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MFAT vs Corticosteroids for Shoulder Osteoarthritis
Phase 1
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 25 and 75 years-old
Diagnosis of pre-existing osteoarthritis of the glenohumeral joint
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is comparing the outcomes of two different treatments for osteoarthritis - one involving injection of Micro Fragmented Adipose Tissue, and the other involving injection of corticosteroid.
Who is the study for?
This trial is for adults aged 25-75 with shoulder osteoarthritis who've tried physical therapy and anti-inflammatory meds without success. They must understand English, be able to follow care instructions, complete surveys, and not have had joint replacement or certain injections recently. Excluded are those with severe arthritis, rotator cuff tears, rheumatologic conditions, uncontrolled endocrine disorders, infections like HIV/HCV or poorly controlled diabetes.Check my eligibility
What is being tested?
The study compares the effects of Micro Fragmented Adipose Tissue (MFAT) injection versus corticosteroid injection in treating shoulder osteoarthritis. It aims to assess which treatment better improves clinical outcomes and function without surgery.See study design
What are the potential side effects?
Possible side effects may include pain at the injection site, swelling, infection risk increase due to the procedure itself. Corticosteroids can also cause joint deterioration with repeated use and temporary increases in blood sugar levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 25 and 75 years old.
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I have been diagnosed with shoulder arthritis.
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I can walk by myself without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ASES Shoulder Score
Secondary outcome measures
DASH Outcome Measure
Veterans RAND 12 (VR-12) score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MFAT (Micro Fragmented Adipose Tissue)Experimental Treatment1 Intervention
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.
Group II: Conventional TherapyActive Control1 Intervention
Intra-articular injection of corticosteroid (Triamcinolone 40mg)
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,398 Previous Clinical Trials
17,342,327 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for shoulder surgery or another surgery that could affect my study results.I have been diagnosed with fibromyalgia.I have inflammatory arthritis.I am between 25 and 75 years old.I have a hormone disorder that is not well-managed.I manage chronic pain with medication or experience it in multiple body parts.I am able to understand and agree to the study's procedures and risks.I do not have osteomyelitis, HIV, hepatitis C, or poorly controlled diabetes (HgA1C <= 7.0).I have had joint replacement or cartilage regeneration surgery.I have a blood clotting disorder or am on blood thinners.I've tried physical therapy and anti-inflammatory meds for over 6 weeks without success.I have had a stem cell injection in my joint before.I can complete surveys online, in person, or by phone.I have a severe shoulder injury involving complete tears in two tendons.I am currently receiving treatment to modify my immune system.I am younger than 25 or older than 75.X-rays show either very little or severe osteoarthritis in the joints.I haven't had cortisone, PRP, or Hyaluronic acid injections in my joints in the last 3 months.I have been diagnosed with shoulder arthritis.I can understand care instructions before and after a procedure.I can walk by myself without help.You have a very high body mass index (BMI) or the doctor can't see your joints clearly using ultrasound.
Research Study Groups:
This trial has the following groups:- Group 1: MFAT (Micro Fragmented Adipose Tissue)
- Group 2: Conventional Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Shoulder Osteoarthritis Patient Testimony for trial: Trial Name: NCT04929951 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still ongoing for this clinical investigation?
"Presently, the clinical trial hosted on clinicialtrials.gov is not accepting patients - this project was first shared on June 7th 2021 and subsequently updated ten days later. However, there are 684 additional medical trials that are actively enrolling participants at present."
Answered by AI
Has the FDA sanctioned the use of Micro Fragmented Adipose Tissue?
"Power analysts have rated the safety of Micro Fragmented Adipose Tissue a 1, as it is merely in its first phase of clinical trials and has minimal evidence backing up its efficacy."
Answered by AI
To whom is this clinical investigation open?
"This medical study has a requirement for 60 participants aged between 25 and 75 who have experienced shoulder pain, even after undergoing conservative therapies such as physical therapy or anti-inflammatory medications. The trial also necessitates that patients are able to understand pre and post procedure care instructions, in addition to completing online/in person surveys for follow up."
Answered by AI
Are youngsters below 35 years of age being admitted to this investigation?
"This medical trial has an age restriction of 25 to 75 years old. Patients younger than the cut off are eligible for 33 other trials, whereas those older than 65 could apply for 645 different studies."
Answered by AI
Who else is applying?
What state do they live in?
California
Texas
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
2
3+
0
What site did they apply to?
Stanford University
Why did patients apply to this trial?
I’m hoping to not having a shoulder replacement in the future. I am trying to avoid a full shoulder replacement. I have server OA in my shoulder.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How many screening visits are needed?
PatientReceived 2+ prior treatments
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