Very Small Embryonic-like Stem Cells for Ovary

Phase 1

Withdrawn

• Conditions: Stem Cell Transplant Complications; Premature Ovarian Failure
• Interventions: Biological: very small embryonic-like stem cell

• Registration Number: NCT03985462
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-06-01
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-13
• Study Start: 2019-07-03
• Status Verified: 2020-05
• Primary Completion: 2020-05-30
• Study Completion: 2020-06-30
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VSEL Max	very small embryonic-like stem cell	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
VSEL Medium	very small embryonic-like stem cell	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
VSEL Mini	very small embryonic-like stem cell	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

Primary Outcome Measures

Name	Time	Method
Concentration of Blood female hormones level	1 month after injection	Check whether blood FSH, LH and E2 levels return to normal

Secondary Outcome Measures

Name	Time	Method
Concentration of Blood female hormones level	12 months after injection	Check whether blood FSH, LH and E2 levels return to normal
Incidence of amenorrhea	12 months after injection	Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound

Trial Locations

Locations (1)

Biological treatment center in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China