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出境医 / 临床实验 / Very Small Embryonic-like Stem Cells for Ovary

Very Small Embryonic-like Stem Cells for Ovary

Study Description
Brief Summary:
The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to premature ovarian failure.

Condition or disease Intervention/treatment Phase
Stem Cell Transplant Complications Premature Ovarian Failure Biological: very small embryonic-like stem cell Phase 1 Phase 2

Detailed Description:
Premature ovarian failure is diagnosed by blood femal hormones test of follicle stimulating hormone (FSH, > 40 IU/L)、luteinizing hormon (LH, > 40 IU/L)、estradiol (E2, > 100pg/mL) and/or amenorrhea before the age of 40. VSELs come from the patient's periperal blood, and will be injected in bilateral oviducts, followed-up by hormone testing and menstrual conditions.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with confirmed premature ovarian failure were divided into three groups, each group was injected with different numbers of VSEL cells, and the control group was injected with platelet-rich serum which is the cell solvent
Masking: Single (Investigator)
Masking Description: The number of patients enrolled and the number of injected cells were randomly selected by the investigator
Primary Purpose: Treatment
Official Title: Autologous Very Small Embryonic-like Stem Cells(VSELs) for Premature Ovarian Failure
Actual Study Start Date : July 3, 2019
Actual Primary Completion Date : May 30, 2020
Actual Study Completion Date : June 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: VSEL Max
A total of 300,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a high dose group
 Biological: very small embryonic-like stem cell
Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation
Other Name: VSEL
Experimental: VSEL Medium
A total of 200,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a middle dose group
 Biological: very small embryonic-like stem cell
Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation
Other Name: VSEL
Experimental: VSEL Mini
A total of 100,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a low dose group
 Biological: very small embryonic-like stem cell
Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation
Other Name: VSEL
No Intervention: Control
5 mL plate-rich plasma with no cells inside were injected into the bilateral fallopian tubes as a control group
Outcome Measures
Primary Outcome Measures :
  1. Concentration of Blood female hormones level [ Time Frame: 1 month after injection ]
    Check whether blood FSH, LH and E2 levels return to normal


Secondary Outcome Measures :
  1. Concentration of Blood female hormones level [ Time Frame: 6 months after injection ]
    Check whether blood FSH, LH and E2 levels return to normal

  2. Incidence of amenorrhea [ Time Frame: 6 months after injection ]
    Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound

  3. Concentration of Blood female hormones level [ Time Frame: 12 months after injection ]
    Check whether blood FSH, LH and E2 levels return to normal

  4. Incidence of amenorrhea [ Time Frame: 12 months after injection ]
    Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female patients are enrolled in this research
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are diagnosed as premature ovarian failure by professional doctor.
  • Those have clear abnormal sex hormone levels

Exclusion Criteria:

  • Unmarried woman
  • Suffering from other serious gynecological diseases or gynecological tumors
  • Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin
Contacts and Locations

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.
Tracking Information
First Submitted Date  ICMJE June 1, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE July 3, 2019
Actual Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019) 		Concentration of Blood female hormones level [ Time Frame: 1 month after injection ]
Check whether blood FSH, LH and E2 levels return to normal
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Concentration of Blood female hormones level [ Time Frame: 6 months after injection ]
    Check whether blood FSH, LH and E2 levels return to normal
  • Incidence of amenorrhea [ Time Frame: 6 months after injection ]
    Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound
  • Concentration of Blood female hormones level [ Time Frame: 12 months after injection ]
    Check whether blood FSH, LH and E2 levels return to normal
  • Incidence of amenorrhea [ Time Frame: 12 months after injection ]
    Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound
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 Ovary
Official Title  ICMJE Autologous Very Small Embryonic-like Stem Cells(VSELs) for Premature Ovarian Failure
Brief Summary The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to premature ovarian failure.
Detailed Description Premature ovarian failure is diagnosed by blood femal hormones test of follicle stimulating hormone (FSH, > 40 IU/L)、luteinizing hormon (LH, > 40 IU/L)、estradiol (E2, > 100pg/mL) and/or amenorrhea before the age of 40. VSELs come from the patient's periperal blood, and will be injected in bilateral oviducts, followed-up by hormone testing and menstrual conditions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients with confirmed premature ovarian failure were divided into three groups, each group was injected with different numbers of VSEL cells, and the control group was injected with platelet-rich serum which is the cell solvent
Masking: Single (Investigator)
Masking Description:
The number of patients enrolled and the number of injected cells were randomly selected by the investigator
Primary Purpose: Treatment
Condition  ICMJE
  • Stem Cell Transplant Complications
  • Premature Ovarian Failure
Intervention  ICMJE Biological: very small embryonic-like stem cell
Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation
Other Name: VSEL
Study Arms  ICMJE
  • Experimental: VSEL Max
    A total of 300,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a high dose group
    Intervention: Biological: very small embryonic-like stem cell
  • Experimental: VSEL Medium
    A total of 200,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a middle dose group
    Intervention: Biological: very small embryonic-like stem cell
  • Experimental: VSEL Mini
    A total of 100,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a low dose group
    Intervention: Biological: very small embryonic-like stem cell
  • No Intervention: Control
    5 mL plate-rich plasma with no cells inside were injected into the bilateral fallopian tubes as a control 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 12, 2019) 		20
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who are diagnosed as premature ovarian failure by professional doctor.
  • Those have clear abnormal sex hormone levels

Exclusion Criteria:

  • Unmarried woman
  • Suffering from other serious gynecological diseases or gynecological tumors
  • Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only female patients are enrolled in this research
Ages  ICMJE 30 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT03985462
Other Study ID Numbers  ICMJE VSEL-ovary
Has Data Monitoring Committee No
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 May 2020

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

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