CAM Procedure + BMAC for Shoulder Osteoarthritis

Overseen By Stephanie McNew, B.S.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Shane A. Shapiro

Must not be taking: Anti-inflammatories, Anti-rheumatics, Opiates, Coumadin

Disqualifiers: Pregnancy, Rheumatic disease, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and side effects of a treatment for shoulder osteoarthritis. It involves a surgical procedure called Comprehensive Arthroscopic Management (CAM) followed by an injection of concentrated bone marrow aspirate, a substance derived from the patient's own bone marrow. The goal is to determine a safe dose and understand its effects. This trial may suit individuals aged 50 and older who have tried treatments like physical therapy or medication for at least six months but continue to struggle with shoulder osteoarthritis. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

Yes, you will need to stop taking anti-inflammatory medications and anti-rheumatic disease medications before joining the trial. Specifically, you must not take anti-inflammatory medications for 14 days before the baseline visit and anti-rheumatic medications for 3 months prior to study entry.

What prior data suggests that the CAM Procedure and BMAC are safe for treating shoulder osteoarthritis?

Research has shown that Bone Marrow Aspirate Concentrate (BMAC) is generally safe for treating joint pain. Studies have found that BMAC can reduce pain and improve joint function. For instance, people with shoulder arthritis who received BMAC reported less pain and better health scores, indicating good tolerance.

Additionally, reviews have found BMAC to be safe, with no major side effects reported. While this treatment is still under investigation, current evidence supports its safety for use in joints. However, as this treatment remains in early trials, further research is necessary to fully understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the CAM Procedure + BMAC for shoulder osteoarthritis because it combines a surgical approach with a regenerative boost. Unlike standard treatments that primarily involve pain management or joint replacement, this innovative approach uses the Comprehensive Arthroscopic Management (CAM) procedure to repair the shoulder joint and follows it up with concentrated bone marrow aspirate (BMAC) injections. BMAC is rich in stem cells, which could promote healing and cartilage regeneration, potentially offering a more sustainable and less invasive solution. This dual approach may not only alleviate symptoms but also address the root cause of osteoarthritis, which is why it's generating a lot of interest.

What evidence suggests that the CAM Procedure and BMAC could be effective for shoulder osteoarthritis?

Research has shown that using concentrated bone marrow aspirate (BMA) in the shoulder joints of people with osteoarthritis can lead to better outcomes. Studies have found that patients treated with BMA report less pain and improved health, as measured by tools like QuickDASH and EQ-5D-5L, which assess disability and quality of life. In this trial, participants will receive a combination of the Comprehensive Arthroscopic Management (CAM) procedure with BMA injections to explore the potential for enhancing these benefits. Although still in the early stages, these findings suggest that BMA could be a promising option for reducing pain and improving function in shoulder osteoarthritis. ^{1 3 5 6 7}

Who Is on the Research Team?

Bradley Schoch, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have tried treatments like physical therapy or medication for 6 months.

I have shoulder arthritis with a small bone growth.

I am either male or female.

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

I have implants or hardware in my shoulder.

Patients participating in a study of an experimental drug or medical device within 30 days of study entry

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Assessment

Participants undergo pre-operative assessments including pain and shoulder function evaluations

1 week

1 visit (in-person)

Treatment

Participants receive arthroscopic surgery followed by injection of Bone Marrow Aspirate Concentrate (BMAC)

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for adverse reactions and morbidity related to the procedure

1-3 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including pain and shoulder function assessments

12 months

Multiple visits at 1 week, 6 weeks, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Arthroscopic Management (CAM) surgical procedure
• Concentrated bone marrow aspirate

Trial Overview 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.

How Is the Trial Designed?

Group I: Subjects with Osteoarthritis of the shoulders Experimental Treatment 1 Intervention

Subjects diagnosed with Osteoarthritis of the shoulders will be injected with concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.

Comprehensive Arthroscopic Management (CAM) surgical procedure is already approved in United States, European Union for the following indications:

Approved in United States as Comprehensive Arthroscopic Management for:

• Severe shoulder osteoarthritis
• Glenohumeral osteoarthritis

Approved in European Union as Comprehensive Arthroscopic Management for:

• Severe shoulder osteoarthritis
• Glenohumeral osteoarthritis

Who Is Running the Clinical Trial?

Shane A. Shapiro

Lead Sponsor

Trials

2

Recruited

10+

Published Research Related to This Trial

Intra-articular injections of low-volume bone marrow aspirate harvested using the Marrow Cellution™ device significantly reduced pain in knee osteoarthritis patients, with VAS scores improving from 7.29 to 3.76 over six months (p < 0.0001).

A substantial 71% of patients showed improvements in VAS scores that surpassed the minimal clinically important difference, indicating that this treatment is not only effective but also leads to meaningful pain relief and improved function in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term Efficacy of Using a Novel Low-Volume Bone Marrow Aspiration Technique to Treat Knee Osteoarthritis: A Retrospective Cohort Study. Kuebler, D., Schnee, A., Moore, L., et al.[2022]

Bone marrow aspirate concentrate (BMAC) injections significantly improve pain and patient-reported outcomes in knee osteoarthritis, with 94.4% of outcomes showing improvement over a mean follow-up of 12.9 months across 299 knees.

Despite its effectiveness, BMAC did not show clinical superiority over other treatments like platelet-rich plasma or microfragmented adipose tissue, and its high cost may limit its use compared to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate for the Treatment of Knee Osteoarthritis: A Systematic Review. Keeling, LE., Belk, JW., Kraeutler, MJ., et al.[2022]

Bone marrow aspirate concentrate (BMAC) shows potential for treating knee cartilage defects, with clinical studies indicating improved outcomes compared to traditional methods like microfracture, although the overall quality of these studies is low.

Animal studies have produced inconsistent results regarding the efficacy of BMAC, and the cells in BMAC do not meet the criteria for mesenchymal stem cells, suggesting that further research is needed to fully understand its mechanism and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Bone Marrow Aspirate Concentrate for the Treatment of Focal Chondral Lesions of the Knee: A Systematic Review and Critical Analysis of Animal and Clinical Studies. Cavinatto, L., Hinckel, BB., Tomlinson, RE., et al.[2020]

In a study involving 25 shoulders from 22 patients with glenohumeral joint osteoarthritis, a single injection of nonconcentrated bone marrow aspirate (BMA) led to significant improvements in pain and function as measured by the QuickDASH and EQ-5D-5L scales over 12 months, compared to no significant changes in the cortisone group.

While the BMA group showed better outcomes in specific measures, there was no significant difference in the overall WOOS scores between the BMA and cortisone groups, indicating that while BMA may be more effective in certain aspects, further research with larger sample sizes is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injection of Bone Marrow Aspirate for Glenohumeral Joint Osteoarthritis: A Pilot Randomized Control Trial. Dwyer, T., Hoit, G., Lee, A., et al.[2022]

In a study of 124 patients undergoing arthroscopic acetabular labral repair, those who received bone marrow aspirate concentrate (BMAC) showed significantly greater functional improvements at 12 and 24 months compared to those who did not receive BMAC, particularly in patients with moderate cartilage damage.

While BMAC did not show a significant difference in overall outcomes for all patients, it provided notable benefits for those with moderate cartilage injury, suggesting its potential as an effective adjuvant therapy in this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Outcomes of Arthroscopic Acetabular Labral Repair with and without Bone Marrow Aspirate Concentrate. Martin, SD., Kucharik, MP., Abraham, PF., et al.[2023]

The Harvest SmartPrep 3 system demonstrated greater consistency in concentrating white blood cells compared to the Arthrex Angel system, indicating it may be more reliable for certain therapeutic applications.

Different BMAC preparation systems yield varying compositions of cell types, with Harvest recovering the highest percentages of colony-forming unit-fibroblasts and CD34+ cells, while Biomet excelled in platelet recovery, suggesting that each system has unique advantages for specific treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Consistency and Composition of Commercially Available Bone Marrow Aspirate Concentrate Systems. Dragoo, JL., Guzman, RA.[2022]

The effectiveness of bone marrow aspirate concentrate (BMAC) for treating chondral defects in the knee is still uncertain, indicating that its clinical use should be approached with caution.

Accurate terminology regarding the types of cells used in stem cell therapies is essential for evaluating their safety and efficacy, highlighting the need for further research before BMAC can be routinely applied in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Considering Clinical Application of Bone Marrow Aspirate Concentrate for Restoration of Cartilage Defects in the Knee? Is It a Kind of Stem Cell Therapy? Ha, CW., Park, YB.[2020]

The comprehensive arthroscopic management (CAM) procedure significantly improved shoulder function and reduced pain in 25 patients with glenohumeral osteoarthritis after a mean follow-up of 42.4 months, with all postoperative assessments showing improvement.

The CAM procedure, performed without axillary nerve release or subacromial decompression, had a low failure rate of 12% leading to shoulder arthroplasty, indicating it is a safe and effective option for active patients with advanced GHOA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive arthroscopic management without axillary nerve release or subacromial decompression achieves satisfactory and durable results in young patients with glenohumeral osteoarthritis. Lopez-Fernandez, V., Luengo-Alonso, G., Valencia, M., et al.[2023]

Citations

1. mayo.edu mayo.edu/research/clinical-trials/tests-procedures/bone-marrow-aspirate-concentrate-injection

Bone Marrow Aspirate Concentrate Injection Clinical Trials The purpose of this study is to evaluate the safety and feasibility of concentrated bone marrow aspirate administration after Comprehensive Arthroscopic ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT04826224

CAM Procedure with BMAC for Shoulder OA Study Purpose. 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8527259/

Injection of Bone Marrow Aspirate for Glenohumeral Joint ... The results of this study demonstrate that patients with GHJ OA treated with BMA have superior changes in the QuickDASH and EQ-5D-5L pain and health scores.

4. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/shoulder-arthritis

Shoulder Arthritis Clinical Trials The purpose of this study is to evaluate the safety and feasibility of concentrated bone marrow aspirate administration after Comprehensive Arthroscopic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03580148

BMA vs Cortisone for Glenohumeral Osteoarthritis (BMAC) This randomized trial seeks to investigate the difference if any between cortisone injection versus bone marrow aspirate injection in the glenohumeral joint ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20509066

Clinical Trials The purpose of this study is to evaluate the safety and feasibility of concentrated bone marrow aspirate administration after Comprehensive Arthroscopic ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11208346/

Safety and Efficacy of Bone-Marrow Aspirate Concentrate ... The results from this review demonstrated that administration of BMAC is safe and potentially efficacious in terms of reducing pain, improving function and ...