Autologous Adipose Cells Therapy

NCT06869252 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CERM 002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hair Loss/Baldness; Wrinkle Appearance; Volume; Fine Lines; Skin Elasticity; Hair Thinning; Skin Pigmentation; Skin Texture

Keywords

Adipose Cells; Adipocytes

Outcome Measures

Primary Outcomes (5)

• 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%)

  The end of the study (Week 20 to 25)

• 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"

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

• 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.

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

• 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.

  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

  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

Study Arms (1)

Autologous Adipose Cells Therapy

EXPERIMENTAL

Biological: Autologous Adipose Cells Therapy

Interventions

Autologous Adipose Cells Therapy BIOLOGICAL

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.

Autologous Adipose Cells Therapy

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Female and Male aged between 21 to 80 years old 6 Medical clearance by family doctor

You may not qualify if:

• 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
• Chronic wound healing
• Currently taking hormone therapy
• History of cancers and active cancers
• Viral infection, e.g. HIV, hepatitis B, influenza, coronaviruses.

Sponsors & Collaborators

• CERM INC.: lead

Study Sites (2)

The Centre for Cosmetic Surgery & Medicine, Newark

Lewes, Delaware, 19958, United States

RECRUITING

The Centre for Cosmetic Surgery & Medicine

Newark, Delaware, 19713, United States

RECRUITING

Related Publications (3)

• Bellini E, Grieco MP, Raposio E. The science behind autologous fat grafting. Ann Med Surg (Lond). 2017 Nov 10;24:65-73. doi: 10.1016/j.amsu.2017.11.001. eCollection 2017 Dec.

  PMID: 29188051 BACKGROUND

• Sutcliffe H, Rawlinson PS, Thakker B, Neary R, Mallick N. Factitious proteinuria: diagnosis and protein identification by use of isoelectric focusing. Clin Chem. 1988 Aug;34(8):1653-5.

  PMID: 3402073 BACKGROUND

• An Y, Wang G, Li X, Zhen Y, Zhao J, Li D. Rhinoplasty with Simultaneous Autologous Full-Face Fat Transfer for Asian Facial Contouring Balance: A Retrospective Study. Aesthetic Plast Surg. 2023 Apr;47(2):746-756. doi: 10.1007/s00266-022-03064-6. Epub 2022 Aug 30.

  PMID: 36042025 BACKGROUND

MeSH Terms

Conditions

Alopecia; Pigmentation Disorders

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Dr. Abdollah M. Malekzadeh, MD, MD

  The Centre for Cosmetic Surgery & Medicine

  PRINCIPAL INVESTIGATOR

• Dr. Arun Kumar, PhD

  CERM INC.

  STUDY DIRECTOR

Central Study Contacts

Ankeet Dixit

CONTACT

813-992-2521; ankeetdixit@cermbio.com

Wing Nam Fung

CONTACT

207-671-9370; wingnam@cermbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 11, 2025
• Study Start: August 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

US (2)