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MFAT for Knee Osteoarthritis
Phase 3
Waitlist Available
Led By Eugene Y Roh, MD
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 35 and 75 years-old
Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3
Must not have
Uncontrolled endocrine disorder
Age < 35 or > 75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial compares the effects of injecting processed fat tissue versus traditional steroid injections in patients with mild to moderate knee osteoarthritis. The fat is taken from the patient's body, slightly processed, and then injected into the knee to help heal and reduce pain and swelling.
Who is the study for?
This trial is for adults aged 35-75 with moderate knee osteoarthritis who've tried physical therapy and anti-inflammatories without success. They must understand English, be able to complete surveys, follow instructions, and walk on their own. Excluded are those outside the age range, severe or minimal arthritis, recent joint injections, high BMI (>35), pregnancy plans, certain medical conditions like uncontrolled diabetes or coagulopathy.
What is being tested?
The study compares two treatments for knee pain due to osteoarthritis: an injection of Micro Fragmented Adipose Tissue (MFAT) versus a standard corticosteroid injection. The goal is to see which treatment better improves clinical outcomes and function in patients.
What are the potential side effects?
Potential side effects may include pain at the injection site, swelling, infection risk increase from injections generally. Corticosteroids can also cause skin discoloration or thinning around the injection area and temporary flare-ups of joint pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 35 and 75 years old.
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I have moderate osteoarthritis according to the Kellgren-Lawrence scale.
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I am able to understand and agree to the study's procedures and risks.
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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 have a hormone disorder that is not well-managed.
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I am younger than 35 or older than 75 years old.
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I have a blood clotting disorder or am on blood thinners.
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I manage chronic pain with medication or experience it in multiple body parts.
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I have osteomyelitis, HIV, hepatitis C, or poorly controlled diabetes (HgA1C >7.0).
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I am scheduled for surgery soon.
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My X-rays show I have little to no osteoarthritis.
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I have had joint replacement or cartilage regeneration surgery.
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I have a rheumatologic condition or inflammatory arthritis.
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I am currently receiving treatment to modify my immune system.
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I have had a stem cell injection in my joint before.
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My BMI is over 35.
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
Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score
Secondary study objectives
Lysholm score
Veterans RAND 12 (VR-12) score
Other study objectives
MRI Cartilage Scan
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 knee 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 knee.
Group II: Conventional therapyActive Control1 Intervention
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Micro Fragmented Adipose Tissue
2018
Completed Phase 3
~40
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 osteoarthritis (OA) include intra-articular injections of Micro Fragmented Adipose Tissue (MFAT), which promote tissue repair and reduce inflammation through the action of mesenchymal stem cells (MSCs). MSCs can differentiate into various cell types and release paracrine factors that modulate the local environment, reducing inflammation and promoting cartilage repair.
Platelet-rich plasma (PRP) is another treatment that provides high concentrations of growth factors to enhance tissue regeneration and reduce inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids are also used to manage pain and inflammation, although they do not promote tissue repair.
Understanding these mechanisms is crucial for OA patients as it helps them make informed decisions about treatments that not only alleviate symptoms but also potentially slow disease progression.
The paracrine effect of adipose-derived stem cells inhibits osteoarthritis progression.Mesenchymal stem cell therapy in osteoarthritis: advanced tissue repair or intervention with smouldering synovial activation?
The paracrine effect of adipose-derived stem cells inhibits osteoarthritis progression.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
2,484 Previous Clinical Trials
17,516,081 Total Patients Enrolled
17 Trials studying Osteoarthritis
5,107 Patients Enrolled for Osteoarthritis
Eugene Y Roh, MDPrincipal InvestigatorStanford University
Seth Sherman, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate osteoarthritis according to the Kellgren-Lawrence scale.I have a hormone disorder that is not well-managed.I am younger than 35 or older than 75 years old.I am between 35 and 75 years old.I understand how to care for myself before and after the procedure.I have a blood clotting disorder or am on blood thinners.I am able to understand and agree to the study's procedures and risks.I have osteomyelitis, HIV, hepatitis C, or poorly controlled diabetes (HgA1C >7.0).I am scheduled for surgery soon.My X-rays show I have little to no osteoarthritis.I have had joint replacement or cartilage regeneration surgery.I have had a cortisone or hyaluronic acid joint injection in the past 3 months.I have a rheumatologic condition or inflammatory arthritis.I manage chronic pain with medication or experience it in multiple body parts.I've tried physical therapy and anti-inflammatory meds for over 6 weeks without success.I can walk by myself without help.I am currently receiving treatment to modify my immune system.I have had a stem cell injection in my joint before.My BMI is over 35.I've tried physical therapy and anti-inflammatory meds for over 6 weeks without success.
Research Study Groups:
This trial has the following groups:- Group 1: MFAT(Micro Fragmented Adipose Tissue)
- Group 2: Conventional therapy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.