Autologous Adipose Cells Therapy

NCT ID: NCT06869252

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Autologous Adipose Cells Therapy

Group Type EXPERIMENTAL

Autologous Adipose Cells Therapy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CERM INC.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr. Abdollah M. Malekzadeh, MD, MD

Role: PRINCIPAL_INVESTIGATOR

The Centre for Cosmetic Surgery & Medicine

Dr. Arun Kumar, PhD

Role: STUDY_DIRECTOR

CERM INC.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Centre for Cosmetic Surgery & Medicine, Newark

Lewes, Delaware, United States

Site Status RECRUITING

The Centre for Cosmetic Surgery & Medicine

Newark, Delaware, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ankeet Dixit

Role: CONTACT

813-992-2521

Wing Nam Fung

Role: CONTACT

207-671-9370

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dr. Abdollah M. Malekzadeh, MD

Role: primary

302-645-7672

Role: backup

Dr. Abdollah M. Malekzadeh, MD

Role: primary

302-994-8492

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29188051 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3402073 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36042025 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CERM 002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Secretome Treatment for Facial Rejuvenation
NCT07227883 RECRUITING EARLY_PHASE1