Evaluation of the Efficacy and Tolerability of Autologous Adipose Tissue Derived Stem Cells on Facial Rejuvenation
Phase: NA
Conditions: Skin Rejuvenation
Sponsor: Alexandria University

 
 
 
 
Title of the study: Evaluation of the Efficacy and Tolerability of Autologous 
Adipose Tissue Derived Stem Cells on Facial Rejuvenation 
Date of the document: January 1, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Investigators and study group: 
Osama Hussein Roshdy MD, PhD 
Professor of Dermatology, Dermatology Department, Faculty of Medicine, 
Alexandria University, Egypt. 
Wafaa Ibrahim Abdullah MD, PhD 
Professor of Dermatology, Dermatology Department, Faculty of Medicine, 
Alexandria University, Egypt. 
Carmen Ibrahim Farid Mohammed Amin MD, PhD 
Professor of Dermatology, Dermatology Department, Faculty of Medicine, 
Alexandria University, Egypt. 
Radwa Ali Mehana, MD, PhD 
Assistant Professor of Physiology, Physiology Department, Faculty of 
Medicine, Alexandria University, Egypt. 
Nader Hussein Lotfy Bayoumi. MD, PhD, FRCS (Glasgow) 
Professor of Ophthalmology, Ophthalmology Department, Faculty of 
Medicine, Alexandria University, Egypt. 
Aliaa Ismail, MD, PhD 
Assistant Lecturer of Dermatology, Dermatology Department, Faculty of 
Medicine, Alexandria University, Egypt. 

INTRODUCTION 
 
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.(1,2)  
                 
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.(3) 
             
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.(4) 
            
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 process.(5) 
           
There are an increasing number of treatment modalities to improve the appearance 
of aging skin including dermal fillers, injectable botulinum toxin, laser, chemical 
peeling and a diverse of topical agents including topical retinoid.(6) 
 
Autologous fat grafting or lipo injection containing stromal vascular fraction 
(SVF) acts like ideal soft tissue filler for facial filling and rejuvenation.(4) It leads 
to progressive improvement of the skin texture, elasticity, and color over a few 

months, therefore adipose tissue seems to be not only a simple filler but also a 
dynamic filler with two types of different and supplementary effects, the 
volumetric effect and the regenerative effect.(7) 
             
Recently, 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).(8) 
            
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.(9)       
             
Cell assisted lipotransfer (CAL) is a technique that combines aspirated fat with 
concentrated ADSCs in the stromal vascular fraction (SVF) of the lipoaspirate. 
This technique could  enhance the survival rate of the transplanted fat and leads to 
better cosmetic improvement.(8) 
 
 
 
 
 
 
 

AIM OF THE WORK 
 
The aim of this work is to evaluate the efficacy and tolerability of autologous 
adipose tissue derived stem cells in facial rejuvenation  

PATIENTS 
 
The current study will be carried out on thirty healthy female participants recruited 
from the Outpatient Clinic of the Dermatology Department of Alexandria Main 
university hospital.  
 
Inclusion criteria: 
1. Clinically diagnosed facial skin aging.  
2. Glogau photoaging score II and III. 
3. Body mass index ≥20 with adequate abdominal or other subcutaneous 
adipose tissue accessible for lipoaspiration. 
 
Exclusion criteria: 
1. History of keloid formation. 
2. Any coincidental chronic illness (e.g. metabolic, autoimmune or 
endocrinal) or malignancy. 
3. Any bleeding or coagulation disorder or recent use of anticoagulant 
therapy.  
4. Active infection.  
5. History of any previous aesthetic procedure on the face within the past 
6 months. 
6. History of intake of anti-aging systemic or topical medications within 
the previous 3 months. 
 
An informed consent for both participations in the study and photography will be 
taken from all participants prior to the onset of the study after full explanation of 
the procedure and its follow up steps. Patients will have to sign to committing to 
the study protocol, using sun protection, and abstaining from using or doing any 
anti-ageing steps during the study period.  

 
METHODS 
 
All participants will be subjected to: 
1. Full history taking including personal, family, medical and drug history.  
2. History of any previous aesthetic procedures on the face. 
3. BMI calculation.(10) 
4. Baseline assessment of facial skin ageing will be done using the following 
techniques:  
 Base line standardized digital photography of the face before the 
procedure and in each follow up visit. 
 Assessment of degree of improvement using Global Aesthetic 
improvement scale on serial photography. 
 Assessment of trans-epidermal water loss (TEWL) and skin hydration 
using noninvasive probe (Dermal measurement system EDS12, UK) on 
both temple regions of the head.(13) 
 Measurement of epidermal, dermal and hypodermal thickness using 
UBM (Ultrasound Bio microscopy) on both temple regions of the 
head.(14) 
 
Lipoaspiration for preparation of ADSC will be done according to the 
following technique: (7) 
Under local anesthesia using strict aseptic technique, a small incision will be done 
in the lateral aspect of the thigh or lower abdomen, through which the infiltration 
cannula will be introduced to inject the local anesthetic solution using the wet 
technique. This will be followed 15 minutes later by lipo-aspiration of (50 ml fat) 
using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe.  
 Autologous adipose tissue derived stem cells (At-ADSCs) will be 
separated from the lipo-aspirate using enzymatic digestion and 
differential centrifugation in the Center of Excellence for Research in 

Regenerative Medicine and its Application (CERRMA), Alexandria 
Faculty of Medicine. 
 Viability of collected cells will be checked using trypan blue stain.(15) 
Characterization of the isolated ADSCs population will be performed by 
flow cytometry to check for specific cell surface CD antigens (CD 90 and 
CD 34) in three independent cases in triplet.(7) 
 
 Aspiration of 50 ml of fat followed by preparation of At-ADSCs. 
 One half of the face will be chosen randomly to receive intradermal injection 
of adipose tissue derived stem cell solution, while the other half will be 
subjected to intradermal injection of equal volume of saline as a control. 
 
 
 
Follow up and evaluation: 
 Early assessment of trans-epidermal water loss (TEWL) and skin hydration 
will be carried out  a week after the procedure. 
 All participants will be followed up six months after the procedure. Follow 
up will entail using the same base line assessment steps to detect the effects 
of treatment. Side effects reported by the participants will be recorded. 
 Assessment of the participants and the photos will be carried out by a 
blinded investigator to the half treated and the before versus after photos. 
 A visual analog scale, (16) will be used to assess participants’ satisfaction by 
the treatment 
 
 
 
 
 

ETHICS OF RESEARCH 
 
Research on human or human products: 
 
Prospective study: informed consent will be taken from patients. In 
case of incompetent patients the informed consent will be taken from the 
guardians. 
 
Retrospective study: confidentiality of records will be considered. 
 
DNA/genomic material: informed consent for DNA / genomic test 
and for research will be taken from patients. No further test will be carried 
out except with further approval of committee and patients. If the samples 
will travel outside Egypt the researcher will be responsible for transportation 
and security approval. 
 
All drugs used in the research are approved by the Egyptian Ministry 
of Health. 
 
 
Research on animal: 
 
The animal species are appropriate for the test. 
 
After test, if animal will suffer, it will be euthanized and properly 
disposed. 
 
After operation, it will have a proper postoperative care. 
 
 

RESULTS 
 
The results obtained will be tabulated, statistically analyzed and findings will be 
illustrated using tables and figures. 

DISCUSSION 
 
The results obtained will be discussed in view of achievement of the aim of the 
work and compared with other findings in literature. 

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