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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial compares the outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus intra-articular injection of corticosteroid.
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.Check my eligibility
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.See study design
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.
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
Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score
Secondary outcome measures
Lysholm score
Veterans RAND 12 (VR-12) score
Other outcome measures
MRI Cartilage Scan
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).
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,396 Previous Clinical Trials
17,341,515 Total Patients Enrolled
16 Trials studying Osteoarthritis
5,015 Patients Enrolled for Osteoarthritis
Eugene Y Roh, MDPrincipal InvestigatorStanford University
Jason Dragoo, MDPrincipal InvestigatorStanford University
3 Previous Clinical Trials
175 Total Patients Enrolled
1 Trials studying Osteoarthritis
134 Patients Enrolled for Osteoarthritis
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:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
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