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

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Triamcinolone Injection; Device: SyntrFuge System

• Registration Number: NCT05526898
• Lead Sponsor: Syntr Health Technologies, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Study Start: 2024-10-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Triamcinolone Injection	Steroid Injection
SyntrFuge System	SyntrFuge System	Adipose tissue microsized via the SyntrFuge System

Primary Outcome Measures

Name	Time	Method
WOMAC	6 months, 12 months, 24 months	Change of WOMAC Score from Baseline

Secondary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcomes Score (KOOS)	6 months, 12 months, 24 months	Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time
Single Assessment Numerical Evaluation	6 months, 12 months, 24 months	Change in Single Assessment Numerical Evaluation (SANE) Over Time

Trial Locations

Locations (2)

Irvine Site 1; 🇺🇸 Irvine, California, United States

Irvine Site 2; 🇺🇸 Irvine, California, United States