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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stem cells | Experimental | one side of the face to be treated with intradermal stem cells |
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| control | Placebo Comparator | one side of face treated with intradermal saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intradermal injection of adipose derived stem cells to one side of the face | Procedure | 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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Ibrahim Farid Mohammed Amin, MD | Assistant Professor of Dermatology, Faculty of Medicine, Alexandria University | Study Director |
| Ossama Hussein Roshdy, MD | Professor of Dermatology, Faculty of Medicine, Alexandria University | Study Director |
| Wafaa Ibrahim Abdullah, MD | Professor of Dermatology, Faculty of Medicine, Alexandria University | Study Director |
| Radwa Ali Mehanna, PhD | Assistant Professor of Physiology, Faculty of Medicine, Alexandria University | Study Director |
| Nader Hussein Lotfy Bayoumi., MD, FRCS | Professor of ophthalmology , Faculty of Medicine, Alexandria University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aliaa Ismail | Alexandria | 21521 | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2019 | Apr 23, 2019 |
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split face
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| intradermal injection of saline to one side of the face | Procedure | intradermal injection of saline to one side of the face |
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| 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 |
| 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 | 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 | 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 | 6 months |
| Prot_000.pdf |