Very Small Embryonic-like Stem Cells for Ovary

NCT03985462 | Withdrawn Phase 1

• 1 other identifier: VSEL-ovary
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplant Complications; Premature Ovarian Failure

Outcome Measures

Primary Outcomes (1)

• Concentration of Blood female hormones level

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

  1 month after injection

Secondary Outcomes (4)

• Concentration of Blood female hormones level

  6 months after injection

• Incidence of amenorrhea

  6 months after injection

• Concentration of Blood female hormones level

  12 months after injection

• Incidence of amenorrhea

  12 months after injection

Study Arms (4)

VSEL Max

EXPERIMENTAL

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

VSEL Medium

EXPERIMENTAL

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

VSEL Mini

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

very small embryonic-like stem cell BIOLOGICAL

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

Also known as: VSEL

VSEL Max; VSEL Medium; VSEL Mini

Eligibility Criteria

• Age: 30 Years - 40 Years
• Gender Eligibility Details: Only female patients are enrolled in this research
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who are diagnosed as premature ovarian failure by professional doctor.
• Those have clear abnormal sex hormone levels

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Guangzhou Four-Leaf Clover HealthTech Co., Ltd.: collaborator

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The number of patients enrolled and the number of injected cells were randomly selected by the investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 1, 2019
• First Posted: June 13, 2019
• Study Start: July 3, 2019
• Primary Completion: May 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)