Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03271229
Recruitment Status : Withdrawn (Funding)
First Posted : September 5, 2017
Last Update Posted : December 24, 2019
Information provided by (Responsible Party):
Shane A. Shapiro, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Biological: Concentrated Bone Marrow Aspirate (BMAC) Biological: Platelet-Rich Plasma (PRP) Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Stem Cells
Participants will have Concentrated Bone Marrow Aspirate (BMAC) injections into symptomatic knee
Biological: Concentrated Bone Marrow Aspirate (BMAC)
Participants will have a knee injected with BMAC stem cells harvested from the iliac crest

Active Comparator: Plasma
Participants will have Platelet-Rich Plasma (PRP) injections into symptomatic knee
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.

Primary Outcome Measures :
  1. Occurrence of Adverse Events [ Time Frame: approximately 12 months ]
    The number of adverse events

  2. Morbidity [ Time Frame: approximately 12 months ]
    The number of deceased participants

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03271229

Layout table for location information
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Layout table for investigator information
Principal Investigator: Shane A Shapiro Mayo Clinic
Additional Information:
Layout table for additonal information
Responsible Party: Shane A. Shapiro, Principal Investigator, Mayo Clinic Identifier: NCT03271229    
Other Study ID Numbers: 15-008718
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Shane A. Shapiro, Mayo Clinic:
Platelet rich plasma
bone marrow
stem cell
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases