Microfragmented Adipose Tissue Compared to Corticosteroid Injection for the Treatment of Knee Osteoarthritis

NCT05660772 | Completed Phase 3 DMC FDA Device

• 1 other identifier: LIPO-001
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 18

Brief Summary

The goal of this clinical trial is to examine the effect of a single autologous, intra-articular injection of MFat versus corticosteroid injection for the treatment of pain and function associated with K/L grade 2/3 knee Osteoarthritis. Participants will receive an injection of MFat or a corticosteroid.

Conditions

Knee Osteoarthritis; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (2)

• Change in Western Ontario and McMaster Universities Osteoarthritis Index Pain (WOMAC-A) VA3.1 Score

  The change from baseline to Month 12 for the Western Ontario and McMaster Universities Osteoarthritis Index pain (WOMAC-A) subscale score (superiority); Scale = 0-100, where 100 is extreme pain

  12-month visit

• WOMAC-C Subscale Score

  The change from baseline to Month 12 for the Western Ontario and McMaster Universities Osteoarthritis Index function (WOMAC-C) subscale score (non-inferiority), scale 0-100, where 100 is extreme difficulty performing a function.

  12-month visit

Secondary Outcomes (3)

• Change in WOMAC-A Pain Sub Score

  12-month visit

• Change in WOMAC-C Function Sub Score

  12-month visit

• Change in Total WOMAC scores

  12-month visit

Study Arms (2)

Corticosteroid Injection

ACTIVE COMPARATOR

The cases assigned to this group will be injected intra-articularly in the knee with a corticosteroid. It will be administered once at the baseline visit of the study.

Drug: Corticosteroid

Microfragmented Adipose Tissue (Mfat)

EXPERIMENTAL

Injection of Microfragmented Adipose Tissue derived using Lipogems® Kit The cases assigned to this group will be injected intra-articularly with Lipogems®. The patients will undergo lipoaspiration of their own adipose tissue for Mfat then this Mfat will be injected intra-articularly in the knee. It will be administered once at the baseline visit of the study.

Device: Microfragmented Adipose Tissue

Interventions

Microfragmented Adipose Tissue DEVICE

Microfragmented Adipose Tissue derived using Lipogems® Kit

Also known as: Mfat

Microfragmented Adipose Tissue (Mfat)

Corticosteroid DRUG

intra-articular knee injection of corticosteroid

Also known as: steroid

Corticosteroid Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, participants must meet all of the following criteria:
• Age ≥ 18 years old at the date of screening
• Have both clinical and radiographic findings consistent with osteoarthritis of the knee:
• Participant has clinical findings including (but not limited to) tenderness to palpation, swelling/effusion, stiffness, chronic limited range of motion.
• Participant has a diagnosis of knee OA defined as Grade 2 to 3 by (K/L) weight bearing X-ray and physician review within the past 3 months.
• The index knee must present with symptomatic knee pain using WOMAC-A Visual Analog Scale (VAS) of 40mm or greater despite conservative therapies for 3 months prior to enrollment:
• Willing to give written Informed Consent to voluntarily participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) Authorization prior to study participation
• Ability to return for multiple follow-up visits
• Ability read and understand English language
• Females of child-bearing potential must have a negative urine pregnancy test performed within 7 days of study enrollment or be postmenopausal (for at least 2 years) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from participating in this study. Study eligibility of participants reporting isolated use of prohibited medications during the restricted periods defined by this protocol, will be evaluated on a case-by-case basis by the medical monitor.
• Diagnosis of knee OA defined as K/L grade 1 or 4.
• BMI greater than 35 kg/m2.
• Diagnosis of rheumatoid arthritis, psoriatic arthritis, or any other disorder which attributes to the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer.
• Presence of any clinically observed active infection including in the index knee joint, infection at the site of adipose tissue harvest, and/or any active systemic or local infection.
• Undergone injection in target knee within 6 months prior to screening visit, including but not limited to corticosteroids, hyaluronic acid (HA), bone marrow concentrate (BMAC) platelet rich plasma (PRP), human cellular exosomes, amniotic fluid or any human birth tissue.
• Undergone surgical procedures of either knee within 6 months prior to the screening visit.
• Bilateral knee pathology can only be treated in one knee for the study. The contralateral knee must have a WOMAC-A Visual Analog Scale (VAS) pain score of no more than 20mm for the past 3 months prior to enrollmentat the time of screening (48-hr recall).
• Index knee greater than 10 degrees varus/valgus deformities (anatomic tibiofemoral angle).
• Knee pain associated with osteochondritis dissecans, ligament damage or displaced meniscus tear.
• Current or historical autoimmune disease that requires immunosuppressive medication.
• Any disorder affecting musculoskeletal pain and/or function, including symptomatic OA of the back, hips, or ankle that would interfere with the evaluation of the treated knee.
• Planned or expected surgery within the next 12 months.
• Allergy to lidocaine, epinephrine, or valium.
• Diagnosis of HIV or viral hepatitis.

Sponsors & Collaborators

• Lipogems International spa: lead
• Alira Health: collaborator

Study Sites (18)

CORE Orthopaedic Center

Encinitas, California, 92024, United States

Location

Stanford University

Redwood City, California, 94063, United States

Location

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

Location

Pinnacle Trials, Inc

Atlanta, Georgia, 30327, United States

Location

Emory University

Brookhaven, Georgia, 30329, United States

Location

University of Iowa Sports Medicine

Iowa City, Iowa, 52242, United States

Location

Regenerative Orthopedics and Sports Medicine (ROSM)

North Bethesda, Maryland, 20852, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Northwell Health

New York, New York, 10065, United States

Location

Columbia University

Tarrytown, New York, 10591, United States

Location

Atrium Health

Charlotte, North Carolina, 28211, United States

Location

Cincinnati Sports Medicine and Orthopaedic Center

Cincinnati, Ohio, 45236, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

The Orthopedic Center

Tulsa, Oklahoma, 74104, United States

Location

All American Ortho

Houston, Texas, 77058, United States

Location

Texas Center for Cell Therapy and Research, LLC

San Antonio, Texas, 78240, United States

Location

San Antonio Orthopedics

San Antonio, Texas, 78258, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones; Steroids

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor, Investigator, Participant are blinded. Unblinded operator will perform procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: December 30, 2022
• Primary Completion: April 9, 2025
• Study Completion: April 9, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

US (18)