Recruiting
Phase 1
Phase 2

Autologous Adipose Cells

Sponsor:

CERM INC.

Code:

NCT06869252

Conditions

Hair Loss/Baldness

Wrinkle Appearance

Volume

Fine Lines

Skin Elasticity

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Autologous Adipose Cells Therapy

Study Details

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

Study ID

NCT06869252

Start date

Aug 1, 2025

Status verified date

May, 2025

Completion date

Feb 1, 2026

Anticipated

Primary completion date

Nov 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not 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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Autologous Adipose Cells Therapy

Interventions

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.

Primary outcome measure

  • Outcome Comparison Survey [ Time Frame: 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 ]
  • Imaging Assessment [ Time Frame: 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. ]
  • Visit Evaluation Report [ Time Frame: From first post-treatment follow-up visit to the last follow-up visit at week 16 to week 25 ]

Central Contacts and Locations

Locations

The Centre for Cosmetic Surgery & Medicine, Newark

Recruiting

Lewes, Delaware, United States, 19958

Contacts

The Centre for Cosmetic Surgery & Medicine

Recruiting

Newark, Delaware, United States, 19713

Contacts

More Information

Sponsor

CERM INC.

Last update posted

May 31, 2025

Last verified

May, 2025

Keywords

  • Adipose Cells
  • Adipocytes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CERM INC. on 2025-05-31.