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this research is to study the effect of Adipose Derived Stem Cells on Survival of Fat as Filler
Skin aging is a complex biological process.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. Autologous fat grafting or lipo injection containing stromal vascular fraction (SVF) acts like ideal soft tissue filler for facial filling and rejuvenation. 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.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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lipofilling | Placebo Comparator | subcutaneous injection of lipoaspiate (microfat) in one temporal region |
|
| lipofilling enriched with adipose tissue derived stem cells | Active Comparator | subcutaneous injection of lipoaspiate enriched with adipose tissue derived stem cells in one temporal region |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lipofilling | Procedure | 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 75 ml fat ) using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe. 50 ml is used for preparation of microfat. then with blunt cannula,subcutaneous injection of the required volume of microfat is placed into temporal region. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness | serial photography for assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness | 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of hypodermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head | Measurement of hypodermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head | 3 months, 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 |
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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, University of Alexandria. | Study Director |
| Wafaa Ibrahim Abdullah, MD | Professor of Dermatology, Faculty of Medicine, University of Alexandria. | 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, University of Alexandria. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aliaa Ismail | Alexandria | 21521 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35125305 | Derived | Roshdy OH, Abdallah WI, Farid CI, Mehanna RA, Bayoumi NH, Ismail AI. Stromal vascular fraction improves the durability of autologous fat temple augmentation-A split-face randomized study using ultrasound biomicroscopy. J Plast Reconstr Aesthet Surg. 2022 Jun;75(6):1870-1877. doi: 10.1016/j.bjps.2021.12.005. Epub 2022 Jan 15. |
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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 | May 24, 2019 | Prot_000.pdf |
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split face
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|
| lipofilling enriched with adipose tissue derived stem cells | Procedure | 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 75 ml fat using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe. 50 ml is used for preparation of microfat. 25 ml is used for preparation of autologous adipose tissue derived stem cells (At-ADSCs) using enzymatic digestion and differential centrifugation in the Center of Excellence for Research in Regenerative Medicine and its Application (CERRMA), Alexandria Faculty of Medicine. Subcutaneous injection of the required volume of microfat combined with stromal vascular fraction containing adipose tissue derived stem cells, is placed into temporal region. |
|
Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head |
| 3 months, 6 months |