SyntrFuge™ Processed Fat Grafting for Facial Atrophy

Recruiting at 1 trial location

Overseen By Ahmed Zobi, EMBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Syntr Health Technologies, Inc.

Must not be taking: Anticoagulants, NSAIDs, Immunosuppressants, others

Disqualifiers: Uncontrolled systemic disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open label multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in facial aesthetics and contouring. 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.

Will I have to stop taking my current medications?

The trial requires you to stop taking anti-coagulation, anti-platelet, or thrombolytic medications, as well as anti-inflammatory drugs like aspirin or ibuprofen, from 10 days before to 3 days after the injection. There is a 10-day washout period for these medications.

What data supports the effectiveness of the treatment SyntrFuge System, Autologous Microsized Adipose Tissue Therapy for facial atrophy?

Research shows that using fat grafting, like the SyntrFuge System, can be effective for facial atrophy, as it provides a natural and long-lasting way to restore facial volume. Studies have found that fat grafting works well in areas with fat loss, such as the cheeks and around the eyes, and patients report high satisfaction with the cosmetic results. ^{1 2 3 4 5}

Is SyntrFuge™ Processed Fat Grafting for Facial Atrophy safe?

Autologous fat grafting, which includes techniques like SyntrFuge, is generally considered safe for facial soft tissue augmentation, with studies showing good cosmetic results and minimal complications. However, the long-term results can be unpredictable, and additional treatments may be needed. ^{1 2 6 7 8}

How is the SyntrFuge System treatment different from other treatments for facial atrophy?

The SyntrFuge System treatment is unique because it uses a specialized process to prepare fat tissue for grafting, which may enhance the retention and integration of the fat in the face, providing a more natural and long-lasting result compared to traditional methods. This approach avoids visible scars and can be performed in multiple stages if needed, offering flexibility and improved aesthetic outcomes. ^{1 2 3 5 9}

Eligibility Criteria

This trial is for adults aged 18-70 seeking facial fat grafting without severe allergies, uncontrolled diseases, or recent cosmetic procedures in the area. Participants must not be pregnant or planning pregnancy and should avoid other facial treatments during the study.

Inclusion Criteria

I am between 18 and 70 years old.

I am not pregnant or breastfeeding.

I can walk on my own without help.

Exclusion Criteria

Subjects with a history of severe allergic/anaphylactic reactions or multiple allergies

I am unable to understand and sign the consent form.

I am unable to make my own medical decisions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous microsized adipose tissue in the treatment sites

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person)

Treatment Details

Interventions

• SyntrFuge System

Trial Overview The SyntrFuge™ System is being tested for its effectiveness in processing adipose tissue for improving facial aesthetics. Patients will receive injections of their own processed fat into targeted areas of their face.

Participant Groups

Group I: SyntrFuge System Experimental Treatment 1 Intervention

Adipose tissue microsized via the SyntrFuge System

Who Is Running the Clinical Trial?

Syntr Health Technologies, Inc.

Lead Sponsor

Trials

3

Recruited

240+

References

1. England pubmed.ncbi.nlm.nih.gov

Techniques in facial fat grafting. [2022]

2. Ukraine pubmed.ncbi.nlm.nih.gov

[POSSIBILITIES OF THE FAT TISSUE TRANSPLANTATION FOR THE FACE ATROPHY OF VARIOUS ETIOLOGY]. [2022]

3. Scotland pubmed.ncbi.nlm.nih.gov

Clinical evaluation of techniques used in the surgical treatment of progressive hemifacial atrophy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

High-Density Fat Grafting Assisted Stromal Vascular Fraction Gel in Facial Deformities. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Parry-Romberg reconstruction: beneficial results despite poorer fat take. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Autologous Fat Transfer Harvest-site Complications: Incidence, Risk Factors, and Management. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Sustained Overcorrection After Autologous Facial Fat Grafting in the Pediatric Population: A Case Series. [2018]

8. Denmark pubmed.ncbi.nlm.nih.gov

[Hemifacial atrophy treated with lipofilling]. [2019]

9. India pubmed.ncbi.nlm.nih.gov

Comparison of fat maintenance in the face with centrifuge versus filtered and washed fat. [2022]