Clinical trial NCT03965936: Effect of Adipose Derived Stem Cells on Survival of Fat as Filler
Official title: Effect of Adipose Derived Stem Cells on Survival of Fat as Filler
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Rejuvenation
Lipofilling
Keywords: adipose tissue derived stem cells
lipofilling
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 15
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split face
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria

1. Clinically diagnosed facial skin aging.
2. Glogau photoaging score II and III.
3. Body mass index ≥20 with adequate abdominal or other subcutaneous adipose tissue accessible for lipoaspiration.

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

Primary outcomes:
measure: Assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness
timeFrame: 3 months, 6 months
Secondary outcomes:
measure: Measurement of hypodermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
timeFrame: 3 months, 6 months
measure: 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
timeFrame: 3 months, 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Aliaa Ismail
Study officials:
affiliation: Assistant Professor of Dermatology, Faculty of Medicine, Alexandria University.
name: Carmen Ibrahim Farid Mohammed Amin, MD
role: STUDY_DIRECTOR
affiliation: Professor of Dermatology, Faculty of Medicine, University of Alexandria.
name: Ossama Hussein Roshdy, MD
role: STUDY_DIRECTOR
affiliation: Professor of Dermatology, Faculty of Medicine, University of Alexandria.
name: Wafaa Ibrahim Abdullah, MD
role: STUDY_DIRECTOR
affiliation: Assistant Professor of Physiology, Faculty of Medicine, Alexandria University
name: Radwa Ali Mehanna, PhD
role: STUDY_DIRECTOR
affiliation: Professor of ophthalmology , Faculty of Medicine, University of Alexandria.
name: Nader Hussein Lotfy Bayoumi., MD, FRCS
role: STUDY_DIRECTOR
References:
citation: 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.