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Very Small Embryonic-like Stem Cells for Ovary

Sponsor
Fuda Cancer Hospital, Guangzhou (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03985462
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 premature ovarian failure.

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Interventional
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 solventPatients 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 :
Jul 3, 2019
Actual Primary Completion Date :
May 30, 2020
Actual Study Completion Date :
Jun 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 [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 [6 months after injection]

      Check whether blood FSH, LH and E2 levels return to normal

    2. Incidence of amenorrhea [6 months after injection]

      Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound

    3. Concentration of Blood female hormones level [12 months after injection]

      Check whether blood FSH, LH and E2 levels return to normal

    4. Incidence of amenorrhea [12 months after injection]

      Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    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:
    NCT03985462
    Other Study ID Numbers:
    • VSEL-ovary
    First Posted:
    Jun 13, 2019
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    May 1, 2020
    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:
    Premature Birth
    Primary Ovarian Insufficiency
    Menopause, Premature

    Study Results

    No Results Posted as of Oct 19, 2020