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

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ClinicalTrials.gov Identifier: NCT03965936
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Aliaa Ismail Ali Ismail, Alexandria University

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

Condition or disease Intervention/treatment Phase
Skin Rejuvenation Lipofilling Procedure: lipofilling Procedure: lipofilling enriched with adipose tissue derived stem cells Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: split face
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Adipose Derived Stem Cells on Survival of Fat as Filler
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : July 16, 2019
Actual Study Completion Date : July 16, 2019

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.





Primary Outcome Measures :
  1. Assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness [ Time Frame: 3 months, 6 months ]
    serial photography for assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness


Secondary Outcome Measures :
  1. Measurement of hypodermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head [ Time Frame: 3 months, 6 months ]
    Measurement of hypodermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head

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



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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

  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

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): NCT03965936


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, 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 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: NCT03965936     History of Changes
Other Study ID Numbers: alexderma 2
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 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
lipofilling