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

April 15, 2024 updated by: Syntr Health Technologies, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92618
        • Recruiting
        • Irvine Site 1
      • Irvine, California, United States, 92618
        • Recruiting
        • Irvine Site 2

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.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SyntrFuge System
Adipose tissue microsized via the SyntrFuge System
Device: SyntrFuge System
Microsized Adipose Tissue
Other: Standard of Care
Steroid Injection
Drug: Triamcinolone Injection
Corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC
Time Frame: 6 months, 12 months, 24 months
Change of WOMAC Score from Baseline
6 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Time Frame: 6 months, 12 months, 24 months
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time
6 months, 12 months, 24 months
Single Assessment Numerical Evaluation
Time Frame: 6 months, 12 months, 24 months
Change in Single Assessment Numerical Evaluation (SANE) Over Time
6 months, 12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syntr Health Technologies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHT-SYN-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on SyntrFuge System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe