Very Small Embryonic-like Stem Cells for Ovary

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

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

Study Overview

• Status: Withdrawn
• Conditions: Premature Ovarian Failure; Stem Cell Transplant Complications
• Intervention / Treatment: Biological: very small embryonic-like stem cell

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Biological treatment center in Fuda cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: VSEL
Experimental: 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	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; Other Names: VSEL
Experimental: 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	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; Other Names: VSEL
No Intervention: Control; 5 mL plate-rich plasma with no cells inside were injected into the bilateral fallopian tubes as a control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Blood female hormones level	Check whether blood FSH, LH and E2 levels return to normal	1 month after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Blood female hormones level	Check whether blood FSH, LH and E2 levels return to normal	6 months after injection
Incidence of amenorrhea	Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound	6 months after injection
Concentration of Blood female hormones level	Check whether blood FSH, LH and E2 levels return to normal	12 months after injection
Incidence of amenorrhea	Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound	12 months after injection

Collaborators and Investigators

• Sponsor: Fuda Cancer Hospital, Guangzhou
• Collaborators: Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: June 1, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: VSEL-ovary

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No