Very Small Embryonic-like Stem Cells for Ovary

Stem Cell Transplant Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03985462
• Other study ID #: VSEL-ovary
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 3, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2020
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency
• Stem Cell Transplant Complications

Intervention

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

Locations

Country	Name	City	State
China	Biological treatment center in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Blood female hormones level	Check whether blood FSH, LH and E2 levels return to normal	1 month after injection
Secondary	Concentration of Blood female hormones level	Check whether blood FSH, LH and E2 levels return to normal	6 months after injection
Secondary	Incidence of amenorrhea	Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound	6 months after injection
Secondary	Concentration of Blood female hormones level	Check whether blood FSH, LH and E2 levels return to normal	12 months after injection
Secondary	Incidence of amenorrhea	Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound	12 months after injection