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Knee OsteoarthritisPhase 3ARISE2NCT06121882

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

A Phase 3 study testing Microfragmented Adipose Tissue derived using the Lipogems® System and Saline Injection in people with Knee Osteoarthritis and Osteo Arthritis Knee, run by Lipogems International spa at 16 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Knee Osteoarthritis, Osteo Arthritis Knee
What is being tested?
Microfragmented Adipose Tissue derived using the Lipogems® System and Saline Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
16 sitesUnited States
Study dates
15 Mar 2024to 23 Jun 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • CONFIDENTIAL Page 12 of 52 Version 2.0, 10JUL2023
  • 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.
  • 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)

Who cannot join

  • 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.
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  • 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.
  • Use of oral systemic corticosteroids within the last 90 days and for the duration of the study.
  • History of any chemotherapy or radiation therapy of the targeted/treatment leg or adipose harvest site.
  • Active worker's compensation case.
  • Diagnosis of coagulation disorders (e.g., Von Willebrand's disease) and/or currently on anti-coagulant therapy.
  • Occurrence of knee trauma to the index knee within six months prior to screening.
  • 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.
  • 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.
  • 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.
  • Currently taking prescription pain medication for a condition other than the index knee.
  • Currently in prison.
  • 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).
  • Impossibility to harvest enough adipose tissue.
  • Any medical issue that the clinician feels would be a contraindication to the study treatment including, but not limited to:
  • Uncontrolled diabetes defined as HbA1c >7%,
  • History of uncontrolled hypertension defined by average systolic BP >140 mmHg or diastolic BP > 90 mmHg on ≥ 3 blood pressure medications,
  • History of cardiovascular disease,
  • History of cerebrovascular disease,
  • Uncontrolled asthma, defined as symptomatic (i.e., shortness of breath and/or wheezing) despite therapy,
  • History of solid organ or hematologic transplantation,
  • Diagnosis of non-basal cell malignancy within preceding 5 years,
  • Change in prescription medication within 1 month prior to enrollment,
  • 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
  • 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.
  • Women who are breastfeeding.
  • 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).

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • LeHigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Pinnacle Trials, Inc

    Atlanta, Georgia, 30327

  • CORE Orthopaedic Medical Center

    Encinitas, California, 92024

  • Andrews Research & Ed Foundation

    Gulf Breeze, Florida, 32561

  • All American Ortho - NextStage Clinical Research

    Houston, Texas, 77058

  • Horizon Clinical Research

    La Mesa, California, 91942

  • Fascia Institute and Treatment (FIT) Center

    Metairie, Louisiana, 70001

  • Vanderbilt Orthopaedics

    Nashville, Tennessee, 37209

  • Ochsner Sports Medicine Institute

    New Orleans, Louisiana, 70121

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Arizona Bone, Joint and Sports Medicine Center LLC

    Phoenix, Arizona, 85012

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Regenerative Orthopedics & Sports Medicine

    Rockville, Maryland, 20852

  • Texas Center for Cell Therapy and Research, LLC

    San Antonio, Texas, 78240

  • The Orthopedic Center - NextStage Clinical Research - Tulsa

    Tulsa, Oklahoma, 74104

  • Hospital for Special Surgery Florida

    West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Microfragmented Adipose Tissue derived using the Lipogems® System, Saline Injection
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microfragmented Adipose Tissue derived using the Lipogems® SystemDevice

    Also called MFat

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

  • Saline InjectionDrug

    Intra-articular knee injection of saline

Study groups in NCT06121882
Study groupRoleWhat they receive
Micro Fragmented Adipose Tissue (MFat)ExperimentalInjection 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.
Receives: Device: Microfragmented Adipose Tissue derived using the Lipogems® System
Saline InjectionActive comparatorThe 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.
Receives: Drug: Saline Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12-month visit

  2. 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.

    Measured: 12-month visit

Secondary outcomes (3)

  1. Change in WOMAC-A Pain Sub Score

    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.

    Measured: 12-month visit

  2. Change in WOMAC-C Pain Sub Score

    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

    Measured: 12-month visit

  3. Change in Total WOMAC scores

    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).

    Measured: 12-month visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2023
  2. Study start15 Mar 2024
  3. Primary completion23 Jun 2025 (estimated)
  4. Study completion23 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06121882
Sponsor's protocol ID
LIPO-002
Acronym
ARISE2
Status last verified
Jun 2025
First submitted
2 Nov 2023
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Microfragmented Adipose Tissue derived using the Lipogems® System and Saline Injection in people with Knee Osteoarthritis and Osteo Arthritis Knee, run by Lipogems International spa at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Western Ontario and McMaster Universities Osteoarthritis Index Pain (WOMAC-A) VA3.1 Score (time frame: 12-month visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06121882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

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