Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

Autologous Very Small Embryonic-like Stem Cells(VSELs) for Facial Skin Antiaging

The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to facial skin antiaging.

Study Overview

• Status: Withdrawn
• Conditions: Stem Cell Transplant Complications; Skin Inflammation
• Intervention / Treatment: Biological: Very small embryonic-like stem cell

Detailed Description

VSELs come from the patient's peripheral blood, and will be injected in left preauricular area, followed by skin pathology to compare the improvement of skin aging. Two 0.5 × 1 cm fragments of skin and subcutaneous tissue was removed from bilateral preauricular areas for morphologic analysis by optical and electron microscopy. Histologic analysis of skin biopsy specimens was performed by hematoxylin and eosin, picrosirius red (for visualization of collagen), and orcein (for visualization of elastic fibers) staining.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Biological treatment center in Fuda cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers with anti-aging willingness

Exclusion Criteria:

• Metabolic and systemic diseases such as diabetes and atherosclerosis
• Facial skin diseases such as herpes, eczema, skin rash, systemic lupus erythematosus, dermatomyositis, connective tissue disease
• Endocrine disorders and cancer patients Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VSEL Max; We carried out the subdermal application of VSELs with a 1-mL syringe (90,000 cells in 0.4 mL plate-rich plasma) coupled to a 30-gauge needle, in the left preauricular area (1-cm2 area), 2 cm distal from the tragus	Biological: Very small embryonic-like stem cell; We carried out the subdermal application of VSELs with a 1-mL syringe (volume, 0.4 mL) coupled to a 30-gauge needle, in the left preauricular area (1-cm2 area), 2 cm distal from the tragus; Other Names: VSEL
Experimental: VSEL Medium; We carried out the subdermal application of VSELs with a 1-mL syringe (60,000 cells in 0.4 mL plate-rich plasma) coupled to a 30-gauge needle, in the left preauricular area (1-cm2 area), 2 cm distal from the tragus	Biological: Very small embryonic-like stem cell; We carried out the subdermal application of VSELs with a 1-mL syringe (volume, 0.4 mL) coupled to a 30-gauge needle, in the left preauricular area (1-cm2 area), 2 cm distal from the tragus; Other Names: VSEL
Experimental: VSEL Mini; We carried out the subdermal application of VSELs with a 1-mL syringe (30,000 cells in 0.4 mL plate-rich plasma) coupled to a 30-gauge needle, in the left preauricular area (1-cm2 area), 2 cm distal from the tragus	Biological: Very small embryonic-like stem cell; We carried out the subdermal application of VSELs with a 1-mL syringe (volume, 0.4 mL) coupled to a 30-gauge needle, in the left preauricular area (1-cm2 area), 2 cm distal from the tragus; Other Names: VSEL
No Intervention: Control; Subcutaneous injection of 0.4 mL platelet-rich plasma in the same part of the experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events	Swelling in the skin at the injection site	1 week
Incidence of treatment-emergent adverse events	Color change, pain in the skin at the injection site	1 week
Incidence of treatment-emergent adverse events	Pain in the skin at the injection site	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term changes in skin histopathology	Two 0.5 × 1 cm fragments of skin and subcutaneous tissue was removed from the bilateral preauricular areas for morphologic analysis by optical and electron microscopy	3-6 months after injection
Long-term changes in skin histopathology	Two 0.5 × 1 cm fragments of skin and subcutaneous tissue was removed from the bilateral preauricular areas for morphologic analysis by optical and electron microscopy	12 months after final injection

Collaborators and Investigators

• Sponsor: Fuda Cancer Hospital, Guangzhou
• Collaborators: Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2019
• Primary Completion (Actual): May 20, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Inflammation; Dermatitis
• Other Study ID Numbers: VSEL-face

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No