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

NCT03965936 | Completed DMC

• 1 other identifier: alexderma 2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Rejuvenation; Lipofilling

Keywords

adipose tissue derived stem cells; lipofilling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  3 months, 6 months

Study Arms (2)

lipofilling

PLACEBO COMPARATOR

subcutaneous injection of lipoaspiate (microfat) in one temporal region

Procedure: lipofilling

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

Procedure: lipofilling enriched with adipose tissue derived stem cells

Interventions

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.

lipofilling

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.

lipofilling enriched with adipose tissue derived stem cells

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Aliaa Ismail

Alexandria, 21521, Egypt

Location

Related Publications (1)

• 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.

  PMID: 35125305 DERIVED

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: split face

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: January 1, 2019
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)