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

NCT06121882 | Active Not Recruiting Phase 3 DMC FDA Device

• 1 other identifier: LIPO-002
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 16

Brief Summary

The goal of this clinical trial is to examine the effect of a single autologous, intra-articular injection of MFat versus saline 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 saline.

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

• Change in WOMAC-C (function) 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 Pain Sub Score

  12-month visit

• Change in Total WOMAC scores

  12-month visit

Study Arms (2)

Micro Fragmented 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 derived using the Lipogems® System

Saline Injection

ACTIVE COMPARATOR

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

Drug: Saline Injection

Interventions

Microfragmented Adipose Tissue derived using the Lipogems® System DEVICE

Intra-articular knee injection of Microfragmented Adipose Tissue (MFat) derived using the Lipogems® System.

Also known as: MFat

Micro Fragmented Adipose Tissue (MFat)

Saline Injection DRUG

Intra-articular knee injection of saline

Saline 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:
• CONFIDENTIAL Page 12 of 52 Version 2.0, 10JUL2023
• 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 at 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 (16)

Arizona Bone, Joint and Sports Medicine Center LLC

Phoenix, Arizona, 85012, United States

Location

CORE Orthopaedic Medical Center

Encinitas, California, 92024, United States

Location

Horizon Clinical Research

La Mesa, California, 91942, United States

Location

Andrews Research & Ed Foundation

Gulf Breeze, Florida, 32561, United States

Location

Hospital for Special Surgery Florida

West Palm Beach, Florida, 33401, United States

Location

Pinnacle Trials, Inc

Atlanta, Georgia, 30327, United States

Location

Fascia Institute and Treatment (FIT) Center

Metairie, Louisiana, 70001, United States

Location

Ochsner Sports Medicine Institute

New Orleans, Louisiana, 70121, United States

Location

Regenerative Orthopedics & Sports Medicine

Rockville, Maryland, 20852, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

The Orthopedic Center - NextStage Clinical Research - Tulsa

Tulsa, Oklahoma, 74104, United States

Location

LeHigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Vanderbilt Orthopaedics

Nashville, Tennessee, 37209, United States

Location

All American Ortho - NextStage Clinical Research

Houston, Texas, 77058, United States

Location

Texas Center for Cell Therapy and Research, LLC

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor) 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: November 2, 2023
• First Posted: November 8, 2023
• Study Start: March 15, 2024
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

US (16)