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

41688

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.

2018-04-01

2025-01-26

2025-03-26

Active (not recruiting)

Early phase I

40

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

2023-10-06