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Very Small Embryonic-like Stem Cells for Ovary

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ClinicalTrials.gov Identifier: NCT03985462
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Study Start Date : June 30, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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



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



Information from the National Library of Medicine

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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

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): NCT03985462


Contacts
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Contact: Jibing Chen, PhD +86-18903068207 jibingchen398@163.com

Locations
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China, Guangdong
Biological treatment center in Fuda cancer hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Chen Jibing, PhD    +86-18903068207    jibingchen398@163.com   
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: NCT03985462     History of Changes
Other Study ID Numbers: VSEL-ovary
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
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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Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases