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

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

Tracking Information
First Submitted Date  ICMJE August 31, 2017
First Posted Date  ICMJE September 5, 2017
Last Update Posted Date May 8, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT03271229 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Osteo Arthritis Knee
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2017)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03271229
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Shane A. Shapiro, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shane A Shapiro Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP