Evaluating the effect of processed fat tissue for knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center study aims to assess the efficacy of adipose tissue processed with the SyntrFuge™ system in treating knee osteoarthritis. Patients will receive injections of autologous microsized adipose tissue at the treatment sites, compared to standard care. The study focuses on individuals with chronic knee pain and varying grades of osteoarthritis. Participants will be monitored for their response to the treatment over the course of the study.

Why it matters

Who can join: the full rules

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

Where it's running

• Irvine Site 1
  Irvine, California, United States Recruiting
• Irvine Site 2
  Irvine, California, United States Recruiting

Study contacts

• Study coordinator: Ahmed Zobi, EMBA
• Email: info@syntrhealth.com
• Phone: 949-992-5728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.