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

A

Alexandria University

Status

Completed

Conditions

Skin Rejuvenation

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03928444
AlexandriaUdermatology

Details and patient eligibility

About

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

Full 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

Enrollment

15 patients

Sex

Female

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 2 patient groups, including a placebo group

stem cells
Experimental group
Description:
one side of the face to be treated with intradermal stem cells
Treatment:
Procedure: intradermal injection of adipose derived stem cells to one side of the face
control
Placebo Comparator group
Description:
one side of face treated with intradermal saline
Treatment:
Procedure: intradermal injection of saline to one side of the face

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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