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The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency

Primary Purpose

Premature Ovarian Failure

Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
hucMSCs
Sponsored by
Sclnow Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ovarian Failure focused on measuring Premature Ovarian Failure, Premature Ovarian Insufficiency, mesenchymal stem cell

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet diagnostic criteria of European Society of Human Reproduction and Embryology
  • No hormonotherapy and chinese traditional medicine within 3 months;
  • Understand and sign informed consent.

Exclusion Criteria:

  • Patient with congenital adrenocortical hyperplasia;
  • Patient with Cushing syndrome;
  • Patient with Thyroid dysfunction;
  • Patient with hyperprolactinemia;
  • Patient with pituitary amenorrhea or hypothalamic amenorrhea;
  • Patient with HIV, hepatitis;
  • Gene defect (eg. Turner syndrome, fragile X syndrome)
  • Serious drug allergy history;
  • Suffering from thrombophlebitis, thromboembolism including venous thrombosis and arterial thrombosis;
  • History of treatment of ovarian cysts or ovarian surgery
  • With high tumor marker;
  • Pregnant or lactating
  • Receive other treatments that may affect the efficacy and safety of stem cells;
  • Do not understand or without sign informed consent;
  • The attending physician believes that it is not suitable for participating in this trial

Sites / Locations

  • Henan Provincial People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

High dose group

Medium dose group

Low dose group

Arm Description

Intravenous infusion with hucMSCs, 9*10^7 cells, 30ml

Intravenous infusion with hucMSCs, 6*10^7 cells, 30ml

Intravenous infusion with hucMSCs, 3*10^7 cells, 30ml

Outcomes

Primary Outcome Measures

Menstrual changes
Observe the change of patients with irregular menstrual cycle

Secondary Outcome Measures

Kupperman score
Mild: <14; moderate: 14-26; serious: >26
hormone level
Test the level change of Follicle-Stimulating Hormone (FSH), estrogen (E2), and Anti Mullerian Hormone (AMH)
Follicular development
Observe the size of ovarian follicles in each cycle.

Full Information

First Posted
January 17, 2019
Last Updated
April 11, 2023
Sponsor
Sclnow Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03816852
Brief Title
The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency
Official Title
Clinical Study on the Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Suspended
Why Stopped
Others
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sclnow Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Evaluate the safety of human umbilical cord mesenchymal stem cells (hucMSCs) in POI treatment; Evaluate the effective hucMSCs in POI treatment. Compare different infusion mode, meanwhile compare with hormone replacement therapy (HRT) withdrawal, so that assessing the stem cell therapy.
Detailed Description
Premature ovarian insufficiency (POI) or premature ovarian failure (POF), is the loss of function of the ovaries before age 40, which has the features of menstrual disorder with high gonadotropic hormone and low estrogen. The morbidity of POI is about 0.1% among woman before 40 years, 10-28% among woman with primary amenorrhea, and 4-18% among woman with secondary amenorrhea. Recent years research shows different sources of stem cell could be used to POI, and with effective results. Above all, this experiment designed to as a single center, random, and control experiment. treat POI patients wit human umbilical cord mesenchymal stem cells (MSCs). After regular follow-up and analysis, assessing the safety and effective of MSCs in POI treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Failure
Keywords
Premature Ovarian Failure, Premature Ovarian Insufficiency, mesenchymal stem cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose group
Arm Type
Experimental
Arm Description
Intravenous infusion with hucMSCs, 9*10^7 cells, 30ml
Arm Title
Medium dose group
Arm Type
Experimental
Arm Description
Intravenous infusion with hucMSCs, 6*10^7 cells, 30ml
Arm Title
Low dose group
Arm Type
Experimental
Arm Description
Intravenous infusion with hucMSCs, 3*10^7 cells, 30ml
Intervention Type
Biological
Intervention Name(s)
hucMSCs
Intervention Description
Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion
Primary Outcome Measure Information:
Title
Menstrual changes
Description
Observe the change of patients with irregular menstrual cycle
Time Frame
270 days
Secondary Outcome Measure Information:
Title
Kupperman score
Description
Mild: <14; moderate: 14-26; serious: >26
Time Frame
270 days
Title
hormone level
Description
Test the level change of Follicle-Stimulating Hormone (FSH), estrogen (E2), and Anti Mullerian Hormone (AMH)
Time Frame
270 days
Title
Follicular development
Description
Observe the size of ovarian follicles in each cycle.
Time Frame
270 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet diagnostic criteria of European Society of Human Reproduction and Embryology No hormonotherapy and chinese traditional medicine within 3 months; Understand and sign informed consent. Exclusion Criteria: Patient with congenital adrenocortical hyperplasia; Patient with Cushing syndrome; Patient with Thyroid dysfunction; Patient with hyperprolactinemia; Patient with pituitary amenorrhea or hypothalamic amenorrhea; Patient with HIV, hepatitis; Gene defect (eg. Turner syndrome, fragile X syndrome) Serious drug allergy history; Suffering from thrombophlebitis, thromboembolism including venous thrombosis and arterial thrombosis; History of treatment of ovarian cysts or ovarian surgery With high tumor marker; Pregnant or lactating Receive other treatments that may affect the efficacy and safety of stem cells; Do not understand or without sign informed consent; The attending physician believes that it is not suitable for participating in this trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guangzhi Liu, Dr
Organizational Affiliation
Henan Provincial People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China

12. IPD Sharing Statement

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The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency

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