Osteoarthritis ShoulderPhase 1NCT04929951
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
A Phase 1 study testing Micro Fragmented Adipose Tissue and Corticosteroid injection in people with Osteoarthritis Shoulder and Shoulder Pain, run by Stanford University at 1 site in United States.
Trial summary
This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Osteoarthritis Shoulder, Shoulder Pain
- What is being tested?
- Micro Fragmented Adipose Tissue and Corticosteroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2022to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 25 and 75 years-old
- Diagnosis of pre-existing osteoarthritis of the glenohumeral joint
- Working understanding of the English language and able to fully understand the procedure
- Capable of providing informed consent
- Able to complete online, in-person or phone surveys for the purposes of follow-up
- Capable of understanding pre- and post-procedure care instructions
- Ambulatory at baseline
- Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications if not contraindicated, with or without concomitant bracing and/or injections.
Who cannot join
- Age < 25 or > 75 years old
- Radiographs demonstrating either no, little osteoarthritis, severe(bone on bone) osteoarthritis
- Prior total or partial joint replacement surgery or surgery involving cartilage regeneration
- Previous cortisone, PRP or Hyaluronic acid intra-articular injection within the last 3 months
- Co-morbidity with the rheumatologic condition, inflammatory arthritis
- Currently undergoing immunomodulatory therapy
Show all 16Show fewer
- Uncontrolled endocrine disorder
- BMI >40 or joint space not visible by ultrasound
- Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV), infection, and poorly controlled diabetes (HgA1C >7.0)
- Pregnancy or planned pregnancy
- previous stem cell injection into treatment joint
- Patient scheduled to undergo any concomitant shoulder surgical procedures or other surgery which may affect outcomes.
- Coagulopathy or anticoagulant treatment
- Chronic pain involving multiple body parts or opioid medication management
- Diagnosis of fibromyalgia
- Concomitant massive(2 tendons with retraction), complete rotator cuff tendon tear
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Jessica Nguyen, BS, (650)723-0003, jessn16@stanford.edu
Elizabeth(Telsie) Jameiro, MD, (650)723-0003, ejameiro@stanford.edu
About this study
This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.
Read the detailed description
This study will be a randomized controlled trial to compare outcomes between intra-articular injection of Micro Fragmented Adipose Tissue and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the shoulder. Micro Fragmented Adipose Tissue will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation in the clinic room.
To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of the shoulder (glenohumeral joint). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
- Conditions
- Osteoarthritis Shoulder, Shoulder Pain
- Being tested
- Micro Fragmented Adipose Tissue, Corticosteroid injection
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro Fragmented Adipose TissueBiological
Also called MFAT
Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
Corticosteroid injectionBiological
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
| Study group | Role | What they receive |
|---|---|---|
| MFAT (Micro Fragmented Adipose Tissue) | Experimental | Intra-articular shoulder injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation. This harvested tissue will then be injected into the patient's shoulder. Receives: Biological: Micro Fragmented Adipose Tissue |
| Conventional Therapy | Active comparator | Intra-articular injection of corticosteroid (Triamcinolone 40mg) Receives: Biological: Corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASES Shoulder Score
Patient reported outcome measure that reports shoulder pain and shoulder functionality
Measured: 24 Months
Secondary outcomes (2)
DASH Outcome Measure
Patient reported questionnaire that measures physical function and symptoms
Measured: 24 Months
Veterans RAND 12 (VR-12) score
Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start28 Jul 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ShoulderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugene Roh, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929951
- Sponsor's protocol ID
- 59461
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2021
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
- ClinicalTrials.gov ID
- NCT04929951
- Acronym / sponsor ID
- 59461
- Conditions
- Osteoarthritis Shoulder, Shoulder Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jun 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.
This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.
Detailed description
This study will be a randomized controlled trial to compare outcomes between intra-articular injection of Micro Fragmented Adipose Tissue and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the shoulder. Micro Fragmented Adipose Tissue will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation in the clinic room.
To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of the shoulder (glenohumeral joint). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
| Arm | Type | Receives |
|---|---|---|
| MFAT (Micro Fragmented Adipose Tissue) | Experimental | Biological: Micro Fragmented Adipose TissueIntra-articular shoulder injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation. This harvested tissue will then be injected into the patient's shoulder. |
| Conventional Therapy | Active comparator | Biological: Corticosteroid injectionIntra-articular injection of corticosteroid (Triamcinolone 40mg) |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 25 and 75 years-old
- Diagnosis of pre-existing osteoarthritis of the glenohumeral joint
- Working understanding of the English language and able to fully understand the procedure
- Capable of providing informed consent
- Able to complete online, in-person or phone surveys for the purposes of follow-up
Key exclusion criteria (16 listed)
- Age < 25 or > 75 years old
- Radiographs demonstrating either no, little osteoarthritis, severe(bone on bone) osteoarthritis
- Prior total or partial joint replacement surgery or surgery involving cartilage regeneration
- Previous cortisone, PRP or Hyaluronic acid intra-articular injection within the last 3 months
- Co-morbidity with the rheumatologic condition, inflammatory arthritis
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 |
|---|---|---|
| Micro Fragmented Adipose TissueAlso: MFATHarvesting of Micro Fragmented Adipose Tissue with intra-articular injection | Biological | MFAT (Micro Fragmented Adipose Tissue) |
| Corticosteroid injectionSham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid. | Biological | Conventional Therapy |
Primary outcome
ASES Shoulder Score
Time frame: 24 Months
Patient reported outcome measure that reports shoulder pain and shoulder functionality
2 secondary outcomes
DASH Outcome Measure
Time frame: 24 Months
Veterans RAND 12 (VR-12) score
Time frame: 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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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.
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 Micro Fragmented Adipose Tissue and Corticosteroid injection in people with Osteoarthritis Shoulder and Shoulder Pain, run by Stanford University 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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 17 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASES Shoulder Score (time frame: 24 Months). 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 17 Aug 2026.