Very Small Embryonic-like Stem Cells for Ovary

NCT ID: NCT03985462

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-03

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Stem Cell Transplant Complications Premature Ovarian Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The number of patients enrolled and the number of injected cells were randomly selected by the investigator

Study Groups

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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

Group Type EXPERIMENTAL

very small embryonic-like stem cell

Intervention Type BIOLOGICAL

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

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

Group Type EXPERIMENTAL

very small embryonic-like stem cell

Intervention Type BIOLOGICAL

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

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

Group Type EXPERIMENTAL

very small embryonic-like stem cell

Intervention Type BIOLOGICAL

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

Control

5 mL plate-rich plasma with no cells inside were injected into the bilateral fallopian tubes as a control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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VSEL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Fuda Cancer Hospital, Guangzhou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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VSEL-ovary

Identifier Type: -

Identifier Source: org_study_id

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