Clinical trial NCT04826224: CAM Procedure with BMAC for Shoulder OA
Official title: A Pilot Study for the Use of Human Autologous Bone Marrow Aspirate Concentrate (BMAC) Combined with Arthroscopic Surgery for Painful Shoulder Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Shoulder Osteoarthritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Adverse Reactions
timeFrame: 1-3 Weeks Post-Procedure
measure: Morbidity related to bone marrow aspirations from iliac crests
timeFrame: 1-3 Weeks Post-Procedure
Secondary outcomes:
measure: Change in Visual Analog Scale (VAS)
timeFrame: Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
measure: Change in American Shoulder and Elbow Surgeons Shoulder Score (ASES)
timeFrame: Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery.
measure: Change in Subjective Shoulder Value
timeFrame: Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
measure: Change in range of motion
timeFrame: Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
measure: To collect and explore pre and post injection measures of cartilage status in the affected shoulder.
timeFrame: 12 Months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Bradley Schoch, MD
role: PRINCIPAL_INVESTIGATOR
References: