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出境医 / 临床实验 / Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

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
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.
Study Design
Layout table for study information
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
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 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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
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.
Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE July 6, 2019
Actual Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Incidence of treatment-emergent adverse events [ Time Frame: 1 week ]
    Swelling in the skin at the injection site
  • Incidence of treatment-emergent adverse events [ Time Frame: 1 week ]
    Color change, pain in the skin at the injection site
  • Incidence of treatment-emergent adverse events [ Time Frame: 1 week ]
    Pain in the skin at the injection site
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Very Small Embryonic-like Stem Cells for Facial Skin Antiaging
Official Title  ICMJE Autologous Very Small Embryonic-like Stem Cells(VSELs) for Facial Skin Antiaging
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Stem Cell Transplant Complications
  • Skin Inflammation
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Biological: Very small embryonic-like stem cell
  • 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
    Intervention: Biological: Very small embryonic-like stem cell
  • 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
    Intervention: Biological: Very small embryonic-like stem cell
  • No Intervention: Control
    Subcutaneous injection of 0.4 mL platelet-rich plasma in the same part of the experimental group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 13, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2019) 		20
Actual Study Completion Date  ICMJE July 1, 2020
Actual Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03976206
Other Study ID Numbers  ICMJE VSEL-face
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fuda Cancer Hospital, Guangzhou
Study Sponsor  ICMJE Fuda Cancer Hospital, Guangzhou
Collaborators  ICMJE Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
Investigators  ICMJE Not Provided
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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