Back to resultsConventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee
Primary Purpose
Osteo Arthritis Knee
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Concentrated Bone Marrow Aspirate (BMAC)
Platelet-Rich Plasma (PRP)
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Platelet rich plasma, bone marrow, stem cell
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.
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Stem Cells
Plasma
Arm Description
Participants will have Concentrated Bone Marrow Aspirate (BMAC) injections into symptomatic knee
Participants will have Platelet-Rich Plasma (PRP) injections into symptomatic knee
Outcomes
Primary Outcome Measures
Occurrence of Adverse Events
The number of adverse events
Morbidity
The number of deceased participants
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03271229
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Funding
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Platelet rich plasma, bone marrow, stem cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stem Cells
Arm Type
Active Comparator
Arm Description
Participants will have Concentrated Bone Marrow Aspirate (BMAC) injections into symptomatic knee
Arm Title
Plasma
Arm Type
Active Comparator
Arm Description
Participants will have Platelet-Rich Plasma (PRP) injections into symptomatic knee
Intervention Type
Biological
Intervention Name(s)
Concentrated Bone Marrow Aspirate (BMAC)
Intervention Description
Participants will have a knee injected with BMAC stem cells harvested from the iliac crest
Intervention Type
Biological
Intervention Name(s)
Platelet-Rich Plasma (PRP)
Intervention Description
Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the antecubital vein.
Primary Outcome Measure Information:
Title
Occurrence of Adverse Events
Description
The number of adverse events
Time Frame
approximately 12 months
Title
Morbidity
Description
The number of deceased participants
Time Frame
approximately 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shane A Shapiro
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee
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