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

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.

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
antimetabalites) 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.