Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SyntrFuge System
Triamcinolone Injection
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Microsized Fat Tissue, Adipose Tissue, Fat Transfer, Knee Osteoarthritis, Orthopedic Surgery
Eligibility 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
Sites / Locations
- Irvine Site 1Recruiting
- Irvine Site 2Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
SyntrFuge System
Standard of Care
Arm Description
Adipose tissue microsized via the SyntrFuge System
Steroid Injection
Outcomes
Primary Outcome Measures
WOMAC
Change of WOMAC Score from Baseline
Secondary Outcome Measures
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time
Single Assessment Numerical Evaluation
Change in Single Assessment Numerical Evaluation (SANE) Over Time
Full Information
NCT ID
NCT05526898
First Posted
August 31, 2022
Last Updated
September 1, 2022
Sponsor
Syntr Health Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05526898
Brief Title
Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
Official Title
Multi-Center, Randomized Controlled Trial Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Syntr Health Technologies, Inc.
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Microsized Fat Tissue, Adipose Tissue, Fat Transfer, Knee Osteoarthritis, Orthopedic Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
176 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SyntrFuge System
Arm Type
Experimental
Arm Description
Adipose tissue microsized via the SyntrFuge System
Arm Title
Standard of Care
Arm Type
Other
Arm Description
Steroid Injection
Intervention Type
Device
Intervention Name(s)
SyntrFuge System
Intervention Description
Microsized Adipose Tissue
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Injection
Intervention Description
Corticosteroid
Primary Outcome Measure Information:
Title
WOMAC
Description
Change of WOMAC Score from Baseline
Time Frame
6 months, 12 months, 24 months
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Description
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time
Time Frame
6 months, 12 months, 24 months
Title
Single Assessment Numerical Evaluation
Description
Change in Single Assessment Numerical Evaluation (SANE) Over Time
Time Frame
6 months, 12 months, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Zobi, EMBA
Phone
949-992-5728
Email
info@syntrhealth.com
Facility Information:
Facility Name
Irvine Site 1
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Recruiting
Facility Name
Irvine Site 2
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
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