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

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Florida

Mayo Clinic in Florida; Not yet recruiting

Jacksonville, Florida, United States, 32224

Principal Investigator: Shane Shapiro, MD

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Shane A Shapiro; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Shane A. Shapiro, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03271229 History of Changes
• Other Study ID Numbers: 15-008718
• First Posted: September 5, 2017
• Last Update Posted: May 8, 2019
• Last Verified: May 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

Keywords provided by Shane A. Shapiro, Mayo Clinic:

Platelet rich plasma; bone marrow; stem cell

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases