RECRUITING

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

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Conditions

Knee OsteoarthritisMicrosized Fat TissueAdipose TissueFat TransferOrthopedic Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05526898

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Subjects with previous traumatic lesion (tibial fracture, osteothomy) of the knee
  2. * Subjects with osteonecrosis
  3. * Subjects with meniscal surgery in the previous 6 weeks
  4. * Subjects with gout, hyperlipidemia
  5. * Subjects without decisional capacity
  6. * Subjects with inflammatory arthritis
  7. * Subjects with active infection
  8. * Subjects with any uncontrolled systemic disease
  9. * Subjects with a history of severe allergic/anaphylactic reactions or multiple allergies
  10. * Subjects planning to become pregnant, are pregnant, or are breast-feeding
  11. * Subjects with history or current evidence of drug or alcohol abuse within 36 months prior to screening visit
  12. * Subjects who have active autoimmune disease
  13. * Subjects who have coagulation disorders
  14. * Subjects who have received any other therapy, which, in the opinion of the investigator, could interfere with safety or efficacy evaluations
  15. * 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
  16. * Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
  17. * 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
  18. * Subjects who have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.
  19. * No intra-articular injection of corticosteroids within the last 24 weeks
  20. * No intra-articular injection of any other cellular therapy within the last 24 weeks

Contacts and Locations

Study Contact

Ahmed Zobi, EMBA
CONTACT
949-992-5728
info@syntrhealth.com

Study Locations (Sites)

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

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-10-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Microsized Fat Tissue
  • Adipose Tissue
  • Fat Transfer
  • Knee Osteoarthritis
  • Orthopedic Surgery

Additional Relevant MeSH Terms

  • Knee Osteoarthritis