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

NCT03271229 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 15-008718
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

Platelet rich plasma; bone marrow; stem cell

Outcome Measures

Primary Outcomes (2)

• Occurrence of Adverse Events

  The number of adverse events

  approximately 12 months

• Morbidity

  The number of deceased participants

  approximately 12 months

Study Arms (2)

Stem Cells

ACTIVE COMPARATOR

Participants will have Concentrated Bone Marrow Aspirate (BMAC) injections into symptomatic knee

Biological: Concentrated Bone Marrow Aspirate (BMAC)

Plasma

ACTIVE COMPARATOR

Participants will have Platelet-Rich Plasma (PRP) injections into symptomatic knee

Biological: Platelet-Rich Plasma (PRP)

Interventions

Concentrated Bone Marrow Aspirate (BMAC) BIOLOGICAL

Participants will have a knee injected with BMAC stem cells harvested from the iliac crest

Stem Cells

Platelet-Rich Plasma (PRP) BIOLOGICAL

Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the antecubital vein.

Plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Shane A Shapiro

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 5, 2017
• Study Start: September 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: December 24, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)