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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526898
• Other study ID #: SHT-SYN-03
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Syntr Health Technologies, Inc.
• Contact: Ahmed Zobi, EMBA
• Phone: 949-992-5728
• Email: info[@]syntrhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• SyntrFuge System
Microsized Adipose Tissue

Drug:
• Triamcinolone Injection
Corticosteroid

Locations

Country	Name	City	State
United States	Irvine Site 1	Irvine	California
United States	Irvine Site 2	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Syntr Health Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC	Change of WOMAC Score from Baseline	6 months, 12 months, 24 months
Secondary	Knee Injury and Osteoarthritis Outcomes Score (KOOS)	Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time	6 months, 12 months, 24 months
Secondary	Single Assessment Numerical Evaluation	Change in Single Assessment Numerical Evaluation (SANE) Over Time	6 months, 12 months, 24 months