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Very Small Embryonic-like Stem Cells for Ovary

Primary Purpose

Stem Cell Transplant Complications, Premature Ovarian Failure

Status

Withdrawn

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

very small embryonic-like stem cell

About this trial

This is an interventional treatment trial for Stem Cell Transplant Complications

Eligibility Criteria

30 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Biological treatment center in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

VSEL Max

VSEL Medium

VSEL Mini

Control

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Concentration of Blood female hormones level

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

Secondary Outcome Measures

Concentration of Blood female hormones level

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

Incidence of amenorrhea

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

Concentration of Blood female hormones level

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

Incidence of amenorrhea

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

Full Information

NCT ID

NCT03985462

First Posted

June 1, 2019

Last Updated

October 13, 2020

Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03985462

Brief Title

Very Small Embryonic-like Stem Cells for Ovary

Official Title

Autologous Very Small Embryonic-like Stem Cells(VSELs) for Premature Ovarian Failure

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Policy changes have contributed to the failure to carry out smoothly

Study Start Date

July 3, 2019 (Actual)

Primary Completion Date

May 30, 2020 (Actual)

Study Completion Date

June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stem Cell Transplant Complications, Premature Ovarian Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

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

Investigator

Masking Description

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

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VSEL Max

Arm Type

Experimental

Arm Description

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

Arm Title

VSEL Medium

Arm Type

Experimental

Arm Description

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

Arm Title

VSEL Mini

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

very small embryonic-like stem cell

Other Intervention Name(s)

VSEL

Intervention Description

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

Primary Outcome Measure Information:

Title

Concentration of Blood female hormones level

Description

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

Time Frame

1 month after injection

Secondary Outcome Measure Information:

Title

Concentration of Blood female hormones level

Description

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

Time Frame

6 months after injection

Title

Incidence of amenorrhea

Description

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

Time Frame

6 months after injection

Title

Concentration of Blood female hormones level

Description

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

Time Frame

12 months after injection

Title

Incidence of amenorrhea

Description

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

Time Frame

12 months after injection

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Only female patients are enrolled in this research

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Biological treatment center in Fuda cancer hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Very Small Embryonic-like Stem Cells for Ovary

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