CompletedPhase 3

The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis

United States40 participantsStarted 2018-04-01

Plain-language 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.

Who can participate

Age range

35 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 35 and 75 years-old * Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3. * 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. Exclusion Criteria: * Age \< 35 or \> 75 years old * Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 ) * Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc) * Previous cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months * Co-morbidity with rheumatologic condition, inflammatory arthritis * Currently undergoing immunomodulatory therapy * Uncontrolled endocrine disorder * BMI \>35 * 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain

Timeframe: Baseline, 3, 6, 12, and 24 months

Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms

Timeframe: Baseline, 3, 6, 12, and 24 months

Trial details

NCT IDNCT03467919

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-29

Results submitted2025-10-25

View on ClinicalTrials.gov More Osteoarthritis, Knee trials

Who can participate

Age range

35 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.