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

Phase 3

Completed

• Conditions: Knee Osteoarthritis; Osteo Arthritis Knee
• Interventions: Drug: Corticosteroid; Device: Microfragmented Adipose Tissue

• Registration Number: NCT05660772
• Lead Sponsor: Lipogems International spa

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.

Detailed Description

This study will investigate The Lipogems System in a clinical study to examine the effect of micro fragmented adipose tissue processed using The Lipogems System in comparison to corticosteroid 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 Timeline

• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-21
• Study Start: 2022-12-30
• Status Verified: 2025-04
• Primary Completion: 2025-04-09
• Study Completion: 2025-04-09
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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:

     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 for the past 3 months prior to enrollmentat 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. Known hypersensitivity/contraindication to corticosteroid injections.

  19. Diagnosis of coagulation disorders (e.g., Von Willebrand's disease) and/or currently on anti-coagulant therapy.

  20. Occurrence of knee trauma to the index knee within six months prior to screening.

  21. 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.

  22. 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.

  23. 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.

  24. Currently taking prescription pain medication for a condition other than the index knee.

  25. Currently in prison.

  26. 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).

  27. Impossibility to harvest enough adipose tissue.

  28. 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

  29. 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.

  30. Women who are breastfeeding.

  31. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid Injection	Corticosteroid	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.
Microfragmented Adipose Tissue (Mfat)	Microfragmented Adipose Tissue	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.

Primary Outcome Measures

Name	Time	Method
Change in Western Ontario and McMaster Universities Osteoarthritis Index Pain (WOMAC-A) VA3.1 Score	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
WOMAC-C Subscale Score	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.

Secondary Outcome Measures

Name	Time	Method
Change in WOMAC-C Function Sub Score	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
Change in Total WOMAC scores	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).
Change in WOMAC-A Pain Sub Score	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.

Trial Locations

Locations (18)

Pinnacle Trials, Inc; 🇺🇸 Atlanta, Georgia, United States

All American Ortho; 🇺🇸 Houston, Texas, United States

Stanford University; 🇺🇸 Redwood City, California, United States

The Orthopedic Center; 🇺🇸 Tulsa, Oklahoma, United States

Cincinnati Sports Medicine and Orthopaedic Center; 🇺🇸 Cincinnati, Ohio, United States

Andrews Research & Education Foundation; 🇺🇸 Gulf Breeze, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Texas Center for Cell Therapy and Research, LLC; 🇺🇸 San Antonio, Texas, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

University of Iowa Sports Medicine; 🇺🇸 Iowa City, Iowa, United States

San Antonio Orthopedics; 🇺🇸 San Antonio, Texas, United States

Northwell Health; 🇺🇸 New York, New York, United States

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

CORE Orthopaedic Center; 🇺🇸 Encinitas, California, United States

Columbia University; 🇺🇸 Tarrytown, New York, United States

Ohio Health Research Institute; 🇺🇸 Columbus, Ohio, United States

Emory University; 🇺🇸 Brookhaven, Georgia, United States

Regenerative Orthopedics and Sports Medicine (ROSM); 🇺🇸 North Bethesda, Maryland, United States