Very Small Embryonic-like Stem Cells for Ovary

Fuda Cancer Hospital, Guangzhou

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Stem Cell Transplant Complications; Premature Ovarian Failure

Treatments: Biological: very small embryonic-like stem cell

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03985462

VSEL-ovary

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 30 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 4 patient groups

VSEL Max

Experimental group

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

Treatment:

Biological: very small embryonic-like stem cell

VSEL Medium

Experimental group

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

Treatment:

Biological: very small embryonic-like stem cell

VSEL Mini

Experimental group

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

Treatment:

Biological: very small embryonic-like stem cell

Control

No Intervention group

Description:

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