Evaluating the effect of processed fat tissue for knee osteoarthritis
Multi-Center, Randomized Controlled Trial Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
NA · Syntr Health Technologies, Inc. · NCT05526898
This study is testing whether injections of processed fat tissue can help people with knee osteoarthritis feel better compared to standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Syntr Health Technologies, Inc. (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Irvine, California and 1 other locations) |
| Trial ID | NCT05526898 on ClinicalTrials.gov |
What this trial studies
This multi-center study aims to assess the efficacy of adipose tissue processed with the SyntrFuge™ system in treating knee osteoarthritis. Patients will receive injections of autologous microsized adipose tissue at the treatment sites, compared to standard care. The study focuses on individuals with chronic knee pain and varying grades of osteoarthritis. Participants will be monitored for their response to the treatment over the course of the study.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 35-80 with grade II, III, or IV knee osteoarthritis and chronic knee pain.
Not a fit: Patients with systemic diseases or conditions that could impair evaluation or pose risks from participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from knee osteoarthritis.
How similar studies have performed: Other studies have explored similar fat transfer techniques, showing promising results, but this specific approach with the SyntrFuge™ system is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Irvine, California and 1 other locations
- Irvine Site 1 — Irvine, California, United States (RECRUITING)
- Irvine Site 2 — Irvine, California, United States (RECRUITING)
Study contacts
- Study coordinator: Ahmed Zobi, EMBA
- Email: info@syntrhealth.com
- Phone: 949-992-5728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Osteoarthritis, Microsized Fat Tissue, Adipose Tissue, Fat Transfer, Orthopedic Surgery