A Study to Evaluate Comprehensive Arthroscopic Management (CAM) Procedure with Bone Marrow Aspirate Concentrate (BMAC) for Shoulder Osteoarthritis (OA)

Overview

About this study

The purpose of this study is to evaluate the safety and feasibility of concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure, and to determine pain relief, disease progression and range of motion in patients with osteoarthritis of the shoulder.

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male and Female subjects.
  • Subjects must be 50 years of age or older.
  • Subjects must have OA in a single shoulder with an inferior osteophyte measuring 4-7 mm. 
  • > 1 mm joint space width.
  • Osteoarthritis must be primary.  Subjects must have previously tried 6 months of one of the following conservative treatments: activity modification, physical therapy, and anti-inflammatory or injection therapy.
  • Patients can provide written informed consent after the nature of the study is fully explained.

Exclusion Criteria:

  • Patients with clinically significant abnormal hematology, serum chemistry, or urinalysis screening laboratory results. If the laboratory reports a single, non-clinically relevant, non-life-threatening result for any of these studies and is the only excluding factor it may be repeated 1 week later if the patient wishes.  Normalization of that laboratory study will then be considered non-exclusionary
  • Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit.
  • Walch Type B2/C glenoid. 
  • 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 shoulder within 3 months prior to study entry,
  • Patients who are pregnant or currently breast-feeding children.
  • Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 3 months following completion of the drug treatment cycle.  Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years.  A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results.  If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
  • Patients with systemic, rheumatic or inflammatory disease of the shoulder or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the shoulder associated with juxta-articular Paget’s disease, ochronosis, hemophilic arthropathy, infectious arthritis, villonodular synovitis, and synovial chondromatosis.
  • Patients with ongoing infectious disease, including HIV and hepatitis.
  • Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes.
  • Patients participating in a study of an experimental drug or medical device within 30 days of study entry.
  • Patients with hardware or implants in the affected shoulder.
  • Patients with previous open shoulder surgery or an arthroscopic procedure requiring structural repair with anchors and/or sutures.
  • Presence of large glenoid cysts
  • Opiate use within three months.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Bradley Schoch, M.D.

Open for enrollment

Contact information:

Elizabeth Starck

(904) 953-7971

Starck.Elizabeth@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20509066

Mayo Clinic Footer