CAM Procedure With BMAC for Shoulder OA

NCT04826224 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 20-007731
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in Visual Analog Scale (VAS)

  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)

  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

  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

  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.

  12 Months

Study Arms (1)

Subjects with Osteoarthritis of the shoulders

EXPERIMENTAL

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.

Interventions

Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure. BIOLOGICAL

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.

Subjects with Osteoarthritis of the shoulders

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shane A. Shapiro: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Bradley Schoch, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Regulatory Sponsor

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 1, 2021
• Study Start: December 6, 2021
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)