Clinical trial NCT06869252: Autologous Adipose Cells Therapy
Official title: Autologous Adipose Cells Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Hair Loss/Baldness
Wrinkle Appearance
Volume
Fine Lines
Skin Elasticity
Hair Thinning
Skin Pigmentation
Skin Texture
Keywords: Adipose Cells
Adipocytes
Lead sponsor: CERM INC.
Sponsor class: INDUSTRY
First posted: 2025-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Outcome Comparison Survey
timeFrame: The end of the study (Week 20 to 25)
measure: Participant Satisfaction Survey
timeFrame: From first post-treatment follow-up visit to the last follow-up visit at week 16 to week 25
measure: Imaging Assessment
timeFrame: From first pre-treatment visit to the last follow-up visit at week 16 to week 25
measure: Case Report Form
timeFrame: 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.
measure: Visit Evaluation Report
timeFrame: From first post-treatment follow-up visit to the last follow-up visit at week 16 to week 25
Secondary outcomes:
Other outcomes:
Locations:
city: Lewes
country: United States
facility: The Centre for Cosmetic Surgery & Medicine, Newark
state: Delaware
city: Newark
country: United States
facility: The Centre for Cosmetic Surgery & Medicine
state: Delaware
Study officials:
affiliation: The Centre for Cosmetic Surgery & Medicine
name: Dr. Abdollah M. Malekzadeh, MD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CERM INC.
name: Dr. Arun Kumar, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.