Autologous Adipose Cells Therapy

May 30, 2025 updated by: CERM INC.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Autologous fat grafting (AFG) and injection of dermal fillers are the most prevailing aesthetic procedures in the cosmetic field for skin rejuvenation and hair restoration. High degree of biocompatibility and biodegradability of dermal fillers contribute significantly to their effectiveness in skin rejuvenation and hair restoration; however, the results are typically not enduring. On the other hand, autologous fat grafting is increasingly recognized for its applications not only in skin rejuvenation, but also breast augmentation and the treatment of arthritis. Fat fillers are fully biocompatible to the recipient, due to the use of autologous cell, the effects generally persist longer than those achieved with dermal fillers. Nonetheless, unprocessed lipoaspirate collected through liposuction procedure has a heterogeneous composition, which potentially leads to uneven distribution of adipose tissu resulting in formation of lumps or nodules at the recipient's site. Volume retention following autologous fat grafting is not solely affected by the resorption rate of adipose cells, but also impacted by re-uptake rate of other components of lipoaspirate. Autologous Adipose Cell Therapy seeks to enhance the current autologous fat grafting by isolating early-stage adipose cells from lipoaspirate and optimizing the number of adipocytes cells within the fat filler through cell property of differentiation. The purpose of this study is to assess the safety, feasibility, and efficacy of Autologous Adipose Cell Therapy for skin rejuvenation and hair improvement in human subjects. The eligibility of participants who are interested in participating in this study will be determined based on the inclusion and exclusion criteria listed in the study protocol. The in-charge plastic surgeon will monitor and evaluate the treatment outcomes in participants over a six-months period after the administration of Autologous Adipose Cell Therapy.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Outpatients who are experiencing hair loss or hair thinning
  3. Provision of signed and dated informed consent form
  4. Clearly stated willingness to comply with all the procedures of the study and availability of the study
  5. Female and Male aged between 21 to 80 years old 6 Medical clearance by family doctor

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Known allergic reaction to components of cell culture media
  3. Chronic disease , e.g. cardiovascular disease, diabetes, chronic kidney disease, seizures
  4. Chronic infections, e.g. skin fungi infection, psoriasis
  5. Chronic wound healing
  6. Currently taking hormone therapy
  7. History of cancers and active cancers
  8. Viral infection, e.g. HIV, hepatitis B, influenza, coronaviruses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous Adipose Cells Therapy
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome Comparison Survey
Time Frame: 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%)
The end of the study (Week 20 to 25)
Participant Satisfaction Survey
Time Frame: 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"
From first post-treatment follow-up visit to the last follow-up visit at week 16 to week 25
Imaging Assessment
Time Frame: 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.
From first pre-treatment visit to the last follow-up visit at week 16 to week 25
Case Report Form
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.
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.
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.
Visit Evaluation Report
Time Frame: 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
From first post-treatment follow-up visit to the last follow-up visit at week 16 to week 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CERM INC.

Investigators

  • Principal Investigator: Dr. Abdollah M. Malekzadeh, MD, MD, The Centre for Cosmetic Surgery & Medicine
  • Study Director: Dr. Arun Kumar, PhD, CERM INC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 30, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERM 002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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