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NCT05526898 | RECRUITING | Knee Osteoarthritis

Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
Sponsor:

Syntr Health Technologies, Inc.

Brief Summary:

This is an multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in Orthopedic Surgery, specifically Knee Osteoarthritis. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous microsized adipose tissue in the treatment sites or Standard of Care.

Condition or disease

Knee Osteoarthritis

Intervention/treatment

SyntrFuge System

Triamcinolone Injection

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 176 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Multi-Center, Randomized Controlled Trial Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
Actual Study Start Date : 2024-10-01
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Subjects aged of 35-80 years old
  • * Patients with knee osteoarthritis grade II, III, and IV Kellgren-Lawrence
  • * Chronic knee pain or symptoms for at least 3 months
  • * BMI between 20 and 34.9
  • * Willing and able to read and sign the informed consent and other study materials
  • * Written informed consent has been obtained prior to any study-related procedures
  • * Written Authorization for Use and Release of Health and Research Study Information has been signed
  • * Subjects are ambulatory
  • * Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study
  • * Females of childbearing potential must have a negative urine pregnancy test result and not be lactating
  • * Subject is in good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the Investigator's opinion, exposes the Subject to an unacceptable risk by study participation
    • Exclusion Criteria
    • * Subjects with previous traumatic lesion (tibial fracture, osteothomy) of the knee
    • * Subjects with osteonecrosis
    • * Subjects with meniscal surgery in the previous 6 weeks
    • * Subjects with gout, hyperlipidemia
    • * Subjects without decisional capacity
    • * Subjects with inflammatory arthritis
    • * Subjects with active infection
    • * Subjects with any uncontrolled systemic disease
    • * Subjects with a history of severe allergic/anaphylactic reactions or multiple allergies
    • * Subjects planning to become pregnant, are pregnant, or are breast-feeding
    • * Subjects with history or current evidence of drug or alcohol abuse within 36 months prior to screening visit
    • * Subjects who have active autoimmune disease
    • * Subjects who have coagulation disorders
    • * Subjects who have received any other therapy, which, in the opinion of the investigator, could interfere with safety or efficacy evaluations
    • * Subjects with current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
    • * Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
    • * Subjects who have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 7 days pre- to 3 days post injection. A wash out period of 7 days is allowed
    • * Subjects who have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.
    • * No intra-articular injection of corticosteroids within the last 24 weeks
    • * No intra-articular injection of any other cellular therapy within the last 24 weeks
    Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis

    Location Details

    NCT05526898

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, California

    Irvine Site 1

    Irvine, California, United States, 92618

    RECRUITING

    United States, California

    Irvine Site 2

    Irvine, California, United States, 92618