CAM Procedure With BMAC for Shoulder OA

Study Overview
=================
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.

Official Title
-----------------
A Pilot Study For The Use Of Human Autologous Bone Marrow Aspirate Concentrate (BMAC) Combined With Arthroscopic Surgery For Painful Shoulder Osteoarthritis

Conditions
-----------------
Shoulder Osteoarthritis

Intervention / Treatment
-----------------
* Biological: Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with Osteoarthritis of the shoulders<br>Subjects diagnosed with Osteoarthritis of the shoulders will be injected with concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure. | Biological: Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Reactions | 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 | 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) | 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) | 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 | 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 | 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. | Assessment of structural changes of the shoulder on conventional radiographs including measurement of inferior humeral osteophyte and joint space width | 12 Months |