Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

NCT ID: NCT03976206

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-06

Study Completion Date

2020-07-01

Brief Summary

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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

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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.

Conditions

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Stem Cell Transplant Complications Skin Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The volunteers will be randomly arranged to enter the experimental group or the control group.

Study Groups

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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

Group Type EXPERIMENTAL

Very small embryonic-like stem cell

Intervention Type 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

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

Group Type EXPERIMENTAL

Very small embryonic-like stem cell

Intervention Type 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

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

Group Type EXPERIMENTAL

Very small embryonic-like stem cell

Intervention Type 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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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VSEL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Fuda Cancer Hospital, Guangzhou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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VSEL-face

Identifier Type: -

Identifier Source: org_study_id

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