- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04826224
CAM Procedure With BMAC for Shoulder OA
April 9, 2024 updated by: Shane A. Shapiro
A Pilot Study For The Use Of Human Autologous Bone Marrow Aspirate Concentrate (BMAC) Combined With Arthroscopic Surgery For Painful Shoulder Osteoarthritis
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer Arthurs, APRN
- Phone Number: (904) 953-2000
- Email: Arthurs.Jennifer@mayo.edu
Study Contact Backup
- Name: Stephanie McNew, B.S.
- Phone Number: (904) 953-0580
- Email: mcnew.stephanie@mayo.edu
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Recruiting
- Mayo Clinic in Florida
-
Contact:
- Jennifer Arthurs
- Email: Arthurs.Jennifer@mayo.edu
-
Contact:
- Stephanie McNew, BS, CRC
- Phone Number: 904-953-0580
- Email: McNew.Stephanie@mayo.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subjects with Osteoarthritis of the shoulders
Subjects diagnosed with Osteoarthritis of the shoulders will be injected with concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.
|
Bone marrow aspirate concentrate contains a median nucleated cell count of 121,700/uL, and platelets of 384,000/uL.
This leads to a cellular dose of approximately 400 million cells.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Reactions
Time Frame: 1-3 Weeks Post-Procedure
|
Occurrence of adverse reactions to BMAC when delivered after shoulder CAM procedure
|
1-3 Weeks Post-Procedure
|
Morbidity related to bone marrow aspirations from iliac crests
Time Frame: 1-3 Weeks Post-Procedure
|
Occurrence of adverse reactions to bone marrow aspirations from iliac crests
|
1-3 Weeks Post-Procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Visual Analog Scale (VAS)
Time Frame: Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
|
Measured using the VAS questionnaire: a validated, subjective measure for pain.
Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10).
|
Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
|
Change in American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time Frame: Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery.
|
Measured using the self-reported ASES questionnaire that combines pain and activities of daily living (ADL) scores for a total score out of 100, where a higher score indicates a better outcome.
|
Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery.
|
Change in Subjective Shoulder Value
Time Frame: Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
|
Subjective Shoulder Value (SSV) is a single-item self-completed measure in which patients are asked to grade their shoulder as a percentage of an entirely normal shoulder, which would score 100%.
|
Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
|
Change in range of motion
Time Frame: Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
|
Measured in degrees
|
Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
|
To collect and explore pre and post injection measures of cartilage status in the affected shoulder.
Time Frame: 12 Months
|
Assessment of structural changes of the shoulder on conventional radiographs including measurement of inferior humeral osteophyte and joint space width
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bradley Schoch, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2021
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
March 23, 2021
First Submitted That Met QC Criteria
March 29, 2021
First Posted (Actual)
April 1, 2021
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-007731
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shoulder Osteoarthritis
-
Indiana Hand to Shoulder CenterCTM BiomedicalActive, not recruitingShoulder Osteoarthritis | Osteoarthritis Shoulder | Glenohumeral OsteoarthritisUnited States
-
Smith & Nephew, Inc.Recruiting
-
Lovisenberg Diakonale HospitalHaukeland University Hospital; Sykehuset Telemark; University Hospital, AkershusRecruitingShoulder Osteoarthritis | Arthroplasty, Replacement, ShoulderNorway
-
University Hospital, BrestUnknownShoulder Osteoarthritis | Arthropathy ShoulderFrance
-
FX Shoulder SolutionsRecruitingOsteoarthritis Shoulder | Rotator Cuff Syndrome of Shoulder and Allied Disorders | Fracture, ShoulderUnited States
-
Northwestern UniversityWithdrawnShoulder Osteoarthritis | Arthropathy ShoulderUnited States
-
FX Shoulder SolutionsRecruitingOsteoarthritis Shoulder | Rotator Cuff Syndrome of Shoulder and Allied Disorders | Fracture, ShoulderUnited States
-
Zealand University HospitalHvidovre University HospitalActive, not recruitingShoulder Pain | Shoulder Osteoarthritis | Shoulder ArthritisDenmark
-
Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
-
MaterialiseEnrolling by invitationOsteoarthritis of the Shoulder | Arthroplasty, Replacement, Shoulder | Glenoid CavityBelgium, Netherlands