CAM Procedure With BMAC for Shoulder OA (NCT04826224) | Clinical Trial Compass
TerminatedPhase 1
CAM Procedure With BMAC for Shoulder OA
Stopped: Lack of enrollment and funding for study.
United States2 participantsStarted 2021-12-06
Plain-language summary
Researchers want to find out more about the side effects of Bone Marrow Aspirate Concentrate (BMAC) and what doses of BMAC are safe for people.
Who can participate
Age range50 Years
SexALL
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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-th…
What they're measuring
1
Adverse Reactions
Timeframe: 1-3 Weeks Post-Procedure
2
Morbidity related to bone marrow aspirations from iliac crests