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

Description

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.

Conditions

Knee Osteoarthritis

Study Overview

Study Details

Study overview

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.

Multi-Center, Randomized Controlled Trial Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis

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

Condition
Knee Osteoarthritis
Intervention / Treatment

-

Contacts and Locations

Irvine

Irvine Site 1, Irvine, California, United States, 92618

Irvine

Irvine Site 2, Irvine, California, United States, 92618

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Syntr Health Technologies, Inc.,

Study Record Dates

2025-12