Using bone marrow concentrate to treat shoulder osteoarthritis
A Pilot Study for the Use of Human Autologous Bone Marrow Aspirate Concentrate (BMAC) Combined with Arthroscopic Surgery for Painful Shoulder Osteoarthritis
This study is testing if using bone marrow concentrate after shoulder surgery can safely help people with shoulder osteoarthritis feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT04826224 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and side effects of administering Bone Marrow Aspirate Concentrate (BMAC) following a Comprehensive Arthroscopic Management (CAM) procedure for patients with shoulder osteoarthritis. Participants will receive varying doses of BMAC to determine the optimal amount that can be safely administered. The study aims to evaluate the effectiveness of this treatment approach in alleviating symptoms associated with shoulder osteoarthritis.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with primary shoulder osteoarthritis who have not responded to conservative treatments.
Not a fit: Patients with significant abnormal laboratory results or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from shoulder osteoarthritis.
How similar studies have performed: Other studies have shown promise in using BMAC for joint conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Male and Female subjects. * Subjects must be 50 years of age or older. * Subjects must have OA in a single or bilateral shoulder(s) with an inferior osteophyte measuring \<7 mm. * \> 1 mm joint space width in the study shoulder. * ASES score of 14.1 to 88.5 * 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. 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. If repeat non-clinically relevant, non-life-threatening results do not normalize the patient may be further evaluated by a specialist or primary care provider to determine if lab result should be 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. * Patients taking Coumadin or Plavix
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Bradley Schoch, MD — Mayo Clinic
- Study coordinator: Stephanie McNew, B.S.
- Email: mcnew.stephanie@mayo.edu
- Phone: (904) 953-0580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.