Clinical trial NCT03928444: Evaluation of the Efficacy and Tolerability of Autologous Adipose Tissue Derived Stem Cells on Facial Rejuvenation
Official title: Evaluation of the Efficacy and Tolerability of Autologous Adipose Tissue Derived Stem Cells on Facial Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Rejuvenation
Keywords: Adipose tissue derived stem cells
Facial rejuvenation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 15
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split face
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and tolerability of autologous adipose tissue derived stem cells in facial rejuvenation.

Detailed description: Skin aging is a complex biological process that can be categorized into either extrinsic or intrinsic aging. Intrinsic aging is an inherent degenerative process caused by decreased proliferative capacity leading to cellular senescence. Extrinsic aging is caused by factors such as UV radiations, smoking and alcohol consumption.The physiological changes associated with aging of the skin are manifested in xerosis, dramatic loss of skin elasticity due to damage to collagen and elastin fibers; as well as barrier function, modification of rhytides and deficiencies in the regenerative property of the skin. All of which ultimately result in thinning of the skin, malar fat atrophy and pigmentary changes.Aging skin undergoes thinning of the epidermis that is caused by reduction of vascularity and hydration. On average, the thickness of the epidermis is reduced by about 6.4% during each decade of life.Skin aging effects can be assessed based on the skin appearance (texture and roughness, fine lines and wrinkles), structure, elasticity, hydration and barrier function. Many new non-invasive or minimally invasive bioengineering advances in recent years have enabled the quantitative analysis of skin properties during the aging processRecently, adult stem cells such as mesenchymal stem cells (MSCs) have been used in variable dermatologic conditions due to its regenerative properties such as wound healing, rejuvenation, acne scar and hair fall treatment. Different types of MSCs could be derived from different tissues as for example; bone marrow stem cells (BMSCs), adipose tissue-derived stem cells (ADSCs), and skin-derived stem cells (SDSCs)Adipose tissue derived stem cells are currently favorable compared to other types of adult stem cells as the procedure is easy, safe with minimal donor site morbidity. The process of obtaining a considerable amount of adipose tissues sufficient to use in skin regeneration is highly appealing due to its relative availability and accessibility. They secrete variable growth factors that affect surrounding environment as vascular endothelial growth factor (VEGF), platelet derived growth factor (PDGF), insulin like growth factors (IGF) and others

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed facial skin aging.
* Glogau photoaging score II and III.
* Body mass index ≥20 with adequate abdominal or other subcutaneous adipose tissue accessible for lipoaspiration.

Exclusion Criteria:

* History of keloid formation.
* Any coincidental chronic illness (e.g. metabolic, autoimmune or endocrinal) or malignancy.
* Any bleeding or coagulation disorder or recent use of anticoagulant therapy.
* Active infection.
* History of any previous aesthetic procedure on the face within the past 6 months.
* History of intake of anti-aging systemic or topical medications within the previous 3 months.

Primary outcomes:
measure: Assessment of the degree of aesthetic improvement using the global aesthetic improvement scale GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of trans-epidermal water loss (TEWL) in gm /h-m2 using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head
timeFrame: 6 months
measure: Assessment of skin hydration in units using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head
timeFrame: 6 months
measure: Measurement of epidermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
timeFrame: 6 months
measure: Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
timeFrame: 6 months
measure: A visual analog scale, will be used to assess participants' satisfaction by the treatment and side effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Aliaa Ismail
Study officials:
affiliation: Assistant Professor of Dermatology, Faculty of Medicine, Alexandria University
name: Carmen Ibrahim Farid Mohammed Amin, MD
role: STUDY_DIRECTOR
affiliation: Professor of Dermatology, Faculty of Medicine, Alexandria University
name: Ossama Hussein Roshdy, MD
role: STUDY_DIRECTOR
affiliation: Professor of Dermatology, Faculty of Medicine, Alexandria University
name: Wafaa Ibrahim Abdullah, MD
role: STUDY_DIRECTOR
affiliation: Assistant Professor of Physiology, Faculty of Medicine, Alexandria University
name: Radwa Ali Mehanna, PhD
role: STUDY_DIRECTOR
affiliation: Professor of ophthalmology , Faculty of Medicine, Alexandria University
name: Nader Hussein Lotfy Bayoumi., MD, FRCS
role: STUDY_DIRECTOR
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