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

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03467919

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Knee Pain	Biological: Micro Fragmented Adipose Tissue Biological: Corticosteroid injection	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Micro Fragmented Adipose Tissue (MFAT) on Knee OsteoarthritisMicro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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.

Arm

Intervention/Treatment

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score [24 months]
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms

Secondary Outcome Measures

Lysholm score [24 months]
Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)
Veterans RAND 12 (VR-12) score [24 months]
Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy

Other Outcome Measures

MRI Cartilage Scan [12 months]
Cartilage thickness on MRI using T2-weighted cartilage mapping

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 35 and 75 years-old
Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or

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