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

Skin Rejuvenation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03965936
• Other study ID #: alexderma 2
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 16, 2019

Study information

• Verified date: July 2019
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 16, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lipofilling
• Skin Rejuvenation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Aliaa Ismail	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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