Shoulder OsteoarthritisPhase 1NCT04826224
CAM Procedure With BMAC for Shoulder OA
A Phase 1 study testing Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure. in people with Shoulder Osteoarthritis, run by Shane A. Shapiro at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Shoulder Osteoarthritis
- What is being tested?
- Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to 21 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study For The Use Of Human Autologous Bone Marrow Aspirate Concentrate (BMAC) Combined With Arthroscopic Surgery For Painful Shoulder Osteoarthritis
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
- Being tested
- Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Reactions
Occurrence of adverse reactions to BMAC when delivered after shoulder CAM procedure
Measured: 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
Measured: 1-3 Weeks Post-Procedure
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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%.
Measured: 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
Measured: 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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start6 Dec 2021
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Why it stopped: Lack of enrollment and funding for study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shane A. Shapiro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shane A. Shapiro, Mayo Clinic
- Investigators
- Bradley Schoch, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826224
- Sponsor's protocol ID
- 20-007731
- Status last verified
- Jan 2026
- First submitted
- 23 Mar 2021
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study For The Use Of Human Autologous Bone Marrow Aspirate Concentrate (BMAC) Combined With Arthroscopic Surgery For Painful Shoulder Osteoarthritis
- ClinicalTrials.gov ID
- NCT04826224
- Acronym / sponsor ID
- 20-007731
- Conditions
- Shoulder Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment and funding for study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Shane A. ShapiroUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Osteoarthritis of the shoulders | Experimental | Biological: Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.Subjects diagnosed with Osteoarthritis of the shoulders will be injected with concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.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. | Biological | Subjects with Osteoarthritis of the shoulders |
Primary outcome
Adverse Reactions
Time frame: 1-3 Weeks Post-Procedure
Occurrence of adverse reactions to BMAC when delivered after shoulder CAM procedure
Morbidity related to bone marrow aspirations from iliac crests
Time frame: 1-3 Weeks Post-Procedure
Occurrence of adverse reactions to bone marrow aspirations from iliac crests
5 secondary outcomes
Change in Visual Analog Scale (VAS)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Lack of enrollment and funding for study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Schoch, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure. in people with Shoulder Osteoarthritis, run by Shane A. Shapiro at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment and funding for study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Reactions (time frame: 1-3 Weeks Post-Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.