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

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

Study Overview

• Status: Completed
• Conditions: Lipofilling; Skin Rejuvenation
• Intervention / Treatment: Procedure: lipofilling; Procedure: lipofilling enriched with adipose tissue derived stem cells

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21521
    • Aliaa Ismail

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Director: Radwa Ali Mehanna, PhD, Assistant Professor of Physiology, Faculty of Medicine, Alexandria University; Study Director: 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: Nader Hussein Lotfy Bayoumi., MD, FRCS, Professor of ophthalmology , Faculty of Medicine, University of Alexandria.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): July 16, 2019
• Study Completion (Actual): July 16, 2019

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: lipofilling; adipose tissue derived stem cells
• Other Study ID Numbers: alexderma 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No