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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
Must not have
Patient scheduled to undergo any concomitant shoulder surgical procedures or other surgery which may affect outcomes.
Diagnosis of fibromyalgia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two treatments for shoulder osteoarthritis: injections of processed fat tissue versus traditional injections. The fat is taken from the patient's own body, processed slightly, and then injected into the shoulder. The goal is to see if this new method can better reduce pain and improve joint function compared to traditional methods.
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.
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.
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.
Select...
I have been diagnosed with shoulder arthritis.
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I can walk by myself without help.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am scheduled for shoulder surgery or another surgery that could affect my study results.
Select...
I have been diagnosed with fibromyalgia.
Select...
I have inflammatory arthritis.
Select...
I have a hormone disorder that is not well-managed.
Select...
I manage chronic pain with medication or experience it in multiple body parts.
Select...
I do not have osteomyelitis, HIV, hepatitis C, or poorly controlled diabetes (HgA1C <= 7.0).
Select...
I have had joint replacement or cartilage regeneration surgery.
Select...
I have a blood clotting disorder or am on blood thinners.
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I have had a stem cell injection in my joint before.
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I have a severe shoulder injury involving complete tears in two tendons.
Select...
I am currently receiving treatment to modify my immune system.
Select...
I am younger than 25 or older than 75.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
ASES Shoulder Score
Secondary study objectives
DASH Outcome Measure
Veterans RAND 12 (VR-12) score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for shoulder osteoarthritis include nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroid injections, which primarily reduce inflammation and provide pain relief. Intra-articular injections of Micro Fragmented Adipose Tissue (MFAT) are being studied for their potential to promote tissue repair and reduce inflammation through the action of mesenchymal stem cells (MSCs).
MSCs can differentiate into various cell types and release cytokines that modulate the inflammatory response, potentially improving joint function and slowing disease progression. This is particularly important for shoulder OA patients as it offers a potential treatment that not only alleviates symptoms but also addresses underlying tissue damage and inflammation.
Mesenchymal stem cell therapy in osteoarthritis: advanced tissue repair or intervention with smouldering synovial activation?
Mesenchymal stem cell therapy in osteoarthritis: advanced tissue repair or intervention with smouldering synovial activation?
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,461 Previous Clinical Trials
17,494,826 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
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