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Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

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ClinicalTrials.gov Identifier: NCT03976206
Recruitment Status : Withdrawn (Policy changes have contributed to the failure to carry out smoothly)
First Posted : June 5, 2019
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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
Stem Cell Transplant Complications Skin Inflammation 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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : July 6, 2019
Actual Primary Completion Date : May 20, 2020
Actual Study Completion Date : July 1, 2020

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 Name: 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 Name: 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 Name: VSEL

No Intervention: Control
Subcutaneous injection of 0.4 mL platelet-rich plasma in the same part of the experimental group



Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: 1 week ]
    Swelling in the skin at the injection site

  2. Incidence of treatment-emergent adverse events [ Time Frame: 1 week ]
    Color change, pain in the skin at the injection site

  3. Incidence of treatment-emergent adverse events [ Time Frame: 1 week ]
    Pain in the skin at the injection site


Secondary Outcome Measures :
  1. Short-term changes in skin histopathology [ Time Frame: 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 [ Time Frame: 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



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976206


Locations
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China, Guangdong
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.
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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT03976206    
Other Study ID Numbers: VSEL-face
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis
Inflammation
Pathologic Processes
Skin Diseases