Autologous Adipose Cells Therapy for Skin Rejuvenation and Hair Improvement
This study is testing a treatment called Autologous Adipose Cells Therapy for people experiencing hair loss, baldness, wrinkles, fine lines, and reduced skin elasticity. This therapy uses your own fat cells to improve skin and hair, aiming to be more effective and longer-lasting than traditional methods like dermal fillers or unprocessed fat grafts. Researchers want to see how safe and effective this treatment is. They will measure success by looking at surveys about your satisfaction and the treatment's outcome, as well as imaging assessments. The study plans to enroll 40 participants aged 21 to 80 years old who are interested in skin rejuvenation or have hair loss.
- Study design
- This is an interventional study, meaning participants will receive the Autologous Adipose Cells Therapy treatment. It plans to enroll 40 participants.
- What's involved
- Participants will receive Autologous Adipose Cells therapy treatment, and their safety and effectiveness will be monitored up to 25 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from their first post-treatment visit up to 25 weeks after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Autologous Adipose Cells Therapy
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Dr. Abdollah M. Malekzadeh, MD, MD · PRINCIPAL_INVESTIGATOR · The Centre for Cosmetic Surgery & Medicine
- Dr. Arun Kumar, PhD · STUDY_DIRECTOR · CERM INC.
Who to contact
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What this trial measures
- Outcome Comparison SurveyThe 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 SurveyFrom 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 AssessmentFrom 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 FormThe 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 ReportFrom 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