Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

NCT03976206 | Withdrawn Phase 1 DMC

• 1 other identifier: VSEL-face
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplant Complications; Skin Inflammation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Short-term changes in skin histopathology

  3-6 months after injection

• Long-term changes in skin histopathology

  12 months after final injection

Study Arms (4)

VSEL Max

EXPERIMENTAL

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

VSEL Medium

EXPERIMENTAL

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

VSEL Mini

EXPERIMENTAL

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

Control

NO INTERVENTION

Subcutaneous injection of 0.4 mL platelet-rich plasma in the same part of the experimental group

Interventions

Very small embryonic-like stem cell BIOLOGICAL

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

Also known as: VSEL

VSEL Max; VSEL Medium; VSEL Mini

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers with anti-aging willingness

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Guangzhou Four-Leaf Clover HealthTech Co., Ltd.: collaborator

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The volunteers will be randomly arranged to enter the experimental group or the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In the experimental group, VSELs will be injected in left preauricular area of every volunteer, followed by skin pathology to compare the improvement of skin aging with the skin of right preauricular area. In the control group, platelet-rich plasma will be injected to the left preauricular area of every volunteer.

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 5, 2019
• Study Start: July 6, 2019
• Primary Completion: May 20, 2020
• Study Completion: July 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)