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

Running, not enrolling · Phase 3

Conditions studied: Knee Osteoarthritis, Osteo Arthritis Knee

In brief

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.

Key facts

Study ID

NCT06121882

Run by

Lipogems International spa

People needed

173

Starts

2024-03-15

Expected to finish

2025-06-23

Last updated by the study team

2025-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
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• 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.
• 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.
• 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.

Where it is running

• Arizona Bone, Joint and Sports Medicine Center LLC — Phoenix, Arizona, United States
• CORE Orthopaedic Medical Center — Encinitas, California, United States
• Horizon Clinical Research — La Mesa, California, United States
• Andrews Research & Ed Foundation — Gulf Breeze, Florida, United States
• Hospital for Special Surgery Florida — West Palm Beach, Florida, United States
• Pinnacle Trials, Inc — Atlanta, Georgia, United States
• Fascia Institute and Treatment (FIT) Center — Metairie, Louisiana, United States
• Ochsner Sports Medicine Institute — New Orleans, Louisiana, United States
• Regenerative Orthopedics & Sports Medicine — Rockville, Maryland, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• The Orthopedic Center - NextStage Clinical Research - Tulsa — Tulsa, Oklahoma, United States
• LeHigh Center for Clinical Research — Allentown, Pennsylvania, United States
• Coastal Carolina Research Center — North Charleston, South Carolina, United States
• Vanderbilt Orthopaedics — Nashville, Tennessee, United States
• All American Ortho - NextStage Clinical Research — Houston, Texas, United States
• Texas Center for Cell Therapy and Research, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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