Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis (ARISE2)

May 17, 2024 updated by: Lipogems International spa

A Randomized, Multi-center, Double Blind, Parallel Study to Examine the Effect of Lipogems Processed Microfragmented Adipose Tissue in Comparison to Saline for the Treatment of Knee Osteoarthritis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will investigate The Lipogems System in a clinical study to examine the effect of adipose tissue processed using The Lipogems System in comparison to saline for the treatment of knee osteoarthritis. This study will be randomized and double-blinded. The subjects will be randomized at a 2:1 ratio (investigational to control) and will enroll 173 patients at up to 20 sites in the United States.

Study Type

Interventional

Enrollment (Estimated)

173

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Recruiting
        • Arizona Bone, Joint and Sports Medicine Center LLC
        • Contact:
        • Principal Investigator:
          • Tariq Awan, MD
      • Scottsdale, Arizona, United States, 85259
        • Not yet recruiting
        • Mayo Clinic - Arizona
        • Contact:
        • Principal Investigator:
          • Gregory Umphrey, MD
        • Sub-Investigator:
          • Bryan Ganter, MD
    • California
      • Encinitas, California, United States, 92024
        • Recruiting
        • CORE Orthopaedic Medical Center
        • Principal Investigator:
          • Nathan Hammel, MD
        • Contact:
      • La Mesa, California, United States, 91942
        • Recruiting
        • Horizon Clinical Research
        • Principal Investigator:
          • Scott Hacker, MD
        • Contact:
      • Sonora, California, United States, 95370
        • Recruiting
        • Restore Orthopedics and Sports Medicine
        • Contact:
        • Principal Investigator:
          • Ariana DeMers, MD
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Not yet recruiting
        • Baptist Health South Florida, Inc.
        • Principal Investigator:
          • Anthony Miniaci, MD
        • Contact:
      • Gulf Breeze, Florida, United States, 32561
        • Recruiting
        • Andrews Research & Ed Foundation
        • Contact:
        • Principal Investigator:
          • Joshua Hackel
      • West Palm Beach, Florida, United States, 33401
        • Not yet recruiting
        • Hospital for Special Surgery Florida
        • Contact:
        • Principal Investigator:
          • Martin Roche
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Recruiting
        • Pinnacle Trials, Inc
        • Contact:
        • Principal Investigator:
          • Francisco Chevres
        • Sub-Investigator:
          • Rajiv Pandya
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Not yet recruiting
        • Ochsner Sports Medicine Institute
        • Principal Investigator:
          • Deryk Jones, MD
        • Contact:
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Recruiting
        • Regenerative Orthopedics & Sports Medicine
        • Principal Investigator:
          • John Ferrell, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - Rochester
        • Contact:
        • Principal Investigator:
          • Jacob Sellon, MD
        • Sub-Investigator:
          • Brennan Boettcher, DO
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • The Orthopedic Center - NextStage Clinical Research - Tulsa
        • Principal Investigator:
          • Yogesh Mittal, MD
        • Contact:
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Recruiting
        • Lehigh Center for Clinical Research
        • Contact:
        • Principal Investigator:
          • Robert Palumbo
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Not yet recruiting
        • Vanderbilt Orthopaedics
        • Contact:
        • Principal Investigator:
          • Lauren Porras, MD
    • Texas
      • Addison, Texas, United States, 75001
        • Recruiting
        • Ten20Medical Research
        • Principal Investigator:
          • John East
        • Contact:
      • Houston, Texas, United States, 77058
        • Recruiting
        • All American Ortho - NextStage Clinical Research
        • Principal Investigator:
          • Matthew Higgs, MD
        • Contact:
        • Sub-Investigator:
          • Cristin Mathew, MD
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Center for Cell Therapy and Research, LLC
        • Contact:
        • Principal Investigator:
          • Jaime Garza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • In order to be eligible to participate in this study, participants must meet all of the following criteria:

    1. Age ≥ 18 years old at the date of screening

    2. Have both clinical and radiographic findings consistent with osteoarthritis of the knee:

      1. Participant has clinical findings including (but not limited to) tenderness to palpation, swelling/effusion, stiffness, chronic limited range of motion.
      2. 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.

    3. 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

      a. Failure of conservative therapies include the following: Participants must have failed a minimum of at least 3 months, including (1) physical therapy, and (2) oral OTC pain medications such as an NSAID (Aleve® or Advil®) or Acetaminophen (Tylenol®), or a prescription NSAID, for a period of 90 days at the Maximum Tolerable Dose according to the respective manufacturer's instructions on dose and duration, or their physician's over-riding guidance. Patients who are unable to tolerate this dosing regimen for 90 days, or those in whom NSAIDS or Acetaminophen are contraindicated, shall be deemed to have satisfied this inclusion criteria.

    4. 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
    5. Ability to return for multiple follow-up visits
    6. Ability read and understand English language
    7. 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)

Exclusion Criteria:

  • 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.

    1. Diagnosis of knee OA defined as K/L grade 1 or 4.
    2. BMI greater than 35 kg/m2.
    3. 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.
    4. 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.
    5. 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.
    6. Undergone surgical procedures of either knee within 6 months prior to the screening visit.
    7. 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).
    8. Index knee greater than 10 degrees varus/valgus deformities (anatomic tibiofemoral angle).
    9. Knee pain associated with osteochondritis dissecans, ligament damage or displaced meniscus tear.
    10. Current or historical autoimmune disease that requires immunosuppressive medication.
    11. 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.
    12. Planned or expected surgery within the next 12 months.
    13. Allergy to lidocaine, epinephrine, or valium.
    14. Diagnosis of HIV or viral hepatitis.
    15. Use of oral systemic corticosteroids within the last 90 days and for the duration of the study.
    16. History of any chemotherapy or radiation therapy of the targeted/treatment leg or adipose harvest site.
    17. Active worker's compensation case.
    18. Diagnosis of coagulation disorders (e.g., Von Willebrand's disease) and/or currently on anti-coagulant therapy.
    19. Occurrence of knee trauma to the index knee within six months prior to screening.
    20. Unwilling to stop usage of over-the-counter pain medication (e.g., Acetaminophen or NSAID), "Rescue Analgesics", for 7 days prior to any follow-up visit, with the exception of one "baby aspirin" per day for cardiovascular therapy or prophylaxis.
    21. Unwilling to stop taking prescription pain or prescription anti-inflammatory medication for the duration of the study, with the exception of Tramadol during the immediate post-procedure period noted below.
    22. Unwilling to abstain from NSAIDS for 7 days pre-injection and 2 weeks post-injection. Tramadol is allowed during the 72 hours immediately post-injection, with diary documentation of usage.
    23. Currently taking prescription pain medication for a condition other than the index knee.
    24. Currently in prison.
    25. Untreated symptomatic injury of the index knee (e.g., acute traumatic injury, anterior cruciate ligament injury, clinically symptomatic meniscus injury characterized by mechanical issue such as locking or catching).
    26. Impossibility to harvest enough adipose tissue.

    27. Any medical issue that the clinician feels would be a contraindication to the study treatment including, but not limited to:

      1. Uncontrolled diabetes defined as HbA1c >7%,
      2. History of uncontrolled hypertension defined by average systolic BP >140 mmHg or diastolic BP > 90 mmHg on ≥ 3 blood pressure medications,
      3. History of cardiovascular disease,
      4. History of cerebrovascular disease,
      5. Uncontrolled asthma, defined as symptomatic (i.e., shortness of breath and/or wheezing) despite therapy,
      6. History of solid organ or hematologic transplantation,
      7. Diagnosis of non-basal cell malignancy within preceding 5 years,
      8. Change in prescription medication within 1 month prior to enrollment,

      9. Clinically significant abnormalities in vital signs at the time of screening defined by

        • Systolic BP >140 or <90 mmHg or diastolic BP >90 or <60 mmHg
        • Pulse <55 or >100 bpm
        • Respiratory Rate <9 or >20
        • Temperature >99 °F
    28. History of septic arthritis or sepsis/bacteremia in the affected knee within 6 months prior to screening, or infection requiring antibiotic treatment within the preceding 3 months.
    29. Women who are breastfeeding.
    30. Unwilling to use contraception for 3 months post procedure unless postmenopausal (for at least 2 years) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Micro Fragmented Adipose Tissue (MFat)

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
Intra-articular knee injection of Microfragmented Adipose Tissue (MFat) derived using the Lipogems® System.
Other Names:
  • MFat
Active Comparator: Saline Injection
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
Intra-articular knee injection of saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Western Ontario and McMaster Universities Osteoarthritis Index Pain (WOMAC-A) VA3.1 Score
Time Frame: 12-month visit
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
Time Frame: 12-month visit
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in WOMAC-A Pain Sub Score
Time Frame: 12-month visit
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A) Pain sub score at 6, 9 and 12-month follow-up visits compared to baseline, Scale 1-100, where 100 is extreme pain.
12-month visit
Change in Total WOMAC scores
Time Frame: 12-month visit
Change in Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at, 6, 9, and 12-month follow-up visits compared to baseline; Scale 1-100, where 100 is either extreme pain (WOMAC-A), extreme stiffness (WOMAC-B) or extreme difficulty performing a function (WOMAC-C).
12-month visit
Change in WOMAC-C Pain Sub Score
Time Frame: 12-month visit
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-C) Function sub score at 6, 9, and 12-month follow-up visits compared to baseline; Scale 1-100, where 100 is extreme difficulty performing a function
12-month visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lipogems International spa

Collaborators

Alira Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIPO-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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