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

Not Applicable

Completed

• Conditions: Lipofilling; Skin Rejuvenation
• Interventions: Procedure: lipofilling; Procedure: lipofilling enriched with adipose tissue derived stem cells

• Registration Number: NCT03965936
• Lead Sponsor: Alexandria University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-29
• Status Verified: 2019-07
• Primary Completion: 2019-07-16
• Study Completion: 2019-07-16
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lipofilling	lipofilling	subcutaneous injection of lipoaspiate (microfat) in one temporal region
lipofilling enriched with adipose tissue derived stem cells	lipofilling enriched with adipose tissue derived stem cells	subcutaneous injection of lipoaspiate enriched with adipose tissue derived stem cells in one temporal region

Primary Outcome Measures

Name	Time	Method
Assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness	3 months, 6 months	serial photography for assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness

Secondary Outcome Measures

Name	Time	Method
Measurement of hypodermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head	3 months, 6 months	Measurement of hypodermal 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	Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head

Trial Locations

Locations (1)

Aliaa Ismail; 🇪🇬 Alexandria, Egypt