Effect of Adipose Derived Stem Cells on Survival of Fat as Filler

Study Overview
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Brief Summary
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this research is to study the effect of Adipose Derived Stem Cells on Survival of Fat as Filler

Detailed Description
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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

Official Title
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Effect of Adipose Derived Stem Cells on Survival of Fat as Filler

Conditions
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Skin Rejuvenation, Lipofilling

Intervention / Treatment
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* Procedure: lipofilling
* Procedure: lipofilling enriched with adipose tissue derived stem cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: split face
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: lipofilling<br>subcutaneous injection of lipoaspiate (microfat) in one temporal region | Procedure: lipofilling<br>* 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.<br>|
| Active Comparator: lipofilling enriched with adipose tissue derived stem cells<br>subcutaneous injection of lipoaspiate enriched with adipose tissue derived stem cells in one temporal region | Procedure: lipofilling enriched with adipose tissue derived stem cells<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head | 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adipose tissue derived stem cells, lipofilling