Autologous Adipose Cells Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Autologous Adipose Cells Therapy: 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.

Study summary

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

Primary outcome measure(s)

• Outcome Comparison Survey — The end of the study (Week 20 to 25)
  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%)
• Participant Satisfaction Survey — From first post-treatment follow-up visit to the last follow-up visit at week 16 to week 25
  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"
• Imaging Assessment — From first pre-treatment visit to the last follow-up visit at week 16 to week 25
  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.
• Case Report Form — 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.
  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.
• Visit Evaluation Report — From first post-treatment follow-up visit to the last follow-up visit at week 16 to week 25
  During each post-treatment visit, the responsible plastic surgeon will assess the treatment outcomes and evaluate the degree of improvement by comparing the pre-treatment image with the current post-treatment image. Scale of Improvement: * No Improvement(0%) * Minimal Improvement(1% - 25%) * Moderate Improvement(26% - 50%) * Significant Improvement(51% - 75%) * Major Improvement(76% - 100%) Assessment Parameters: Skin: * Radiance * Texture * Firmness * Wrinkles \& Fine Lines * Spot Hyperpigmentation * Tone * Redness \& Inflammation * Pore Size Hair: * Density * Thickness * Visual Appearance * Texture (Smoothness \& Frizz Control) * Shine * Scalp Health

Trial sites (2)

Other trials for the same condition