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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 35 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03467919
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Stanford University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Eugene Y Roh, MDJason Dragoo, MDSeth Sherman, MD
Principal Investigator Affiliation Stanford UniversityStanford UniversityStanford University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee, Knee Pain
Additional Details

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.

Arms & Interventions

Arms

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.

Active Comparator: Conventional therapy

Intra-articular injection of corticosteroid (Triamcinolone 40mg).

Interventions

Procedure: - Micro Fragmented Adipose Tissue

Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection

Procedure: - Corticosteroid injection

Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University, Stanford, California

Status

Recruiting

Address

Stanford University

Stanford, California, 94305

Site Contact

Eugene Y Roh, MD

[email protected]

650-721-7600