SyntrFuge™ Processed Fat Grafting for Facial Atrophy

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if the SyntrFuge System (Autologous Microsized Adipose Tissue Therapy) can enhance facial appearance using a person’s own fat. Participants will receive injections of their own fat, processed in a novel way, to aid in facial contouring. The trial seeks individuals who have experienced noticeable facial thinning or volume loss and have not recently undergone cosmetic treatments like fillers or lasers. Those with conditions such as facial atrophy who have not had recent cosmetic procedures may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore innovative treatments for facial volume loss.

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 prior data suggests that the SyntrFuge System is safe for facial atrophy treatment?

Research shows that systems like SyntrFuge for fat grafting are generally well-tolerated. Previous studies on using a patient's own fat for facial procedures have demonstrated this method's safety. Evidence indicates that the SyntrFuge System maintains the health of fat cells, which is crucial for effective and safe treatment.

Reports of negative reactions are rare, and available data suggests they are minimal. Since this method is already used in other facial procedures, it provides some confidence in its safety. However, because this study is in an early phase, monitoring for potential risks or side effects during the trial remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for facial atrophy that often involve synthetic fillers or surgical interventions, the SyntrFuge System uses a unique approach by processing a patient’s own adipose (fat) tissue. This method microsizes the tissue, potentially offering a more natural and biocompatible option for facial restoration. Researchers are excited because this technique might reduce the risk of rejection and provide a longer-lasting, more natural appearance compared to existing options.

What evidence suggests that the SyntrFuge System is effective for facial atrophy?

Research shows that the SyntrFuge System has produced positive results for treating facial atrophy, which involves a loss of volume in the face. One study found it effectively restored volume in the cheeks and the lines from the nose to the mouth (nasolabial folds). In this trial, participants will receive treatment with the SyntrFuge System. Previous studies indicate that 82% of patients reported being very satisfied or somewhat satisfied with their results. The SyntrFuge System is also FDA cleared, meaning it has undergone review for safety and effectiveness. These findings suggest that the system could be a promising option for improving facial shape and appearance. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 not pregnant or breastfeeding.

I can walk on my own without help.

Willing and able to read and sign the informed consent and other study materials

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

withpower.com

withpower.com/trial/syntrfuge-processed-fat-grafting-for-facial-atrophy-f5f83

SyntrFuge™ Processed Fat Grafting for Facial Atrophy

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 ...

2.

withpower.com

withpower.com/trial/phase-facies-8-2022-f5f83?lat=36.65114&lng=-97.3517

SyntrFuge™ Processed Fat Grafting for Facial Atrophy

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 ...

3.

biospace.com

biospace.com/syntr-health-technologies-announces-positive-data-from-facial-fat-transfer-clinical-study-using-their-fda-cleared-syntrfuge-system

Syntr Health Technologies, Inc. announces positive ...

The multi-center study achieved primary endpoints of correction of moderate-to-severe mid-face (Cheeks) and nasolabial folds (NLF) volume deficit.

4.

syntrhealth.com

syntrhealth.com/

Syntr | The World's Only Automated Fat Processing System ...

The SyntrFuge System is FDA cleared and offers the only automated method of comprising autologous microfat on the market. Sign up to become a partner today.

5.

prnewswire.com

prnewswire.com/news-releases/syntr-health-technologies-announces-positive-data-from-facial-fat-transfer-clinical-study-using-their-fda-cleared-syntrfuge-system-301806144.html

SYNTR HEALTH TECHNOLOGIES ANNOUNCES ...

After receiving treatment to the cheeks and nasolabial folds, 82% of patients reported being very satisfied or somewhat satisfied with their ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05522426

Study Details | NCT05522426 | Open Label, Multi-Center ...

Open Label, Multi-Center Study, Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Facial Fat Grafting ; ClinicalTrials.gov ID ...

7.

ctv.veeva.com

ctv.veeva.com/study/open-label-multi-center-study-evaluating-the-effect-of-adipose-tissue-processed-with-the-syntrfuge

Open Label, Multi-Center Study, Evaluating the Effect of ...

Follow trial. Open Label, Multi-Center Study, Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Facial Fat ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12206044/

Autologous adipose tissue transfer in progressive ...

Autologous adipose tissue transfer in progressive hemifacial atrophy: From simple volume to regenerative cell therapy. ML Foba. ML Foba. a ...

9.

journals.sagepub.com

journals.sagepub.com/doi/abs/10.1177/27325016241238441

Autologous Fat Transfer in Craniofacial Surgery

Effects of a new centrifugation method on adipose cell viability for autologous fat grafting. Aesthetic Plast Surg. 2011;35(3):341-348. Crossref.