tried 6 weeks of one of the following conservative treatments: Activity modification, weight loss, physical therapy, anti-inflammatory, or injection therapy.
- Patients must be able to provide written informed consent after the nature of the study is fully explained.
Exclusion
- Patients with abnormal hematology, serum chemistry, or screening laboratory results.
- Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit.
- Patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry.
- Patients receiving injections to the treated knee within 3 months prior to study entry.
- Patients who are pregnant or currently breast-feeding.
- Patients with systemic, rheumatic, or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
- Patients with ongoing known infectious disease.
- Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, or cancer.
- Patients participating in a study of an experimental drug or medical device within 30 days of study entry.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03271229
Start Date
September 1 2019
End Date
January 1 2021
Last Update
December 24 2019
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224