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Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

Sponsor
Fuda Cancer Hospital, Guangzhou (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03976206
Collaborator
Guangzhou Four-Leaf Clover HealthTech Co., Ltd. (Industry)
0
Enrollment
1
Location
4
Arms
11.9
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Very small embryonic-like stem cell
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Single (Investigator)
Masking Description:
The volunteers will be randomly arranged to enter the experimental group or the control group.
Primary Purpose:
Treatment
Official Title:
Autologous Very Small Embryonic-like Stem Cells(VSELs) for Facial Skin Antiaging
Actual Study Start Date :
Jul 6, 2019
Actual Primary Completion Date :
May 20, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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
Other Names:
  • VSEL

    		•
    Experimental: 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

    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
    Other Names:
  • VSEL

    		•
    Experimental: 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

    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
    Other Names:
  • VSEL

    		•
    No Intervention: Control

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

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment-emergent adverse events [1 week]

      Swelling in the skin at the injection site

    2. Incidence of treatment-emergent adverse events [1 week]

      Color change, pain in the skin at the injection site

    3. Incidence of treatment-emergent adverse events [1 week]

      Pain in the skin at the injection site

    Secondary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Biological treatment center in Fuda cancer hospital Guangzhou Guangdong China 510000

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fuda Cancer Hospital, Guangzhou
    ClinicalTrials.gov Identifier:
    NCT03976206
    Other Study ID Numbers:
    • VSEL-face
    First Posted:
    Jun 5, 2019
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dermatitis
    Inflammation

    Study Results

    No Results Posted as of Oct 19, 2020