The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT03467919|
Recruitment Status : Active, not recruiting
First Posted : March 16, 2018
Last Update Posted : March 21, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Knee Pain||Biological: Micro Fragmented Adipose Tissue Biological: Corticosteroid injection||Phase 3|
This study will be a randomized controlled trial to compare outcomes between intra-articular injection of Micro Fragmented Adipose Tissue and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the knee. Micro Fragmented Adipose Tissue will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation in the clinic room.
To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of medial and/or lateral weight-bearing compartments (Kellgren-Lawrence Grade 2 or 3). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis|
|Official Title:||The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis|
|Actual Study Start Date :||April 1, 2018|
|Actual Primary Completion Date :||January 26, 2023|
|Estimated Study Completion Date :||January 26, 2025|
Experimental: MFAT(Micro Fragmented Adipose Tissue)
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.
Biological: Micro Fragmented Adipose Tissue
Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
Other Name: MFAT
Active Comparator: Conventional therapy
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
Biological: Corticosteroid injection
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
- Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score [ Time Frame: 24 months ]Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms
- Lysholm score [ Time Frame: 24 months ]Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)
- Veterans RAND 12 (VR-12) score [ Time Frame: 24 months ]Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy
- MRI Cartilage Scan [ Time Frame: 12 months ]Cartilage thickness on MRI using T2-weighted cartilage mapping
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||35 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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 concomitant surgical procedures.
- Coagulopathy or anticoagulant treatment
- Chronic pain involving multiple body parts or opioid medication management
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467919
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Eugene Y Roh, MD||Stanford University|
|Principal Investigator:||Jason Dragoo, MD||Stanford University|
|Principal Investigator:||Seth Sherman, MD||Stanford University|
|Responsible Party:||Eugene Roh, Director, Sports Ultrasound Medicine, Orthobiologics, Stanford University|
|Other Study ID Numbers:||
|First Posted:||March 16, 2018 Key Record Dates|
|Last Update Posted:||March 21, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
adipose derived stem cell
Micro Fragmented Adipose Tissue