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. |
ClinicalTrials.gov Identifier: NCT03271229 |
Recruitment Status :
Withdrawn
(Funding)
First Posted : September 5, 2017
Last Update Posted : December 24, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteo Arthritis Knee | Biological: Concentrated Bone Marrow Aspirate (BMAC) Biological: Platelet-Rich Plasma (PRP) | Phase 2 |
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 |

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. |
- 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

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.
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.

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 ClinicalTrials.gov identifier (NCT number): NCT03271229
United States, Florida | |
Mayo Clinic in Florida | |
Jacksonville, Florida, United States, 32224 |
Principal Investigator: | Shane A Shapiro | Mayo Clinic |
Responsible Party: | Shane A. Shapiro, Principal Investigator, Mayo Clinic |
ClinicalTrials.gov 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 |
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 |
Platelet rich plasma bone marrow stem cell |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |