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CAM Procedure + BMAC for Shoulder Osteoarthritis
Phase 1
Recruiting
Led By Bradley Schoch, MD
Research Sponsored by Shane A. Shapiro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
Awards & highlights
Study Summary
This trial will help researchers understand more about the side effects of BMAC and what doses are safe for people to use.
Who is the study for?
This trial is for men and women over 50 with primary shoulder osteoarthritis who've tried treatments like physical therapy or anti-inflammatory drugs for at least 6 months. They must have a specific level of joint space in the affected shoulder and an ASES score within a certain range. Excluded are those with other significant health issues, recent use of certain medications, or previous major shoulder surgeries.Check my eligibility
What is being tested?
The study tests the safety and side effects of different doses of Bone Marrow Aspirate Concentrate (BMAC) administered after Comprehensive Arthroscopic Management (CAM) surgery in patients with shoulder osteoarthritis to see if it can help manage their condition.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include pain at the injection site, infection risk from the procedure, allergic reactions to BMAC components, bleeding complications due to bone marrow aspiration, or possible worsening of arthritis symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
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I have shoulder arthritis with a small bone growth.
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The space in my shoulder joint is more than 1 mm wide.
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My osteoarthritis is not caused by another condition.
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I have tried treatments like physical therapy or medication for 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Reactions
Morbidity related to bone marrow aspirations from iliac crests
Secondary outcome measures
Change in American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Change in Subjective Shoulder Value
Change in Visual Analog Scale (VAS)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Subjects with Osteoarthritis of the shouldersExperimental Treatment1 Intervention
Subjects diagnosed with Osteoarthritis of the shoulders will be injected with concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.
Find a Location
Who is running the clinical trial?
Shane A. ShapiroLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Bradley Schoch, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
20,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have implants or hardware in my shoulder.I have tried treatments like physical therapy or medication for 6 months.I have had shoulder surgery involving repair with anchors or sutures.I am not pregnant or breastfeeding and agree to use birth control during the study.I have shoulder arthritis with a small bone growth.I am either male or female.I am either male or female.I have a shoulder condition related to systemic or inflammatory disease.I haven't taken any anti-inflammatory medications, including herbal ones, in the last 14 days.My shoulder condition is classified as Walch Type B2/C.I have a serious heart, kidney, liver, hormone-related condition, cancer, or diabetes.I am currently taking Coumadin or Plavix.I have taken medication for rheumatic disease in the last 3 months.I am 50 years old or older.I have not had injections in my shoulder in the last 3 months.I do not have any ongoing infectious diseases like HIV or hepatitis.The space in my shoulder joint is more than 1 mm wide.My osteoarthritis is not caused by another condition.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects with Osteoarthritis of the shoulders
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Shoulder Osteoarthritis Patient Testimony for trial: Trial Name: NCT04826224 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you discuss the potential hazards of administering concentrated bone marrow aspirate following Comprehensive Arthroscopic Management (CAM) surgery?
"We assessed the safety of Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure to be a 1 due to its phase one status, as this indicates limited evidence for both efficacy and security."
Answered by AI
How many individuals are currently engaged in this clinical trial?
"Correct. Clinicaltrials.gov reveals that this research is presently looking for participants, having posted the trial on April 6th 2021 and last updated it May 26th 2022. The study needs 12 people to enrol at one medical facility."
Answered by AI
What outcomes is this clinical trial attempting to attain?
"This clinical trial's primary goal, which will be monitored over a period of 1-3 weeks post-treatment, is to assess the morbidity related to bone marrow aspirations from iliac crests. Secondary objectives include evaluating changes in American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV) - scored on a 100 point scale where higher indicates better outcome - as well as range of motion measured in degrees."
Answered by AI
Are there any openings for enrollment in this experiment?
"According to the clinicaltrials.gov listing, participant recruitment for this medical research is ongoing and actively seeking patients. This study was initially published on April 6th 2021 with its most recent edit occuring May 26th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Mayo Clinic in Florida
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I would like to find a way to help prevent or prolong a shoulder replacement.
PatientReceived no prior treatments
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