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

Age

18–70

Sex

ALL

Healthy volunteers

Accepted

You may be eligible if

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

You may not be if

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

What this study is about