An interventional study of intradermal injection of adipose derived stem cells to one side of the face and intradermal injection of saline to one side of the face in Skin Rejuvenation, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to female participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
This study is to evaluate the efficacy and tolerability of autologous adipose tissue derived stem cells in facial rejuvenation.
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
Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
one side of the face to be treated with intradermal stem cells
Procedure: intradermal injection of adipose derived stem cells to one side of the face
one side of face treated with intradermal saline
Procedure: intradermal injection of saline to one side of the face
Lipoaspiration for preparation of ADSC will be done according to the following technique: 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. Characterization of the isolated ADSCs population will be performed by flow cytometry.
intradermal injection of saline to one side of the face
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.
serial photography for assessment of 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.
Time frame: 6 months
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
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
Time frame: 6 months
Assessment of skin hydration in units using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head
Assessment of hydration in units using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head
Time frame: 6 months
Measurement of epidermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Measurement of epidermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Time frame: 6 months
Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Time frame: 6 months
A visual analog scale, will be used to assess participants' satisfaction by the treatment and side effects
A visual analog scale, will be used to assess participants' satisfaction by the treatment and side effects
Time frame: 6 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Alexandria University