Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

Phase 1

Withdrawn

• Conditions: Stem Cell Transplant Complications; Skin Inflammation
• Interventions: Biological: Very small embryonic-like stem cell

• Registration Number: NCT03976206
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-05-31
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-05
• Study Start: 2019-07-06
• Primary Completion: 2020-05-20
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VSEL Medium	Very small embryonic-like stem cell	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
VSEL Max	Very small embryonic-like stem cell	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
VSEL Mini	Very small embryonic-like stem cell	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

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	1 week	Pain in the skin at the injection site

Secondary Outcome Measures

Name	Time	Method
Long-term changes in skin histopathology	12 months after final injection	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
Short-term changes in skin histopathology	3-6 months after injection	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

Trial Locations

Locations (1)

Biological treatment center in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China