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

12 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment CAM Procedure + BMAC for Shoulder Osteoarthritis?

Research shows that bone marrow aspirate concentrate (BMAC) has been used to treat osteoarthritis in other joints, like the hip and knee, with some success in improving symptoms and slowing cartilage damage. However, results can vary due to different preparation methods, and more research is needed to confirm its effectiveness specifically for shoulder osteoarthritis. ^{1 2 3 4 5}

Is the CAM Procedure + BMAC treatment generally safe for humans?

The safety of Bone Marrow Aspirate Concentrate (BMAC) has been studied in various conditions, but more research is needed to fully understand its safety and effectiveness. While it is used in orthopedic treatments, the results and safety can vary depending on the preparation methods and specific conditions being treated. ^{1 3 4 6 7}

How is the CAM Procedure + BMAC treatment different from other treatments for shoulder osteoarthritis?

The CAM Procedure + BMAC treatment is unique because it combines a joint-preserving surgical technique (CAM) with bone marrow aspirate concentrate (BMAC), which may help slow cartilage damage and improve outcomes, especially in young or active patients with shoulder osteoarthritis. ^{1 4 5 6 8}

What is the purpose of this trial?

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.

Research Team

Bradley Schoch, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate for the Treatment of Knee Osteoarthritis: A Systematic Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Consistency and Composition of Commercially Available Bone Marrow Aspirate Concentrate Systems. [2022]

4. United States 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Functional Outcomes of Arthroscopic Acetabular Labral Repair with and without Bone Marrow Aspirate Concentrate. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Injection of Bone Marrow Aspirate for Glenohumeral Joint Osteoarthritis: A Pilot Randomized Control Trial. [2022]

7. United States 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? [2020]

8. Germany 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. [2023]