Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    I What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Jacksonville, Florida: 12-004459
  • NCT ID:

    NCT01931007
  • Sponsor Protocol Number:

    12-004459

About this study

The overall goal of this study is to develop regenerative cell therapy for use in patients with osteoarthritis (OA). The primary objective of this proposal is to conduct a pilot study that assesses the safety and feasibility of using concentrated bone marrow aspirate containing MSC to treat patients with painful knee OA.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Shane Shapiro, M.D.

Closed for enrollment

Shari Kazmerchak

(904)953-2496

Kazmerchak.Shari@mayo.edu