Autologous Adipose Cells Therapy

CERM INC.

Status and phase: Enrolling; Phase 2; Phase 1

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

Treatments: Biological: Autologous Adipose Cells Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06869252

CERM 002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Autologous Adipose Cells Therapy

Experimental group

Treatment:

Biological: Autologous Adipose Cells Therapy