Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
NCT ID: NCT05526898
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
176 participants
INTERVENTIONAL
2024-10-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SyntrFuge System
Adipose tissue microsized via the SyntrFuge System
SyntrFuge System
Microsized Adipose Tissue
Standard of Care
Steroid Injection
Triamcinolone Injection
Corticosteroid
Interventions
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SyntrFuge System
Microsized Adipose Tissue
Triamcinolone Injection
Corticosteroid
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
Yes
Sponsors
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Syntr Health Technologies, Inc.
INDUSTRY
Responsible Party
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Locations
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Irvine Site 1
Irvine, California, United States
Irvine Site 2
Irvine, California, United States
Countries
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Central Contacts
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Other Identifiers
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SHT-SYN-03
Identifier Type: -
Identifier Source: org_study_id
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