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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05526898
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Syntr Health Technologies, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Knee Osteoarthritis
Arms & Interventions

Arms

Experimental: SyntrFuge System

Adipose tissue microsized via the SyntrFuge System

Other: Standard of Care

Steroid Injection

Interventions

Device: - SyntrFuge System

Microsized Adipose Tissue

Drug: - Triamcinolone Injection

Corticosteroid

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Irvine Site 1, Irvine, California

Status

Recruiting

Address

Irvine Site 1

Irvine, California, 92618

Irvine Site 2, Irvine, California

Status

Recruiting

Address

Irvine Site 2

Irvine, California, 92618

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