Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee

• ClinicalTrials.gov Identifier: NCT03271229
• Recruitment Status: Not yet recruiting
• First Posted: September 5, 2017
• Last Update Posted: May 8, 2019
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Shane A. Shapiro, Mayo Clinic

Tracking Information

• First Submitted Date: August 31, 2017
• First Posted Date: September 5, 2017
• Last Update Posted Date: May 8, 2019
• Estimated Study Start Date: September 2019
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 31, 2017)

• Occurrence of Adverse Events [ Time Frame: approximately 12 months ]
  The number of adverse events
• Morbidity [ Time Frame: approximately 12 months ]
  The number of deceased participants

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03271229 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee
• Official Title: A Randomized, Single-Blinded, Controlled Trial Comparing Conventional Platelet Rich Plasma (PRP) to Concentrated Bone Marrow Aspirate (BMAC) for Osteoarthritis of the Knee
• 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 different tissue types, while platelet rich plasma contains growth factors. Both techniques have been shown to relieve pain and with this study the Investigators wish to compare the two treatments.
• 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 and the cellular rich portion will be concentrated and subsequently injected into the subjects' symptomatic knee. BMAC patients will also have a venous whole blood drawn from the antecubital vein to simulate a PRP procedure. PRP subjects will have the same venous blood draw from the antecubital vein with subsequent platelet concentration. The resulting PRP will be injected into the symptomatic knee. PRP subjects will also undergo a bone marrow aspiration from the iliac crest to simulate the BMAC procedure. Follow-up at 1 week, 6 weeks, 6 months, and 12 months after injection, with repeat radiographs at 12 months.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Osteo Arthritis Knee

Intervention

• Biological: Concentrated Bone Marrow Aspirate (BMAC)
  Participants will have a knee injected with BMAC stem cells harvested from the iliac crest
• Biological: Platelet-Rich Plasma (PRP)
  Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the antecubital vein.

Study Arms

• Active Comparator: Stem Cells
  Participants will have Concentrated Bone Marrow Aspirate (BMAC) injections into symptomatic knee
  Intervention: Biological: Concentrated Bone Marrow Aspirate (BMAC)
• Active Comparator: Plasma
  Participants will have Platelet-Rich Plasma (PRP) injections into symptomatic knee
  Intervention: Biological: Platelet-Rich Plasma (PRP)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: August 31, 2017): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2021
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03271229
• Other Study ID Numbers: 15-008718
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Shane A. Shapiro, Mayo Clinic
• Study Sponsor: Mayo Clinic
• Collaborators: Not Provided

Investigators

• Principal Investigator: Shane A Shapiro; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: May 2019