Clinical trial NCT03467919: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Knee Pain
Keywords: osteoarthritis
stem cell
knee pain
adipose derived stem cell
injection
MFAT
Micro Fragmented Adipose Tissue
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score
timeFrame: 24 months
Secondary outcomes:
measure: Lysholm score
timeFrame: 24 months
measure: Veterans RAND 12 (VR-12) score
timeFrame: 24 months
Other outcomes:
measure: MRI Cartilage Scan
timeFrame: 12 months
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Eugene Y Roh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Jason Dragoo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Seth Sherman, MD
role: PRINCIPAL_INVESTIGATOR
References: