Evaluation of the Efficacy and Tolerability of Autologous Adipose Tissue Derived Stem Cells on Facial Rejuvenation

NCT03928444 | Completed DMC

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

Brief Summary

This study is to evaluate the efficacy and tolerability of autologous adipose tissue derived stem cells in facial rejuvenation.

Conditions

Skin Rejuvenation

Keywords

Adipose tissue derived stem cells; Facial rejuvenation

Outcome Measures

Primary Outcomes (1)

• Assessment of the degree of aesthetic improvement using the global aesthetic improvement scale GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.

  serial photography for assessment of degree of aesthetic improvement using the global aesthetic improvement scale GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.

  6 months

Secondary Outcomes (5)

• Assessment of trans-epidermal water loss (TEWL) in gm /h-m2 using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head

  6 months

• Assessment of skin hydration in units using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head

  6 months

• Measurement of epidermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head

  6 months

• Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head

  6 months

• A visual analog scale, will be used to assess participants' satisfaction by the treatment and side effects

  6 months

Study Arms (2)

stem cells

EXPERIMENTAL

one side of the face to be treated with intradermal stem cells

Procedure: intradermal injection of adipose derived stem cells to one side of the face

control

PLACEBO COMPARATOR

one side of face treated with intradermal saline

Procedure: intradermal injection of saline to one side of the face

Interventions

intradermal injection of adipose derived stem cells to one side of the face PROCEDURE

Lipoaspiration for preparation of ADSC will be done according to the following technique: 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 (50 ml fat ) using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe. * Autologous adipose tissue derived stem cells (At-ADSCs) will be separated from the lipo-aspirate using enzymatic digestion and differential centrifugation in the Center of Excellence for Research in Regenerative Medicine and its Application (CERRMA), Alexandria Faculty of Medicine. * Viability of collected cells will be checked using trypan blue stain. Characterization of the isolated ADSCs population will be performed by flow cytometry.

stem cells

intradermal injection of saline to one side of the face PROCEDURE

intradermal injection of saline to one side of the face

control

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

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, Alexandria University

  STUDY DIRECTOR

• Wafaa Ibrahim Abdullah, MD

  Professor of Dermatology, Faculty of Medicine, Alexandria University

  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, Alexandria University

  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: April 21, 2019
• First Posted: April 26, 2019
• Study Start: January 1, 2019
• Primary Completion: August 6, 2019
• Study Completion: August 6, 2019
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)