Fat Grafting for Facial Rejuvenation

Overseen By Steven Cohen, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sientra, Inc.

Must not be taking: Anticoagulants

Disqualifiers: Smoking, Bleeding disorders, Infections, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of facial fat grafting using the FDA-cleared Viality system. The research aims to understand the short- and long-term effects of transferring fat to the face for rejuvenation. Women who do not smoke and plan to undergo this cosmetic procedure may be suitable candidates, particularly if they can maintain their current weight during the study. As an unphased trial, it offers participants the chance to contribute to innovative cosmetic research and potentially improve their facial rejuvenation outcomes.

Do I have to stop taking my current medications for the trial?

The protocol does not specify if you need to stop taking your current medications, but you cannot participate if you are taking anticoagulants.

What prior data suggests that the Viality system is safe for facial fat grafting?

Research has shown that the Viality system, used for facial fat grafting, is generally well-tolerated. Studies have found that more than 80% of the transferred fat remains in place, suggesting that the procedure might be effective with fewer complications.

Reports of side effects exist, but these are common in any medical procedure. The FDA has approved the Viality system, indicating it meets safety standards for similar procedures. Prospective participants should discuss any concerns with a healthcare provider before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Viality for facial rejuvenation because it offers a unique approach to fat grafting. Unlike traditional methods, Viality uses a specialized wash system to process lipoaspirate, potentially enhancing the viability of the fat cells when transferred to the face. This could lead to more consistent and longer-lasting results compared to standard fat transfer techniques. By improving the quality of the graft, Viality aims to provide a more natural and effective option for facial rejuvenation.

What evidence suggests that the Viality system is effective for facial rejuvenation?

Research has shown that the Viality system, which participants in this trial will receive, helps maintain fat cell viability and placement during facial fat grafting. Early results indicate that over 80% of the transferred fat remains in place, achieving the desired appearance. The system improves fat cell survival, leading to better and more predictable outcomes. This suggests that Viality could be a reliable option for facial rejuvenation, making it a promising choice for those considering this treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

Sara Saul

Principal Investigator

Coordinator

Are You a Good Fit for This Trial?

This trial is for women aged 18-65 planning to undergo aesthetic fat grafting to the face. They must be non-smokers, able to maintain their weight, provide consent, and follow study procedures. Excluded are those with skin rashes, bleeding disorders, past facial trauma or surgery, infections, compromised immune systems, untreated substance abuse issues or who are pregnant/breastfeeding.

Inclusion Criteria

Patients must agree to maintain their weight (i.e. within 5%) by not making any major changes in diet or lifestyle during the study

I am having a cosmetic fat transfer to my face.

Patients must be non-smokers

Exclusion Criteria

Any issue that, at the discretion of the investigator, would contra-indicate the patient's participation

Untreated drug and/or alcohol abuse

I have had surgery or an injury in the area to be treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo autologous fat grafting to the face using the Viality system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for facial fat volume retention and safety after treatment

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Viality

Trial Overview

The trial studies the effects of using the Viality system in facial fat grafting. This FDA-cleared device will be used for tissue replacement and regeneration in patients' midfacial areas to assess both short-term and long-term outcomes.

How Is the Trial Designed?

Group I: Patients Receiving Lipoaspirate with Viality Experimental Treatment 1 Intervention

Patient will be undergoing fat transfers to the face with lipoaspirate processed using the Viality wash system.

Viality is already approved in United States for the following indications:

Approved in United States as Viality for:

• Aesthetic body contouring

Who Is Running the Clinical Trial?

Sientra, Inc.

Lead Sponsor

Trials

7

Recruited

7,600+

Tiger Biosciences, LLC.

Lead Sponsor

Trials

8

Recruited

8,000+

Faces+

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

The author has extensive experience (18 years) using fat transfer techniques, including pearl fat grafts and fat injections, for facial augmentation.

Pearl fat grafts are specifically used for delicate areas like eyelids and small depressions, while fat injections can enhance larger facial features such as the chin, cheekbones, and lips.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fat transfer: current use in practice. Ellenbogen, R.[2022]

Standardizing fat grafting techniques for facial rejuvenation can significantly improve clinical outcomes, as variability in methods can lead to less optimal results.

Using low negative pressure for fat harvesting, proper centrifugation for processing, and careful injection techniques can enhance graft survival and effectiveness, leading to more predictable and long-lasting results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fat Grafting for Facial Rejuvenation and Contouring: A Rationalized Approach. Pu, LLQ.[2019]

The novel Poloxamer Wash, Absorption, mesh filtration System (PWAS) resulted in a higher adipose volume fraction (89% ± 3%) compared to the Ringer's Lactate wash, Decant, and mesh filtration System (RLDS) (76% ± 10%), indicating better quality of processed lipoaspirate for fat grafting.

Both systems effectively removed oil and maintained similar cell viability and processing times, but the PWAS demonstrated superior efficiency in concentrating fat, making it a promising option for plastic surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Analysis of Two Automated Fat-processing Systems. An, Y., Panayi, AC., Mi, B., et al.[2022]

The study discusses a method for facial rejuvenation that involves using autogenous fat micrografts, which are harvested through a gentle syringe lipoaspiration technique, to restore lost volume due to aging.

Successful outcomes depend on careful handling of the fat micrografts to ensure proper vascularization and integration into the facial tissue, highlighting the importance of an atraumatic approach in the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rejuvenative facial lipomorphoplasty. Ho, LC.[2019]

A survey of 75 physicians treating 17,376 patients revealed that injection lipolysis has an excellent safety record, with no deaths or serious complications reported, such as infections or skin loss.

While most patients experienced positive outcomes, 12.34% expressed disappointment with their aesthetic results, highlighting the importance of educating patients about realistic expectations before treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety data and standards of practice for injection lipolysis: a retrospective study. Duncan, DI., Chubaty, R.[2022]

Fat grafting is a widely used method for facial rejuvenation, but its success depends on careful evaluation and treatment of both donor and recipient areas.

A thorough understanding of facial anatomy and personalized treatment approaches are crucial for achieving optimal results in fat grafting procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fat Grafting for Facial Rejuvenation in Asians. Yang, Z., Li, M., Jin, S., et al.[2022]

In a study of 145 patients over an average of 50 months, facial infiltrations with polyacrylamide hydrogel (Aquamid) showed a low incidence of severe complications, with only one patient experiencing a local infection, indicating long-term safety for treating facial lipoatrophy.

Patient satisfaction was high, with 88.9% reporting they were satisfied or very satisfied with the results, particularly those with mild to moderate lipoatrophy, suggesting that Aquamid is an effective option for facial lipoatrophy repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four-year safety with polyacrylamide hydrogel to correct antiretroviral-related facial lipoatrophy. Negredo, E., Puig, J., Aldea, D., et al.[2009]

The lipodissolution procedure using phosphatidylcholine solubilized with deoxycholate (PC/DC) was found to cause significant damage to subcutaneous tissue, including cell membrane lysis and reduced cell viability, in both rats and a human volunteer.

Histological analysis revealed that PC/DC treatment led to serious complications such as tissue fibrosis, fat necrosis, and vessel necrosis, raising concerns about the long-term safety of this cosmetic fat treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue-toxic effects of phosphatidylcholine/deoxycholate after subcutaneous injection for fat dissolution in rats and a human volunteer. Schuller-Petrovic, S., Wölkart, G., Höfler, G., et al.[2013]

The targeted fat-grafting technique for temporal hollowing augmentation was evaluated in a study of 96 patients, showing a high satisfaction rate of 91.7% and a significant improvement in appearance, with 74% of treated areas improving by more than 2 grades on the Hollowness Severity Rating Scale.

The technique demonstrated a fat graft survival rate of 65.7% and an overall augmentation rate of 91.4%, indicating both safety and efficacy in restoring volume to facial areas with low complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Outcomes of Temporal Hollowing Augmentation by Targeted Volume Restoration of Fat Compartments in Chinese Adults. Huang, RL., Xie, Y., Wang, W., et al.[2022]

Lipoinjection of autologous fat is an effective method to correct facial fat atrophy in HIV-positive patients using protease inhibitors, with satisfactory results observed over a 2-year period.

In about 30% of cases, patients required a reinjection of fat within the first few months after the initial procedure, indicating the need for potential follow-up treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of facial fat atrophy related to treatment with protease inhibitors by autologous fat injection in patients with human immunodeficiency virus infection. Serra-Renom, JM., Fontdevila, J.[2022]

A study of 17 female patients (average age 61) showed that combining autologous fat grafting with CO2 laser resurfacing significantly improved the appearance of fine wrinkles, deep folds, and pigmentation in the lower face, with p-values indicating strong statistical significance.

No complications were reported from the procedure, although one patient experienced resorption of the fat graft, suggesting that the treatment is generally safe and effective for facial rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent structural fat grafting and carbon dioxide laser resurfacing for perioral and lower face rejuvenation. Ransom, ER., Antunes, MB., Bloom, JD., et al.[2022]

Citations

1.

tiger-aesthetics.com

tiger-aesthetics.com/wp-content/uploads/2024/12/MDC-0914-R2-Sientra-Viality-White-Paper.pdf

preliminary results from the prospective

The preliminary results support the effectiveness of Enhanced Viability Fat Transfer with the Viality system as average volume retentions were greater than 80% ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11249923/

Improving the Retention of Low-Volume Autologous Fat ...

The authors in this study aimed to compare PWAS technology with traditional lipoaspirate processing techniques in low-volume fat grafting procedures.

3.

trialx.com

trialx.com/clinical-trials/listings/259827/autologous-fat-grafting-to-the-face-with-use-of-the-vialitytm-system/

Autologous Fat Grafting to the Face With Use of the Viality ...

The purpose of this research is to collect data on the short and long-term effects of facial fat grafting by injectable tissue replacement and regeneration.

4.

tiger-aesthetics.com

tiger-aesthetics.com/regenerative-aesthetics-products/viality-enhanced-viability-fat-transfer/

Viality Enhanced Viability Fat Transfer

Viality by Tiger Aesthetics can further enhance the viability and survival of the transferred fat cells, resulting in better outcomes, with predictable results.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4102616/

Studies in Fat Grafting: Part I. Effects of Injection Technique ...

Results. Fat viability and cellular proliferation were both significantly greater with the Adipose Tissue Injector relative to injection with the modified ...

6.

accessdata.fda.gov

accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=17097881&pc=QKL

SIENTRA INC. VIALITY¿ LIPOASPIRATE WASH SYSTEM

MAUDE Adverse Event Report: SIENTRA INC. VIALITY¿ LIPOASPIRATE WASH SYSTEM; FAT TRANSFER ; 06/09/2023 · 08/20/2023 · 08/25/2023 · Yes.

7.

sientra.com

sientra.com/wp-content/uploads/2023/08/IFU-0024-R3-Viality-Lipoaspirate-Wash-System-IFU-v1.pdf

lipoaspirate wash system

Safety Information. CONTRAINDICATIONS. Contraindications to autologous fat transfer include the presence of any disease processes that adversely affect wound.