Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

Stem Cell Transplant Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03976206
• Other study ID #: VSEL-face
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 6, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: June 2019
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Inflammation
• Skin Inflammation
• Stem Cell Transplant Complications

Intervention

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

Locations

Country	Name	City	State
China	Biological treatment center in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events	Swelling in the skin at the injection site	1 week
Primary	Incidence of treatment-emergent adverse events	Color change, pain in the skin at the injection site	1 week
Primary	Incidence of treatment-emergent adverse events	Pain in the skin at the injection site	1 week
Secondary	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
Secondary	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