Back to resultsThe Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee, Knee Pain
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Micro Fragmented Adipose Tissue
Corticosteroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, stem cell, knee pain, adipose derived stem cell, injection, MFAT, Micro Fragmented Adipose Tissue
Eligibility Criteria
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 concomitant surgical procedures.
- Coagulopathy or anticoagulant treatment
- Chronic pain involving multiple body parts or opioid medication management
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MFAT(Micro Fragmented Adipose Tissue)
Conventional therapy
Arm Description
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.
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
Outcomes
Primary Outcome Measures
Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms
Secondary Outcome Measures
Lysholm score
Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)
Veterans RAND 12 (VR-12) score
Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03467919
Brief Title
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Official Title
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
January 26, 2025 (Anticipated)
Study Completion Date
March 26, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Knee Pain
Keywords
osteoarthritis, stem cell, knee pain, adipose derived stem cell, injection, MFAT, Micro Fragmented Adipose Tissue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MFAT(Micro Fragmented Adipose Tissue)
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
Intervention Type
Biological
Intervention Name(s)
Micro Fragmented Adipose Tissue
Other Intervention Name(s)
MFAT
Intervention Description
Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
Intervention Type
Biological
Intervention Name(s)
Corticosteroid injection
Intervention Description
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score
Description
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Lysholm score
Description
Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)
Time Frame
24 months
Title
Veterans RAND 12 (VR-12) score
Description
Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
MRI Cartilage Scan
Description
Cartilage thickness on MRI using T2-weighted cartilage mapping
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 concomitant surgical procedures.
Coagulopathy or anticoagulant treatment
Chronic pain involving multiple body parts or opioid medication management
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Y Roh, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Dragoo, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seth Sherman, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
We'll reach out to this number within 24 hrs