Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis

Patients with symptomatic mild to moderate bilateral knee osteoarthritis will be candidates
for this pilot study. Baseline data includes radiographs, MRI imaging, clinical data on knee
pain and analysis of synovial fluid inflammatory markers. Bone marrow will be aspirated from
the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one
knee will be injected with the bone marrow concentrate. The contralateral knee will be
injected with only sterile saline for placebo. Follow-up analysis of synovial fluid will be
at one week and 6 months after injection; clinical data will be obtained at 3, 6 and 12
months and MRI imaging will be performed at 6 months after injection, with repeat
radiographs at 12 months

Inclusion Criteria:

1. Male and Female subjects are both eligible

2. Subjects must be 18 years of age or older

3. Subjects must have bilateral OA and pain in both knees.

4. Osteoarthritis may be primary or secondary. Knees must have Kellgren-Lawrence Grades
1-3.

5. 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

6. Patients can provide written informed consent after the nature of the study is fully
explained

Exclusion Criteria:

1. Patients with abnormal hematology, serum chemistry, or urinalysis screening
laboratory results.

2. Patients taking anti-inflammatory medications (prescription or over-the-counter),
including herbal therapies, within 14 days of baseline visit.

3. Patients taking anti-rheumatic disease medication (including methotrexate or other
antimetabolites) within the 3 months prior to study entry.

4. Patients receiving injections to the treated knee within 2 months prior to study
entry.

5. Patients who are pregnant or currently breast-feeding children.

6. 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.

7. Patients with ongoing infectious disease, including HIV and hepatitis

8. Patients with clinically significant cardiovascular, renal, hepatic, endocrine
disease, cancer, or diabetes

9. Patients participating in a study of an experimental drug or medical device within 30
days of study entry.