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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2021-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Stem Cells

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

Group Type ACTIVE_COMPARATOR

Concentrated Bone Marrow Aspirate (BMAC)

Intervention Type BIOLOGICAL

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

Plasma

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

Group Type ACTIVE_COMPARATOR

Platelet-Rich Plasma (PRP)

Intervention Type BIOLOGICAL

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

Interventions

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Concentrated Bone Marrow Aspirate (BMAC)

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

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No