Bone marrow shot for shoulder pain? tiny study ends early
NCT ID NCT04826224
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This early-stage study aimed to see if a concentrated dose of a person's own bone marrow cells, given during shoulder surgery, is safe for treating painful shoulder arthritis. Only 2 people aged 50 or older took part before the study was stopped. The main goal was to check for side effects, not to prove the treatment works.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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2 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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