Autologous Adipose Cells Therapy

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age21-80
SponsorCERM INC.

About this trial

Autologous Adipose Cell Therapy is a series of process designated to address the demerits of the traditional autologous fat grafting and dermal fillers, while enhancing the versatility and aesthetic outcomes. In this study, the goal is to evaluate the safety and efficacy of Autologous Adipose cell Therapy for skin rejuvenation and hair improvement in human application.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Outpatients who express interest in skin rejuvenation, and/or who are experiencing skin conditions, such as winkles, fine lines, loss of skin elasticity, skin pigmentation, scarring.

Outpatients who are experiencing hair loss or hair thinning

Provision of signed and dated informed consent form

Clearly stated willingness to comply with all the procedures of the study and availability of the study

Disqualifiers

Pregnancy or lactation

Known allergic reaction to components of cell culture media

Chronic disease , e.g. cardiovascular disease, diabetes, chronic kidney disease, seizures

Chronic infections, e.g. skin fungi infection, psoriasis

Trial design

Design model

Single group

Treatments tested in this trial

  • Autologous Adipose Cells Therapy

    Biological/Vaccine

    Participants will receive Autologous Adipose Cells therapy treatment, and the safety and efficacy of the treatment will be monitored by the primary investigator up to 25 weeks.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Autologous Adipose Cells TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Outcome Comparison Survey

30 people will be randomly selected to rank the level of improvement by comparing the images captured at pro and post-treatment from Imaging assessment. Scale of Improvement: * No Improvement(0%) * Minimal Improvement(1% - 25%) * Moderate Improvement(26% - 50%) * Significant Improvement(51% - 75%) * Major Improvement(76% - 100%)

Time frame
The end of the study (Week 20 to 25)
2

Participant Satisfaction Survey

Participants will be requested to complete a list of questions related to their experience and satisfaction of autologous adipose cell therapy in each study visit for result evaluation. 1-to-5 Scales: * 1 being "very poor" and 5 being "excellent" * 1 being "very dissatisfied" and 5 being "very satisfied"

Time frame
From first post-treatment follow-up visit to the last follow-up visit at week 16 to week 25
3

Imaging Assessment

Digital images of the target site will be captured for each participant both prior to and following autologous adipose cell therapy for the purpose of outcome evaluation. The comparison of pre- and post-treatment images will be utilized in the "Outcome Comparison Survey" and the "Visit Evaluation Report" to assess the degree of improvement, based on the established assessment parameters for Autologous Adipose Cell Therapy treatment.

Time frame
From first pre-treatment visit to the last follow-up visit at week 16 to week 25
4

Case Report Form

A comprehensive medical document will be prepared by the responsible plastic surgeon which outlines the key details of each stage of the treatment process and aspects based on each participant's case. This document will include a thorough description of the patient's presenting medical conditions, the surgical procedures performed, post-treatment progress, any adverse events that occurred, and the final outcomes.

Time frame
The report will be completed at the end of the study (Week 20 to 25), but highlights would be recorded in this document during every visit.

Secondary outcomes

Other outcomes

Sponsors and contacts

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