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

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ClinicalTrials.gov Identifier: NCT03928444
Recruitment Status : Active, not recruiting
First Posted : April 26, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Aliaa Ismail Ali Ismail, Alexandria University

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

Condition or disease Intervention/treatment Phase
Skin Rejuvenation Procedure: intradermal injection of adipose derived stem cells to one side of the face Procedure: intradermal injection of saline to one side of the face Not Applicable

Detailed Description:
Skin aging is a complex biological process that can be categorized into either extrinsic or intrinsic aging. Intrinsic aging is an inherent degenerative process caused by decreased proliferative capacity leading to cellular senescence. Extrinsic aging is caused by factors such as UV radiations, smoking and alcohol consumption.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.Aging skin undergoes thinning of the epidermis that is caused by reduction of vascularity and hydration. On average, the thickness of the epidermis is reduced by about 6.4% during each decade of life.Skin aging effects can be assessed based on the skin appearance (texture and roughness, fine lines and wrinkles), structure, elasticity, hydration and barrier function. Many new non-invasive or minimally invasive bioengineering advances in recent years have enabled the quantitative analysis of skin properties during the aging processRecently, adult stem cells such as mesenchymal stem cells (MSCs) have been used in variable dermatologic conditions due to its regenerative properties such as wound healing, rejuvenation, acne scar and hair fall treatment. Different types of MSCs could be derived from different tissues as for example; bone marrow stem cells (BMSCs), adipose tissue-derived stem cells (ADSCs), and skin-derived stem cells (SDSCs)Adipose tissue derived stem cells are currently favorable compared to other types of adult stem cells as the procedure is easy, safe with minimal donor site morbidity. The process of obtaining a considerable amount of adipose tissues sufficient to use in skin regeneration is highly appealing due to its relative availability and accessibility. They secrete variable growth factors that affect surrounding environment as vascular endothelial growth factor (VEGF), platelet derived growth factor (PDGF), insulin like growth factors (IGF) and others

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: split face
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Tolerability of Autologous Adipose Tissue Derived Stem Cells on Facial Rejuvenation
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: stem cells
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

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.

Placebo Comparator: control
one side of face treated with intradermal saline
Procedure: intradermal injection of saline to one side of the face
intradermal injection of saline to one side of the face




Primary Outcome Measures :
  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. [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 6 months ]
    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

  2. Assessment of skin hydration in units using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head [ Time Frame: 6 months ]
    Assessment of hydration in units using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head

  3. Measurement of epidermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head [ Time Frame: 6 months ]
    Measurement of epidermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head

  4. Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head [ Time Frame: 6 months ]
    Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head

  5. A visual analog scale, will be used to assess participants' satisfaction by the treatment and side effects [ Time Frame: 6 months ]
    A visual analog scale, will be used to assess participants' satisfaction by the treatment and side effects



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928444


Locations
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Egypt
Aliaa Ismail
Alexandria, Egypt, 21521
Sponsors and Collaborators
Alexandria University
Investigators
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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, 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 Documents (Full-Text)

Documents provided by Aliaa Ismail Ali Ismail, Alexandria University:
Study Protocol  [PDF] January 1, 2019


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Responsible Party: Aliaa Ismail Ali Ismail, principle investigator, Alexandria University
ClinicalTrials.gov Identifier: NCT03928444     History of Changes
Other Study ID Numbers: AlexandriaUdermatology
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aliaa Ismail Ali Ismail, Alexandria University:
Adipose tissue derived stem cells
Facial rejuvenation