Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 12 for:    Premature Ovarian Failure 14

The Safety and Efficiency Study of Mesenchymal Stem Cell in Premature Ovarian Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03816852
Recruitment Status : Active, not recruiting
First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sclnow Biotechnology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Premature Ovarian Failure Biological: hucMSCs Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Study on the Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High dose group
Intravenous infusion with hucMSCs, 9*10^7 cells, 30ml
Biological: hucMSCs
Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

Experimental: Medium dose group
Intravenous infusion with hucMSCs, 6*10^7 cells, 30ml
Biological: hucMSCs
Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

Experimental: Low dose group
Intravenous infusion with hucMSCs, 3*10^7 cells, 30ml
Biological: hucMSCs
Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion




Primary Outcome Measures :
  1. Menstrual changes [ Time Frame: 270 days ]
    Observe the change of patients with irregular menstrual cycle


Secondary Outcome Measures :
  1. Kupperman score [ Time Frame: 270 days ]
    Mild: <14; moderate: 14-26; serious: >26

  2. hormone level [ Time Frame: 270 days ]
    Test the level change of Follicle-Stimulating Hormone (FSH), estrogen (E2), and Anti Mullerian Hormone (AMH)

  3. Follicular development [ Time Frame: 270 days ]
    Observe the size of ovarian follicles in each cycle.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816852


Locations
Layout table for location information
China, Henan
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Sponsors and Collaborators
Sclnow Biotechnology Co., Ltd.
Investigators
Layout table for investigator information
Study Director: Guangzhi Liu, Dr Henan Provincial Hospital

Layout table for additonal information
Responsible Party: Sclnow Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03816852     History of Changes
Other Study ID Numbers: SCLnow-HNRM-01
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sclnow Biotechnology Co., Ltd.:
Premature Ovarian Failure
Premature Ovarian Insufficiency
mesenchymal stem cell
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Ovarian Diseases
Obstetric Labor Complications
Pregnancy Complications
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases