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Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

Primary Purpose

Stem Cell Transplant Complications, Skin Inflammation

Status

Withdrawn

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Very small embryonic-like stem cell

About this trial

This is an interventional treatment trial for Stem Cell Transplant Complications

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Biological treatment center in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

VSEL Max

VSEL Medium

VSEL Mini

Control

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events

Swelling in the skin at the injection site

Incidence of treatment-emergent adverse events

Color change, pain in the skin at the injection site

Incidence of treatment-emergent adverse events

Pain in the skin at the injection site

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT03976206

First Posted

May 31, 2019

Last Updated

October 13, 2020

Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03976206

Brief Title

Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Policy changes have contributed to the failure to carry out smoothly

Study Start Date

July 6, 2019 (Actual)

Primary Completion Date

May 20, 2020 (Actual)

Study Completion Date

July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stem Cell Transplant Complications, Skin Inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Investigator

Masking Description

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

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VSEL Max

Arm Type

Experimental

Arm Description

Arm Title

VSEL Medium

Arm Type

Experimental

Arm Description

Arm Title

VSEL Mini

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Very small embryonic-like stem cell

Other Intervention Name(s)

VSEL

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse events

Description

Swelling in the skin at the injection site

Time Frame

1 week

Title

Incidence of treatment-emergent adverse events

Description

Color change, pain in the skin at the injection site

Time Frame

1 week

Title

Incidence of treatment-emergent adverse events

Description

Pain in the skin at the injection site

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Short-term changes in skin histopathology

Description

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

Time Frame

3-6 months after injection

Title

Long-term changes in skin histopathology

Description

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

Time Frame

12 months after final injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Biological treatment center in Fuda cancer hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

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