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Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)

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ClinicalTrials.gov Identifier: NCT03033277
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
The Third Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Hongmei Wang, Chinese Academy of Sciences

Brief Summary:
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer, and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been previously documented. Herein the purpose of this work is to evaluate the therapeutic potential of cell therapy in women suffering from POI.

Condition or disease Intervention/treatment Phase
Primary Ovarian Insufficiency Biological: Placebo transplantation Biological: HUC-MSCs transplantation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
Actual Study Start Date : February 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
Placebo Comparator: Control group
Hormone replacement therapy, placebo transplantation.
Biological: Placebo transplantation
Intraovarian injection of placebo through vagina under the guidance of ultrasonic.

Experimental: Experimental group
Hormone replacement therapy,HUC-MSCs transplantation.
Biological: HUC-MSCs transplantation
Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.




Primary Outcome Measures :
  1. Number of mature follicle [ Time Frame: Up to 4 months ]
    The number of mature follicles developing was recorded by transvaginal ultrasound scan


Secondary Outcome Measures :
  1. Follicle-stimulating hormone (FSH) serum level [ Time Frame: Up to 4 months ]
    Serum FSH level was evaluated once a month after surgery

  2. Estradiol (E2) serum level [ Time Frame: Up to 4 months ]
    Serum E2 level was evaluated once a month after surgery

  3. Anti-Mullerian hormone (AMH) serum level [ Time Frame: Up to 4 months ]
    Serum AMH level was evaluated once a month after surgery

  4. Number of antral follicle development [ Time Frame: Up to 4 months ]
    The number of antral follicles developing was recorded by transvaginal ultrasound scan

  5. Ovarian volume [ Time Frame: Up to 4 months ]
    The ovarian volume was recorded by transvaginal ultrasound scan

  6. Pregnancy rate [ Time Frame: Up to 12 months ]
    The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed with primary ovarian insufficiency;
  2. Women between 20 and 40 years;
  3. Have fertility requirements, husband has sperm;
  4. Willing to sign the Informed Consent Form.

Exclusion Criteria:

  1. Primary amenorrhea;
  2. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
  3. Thyroid dysfunction;
  4. Severe endometriosis;
  5. Contraindications for pregnancy;
  6. Prior personal history of ovarian cancer;
  7. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
  8. History of serious drug allergy or allergic constitution;
  9. Autoimmune disease, history of severe familial genetic disease;
  10. HIV+, hepatitis B, C;

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): NCT03033277


Contacts
Contact: Long Yan, Doctor +86-15650717331 yanlong@ioz.ac.cn
Contact: Jianqiao Liu, Doctor +86-18928916736 ljq88gz@163.com

Locations
China, Beijing
Institute of Zoology, Chinese Academy of Sciences. Recruiting
Beijing, Beijing, China, 100101
Contact: Jianqiao Liu, Doctor    +86-18928916736    ljq88gz@163.com   
Contact: Yixuan Wu, Doctor    +86-13430202696    87295667@qq.com   
Sponsors and Collaborators
Chinese Academy of Sciences
The Third Affiliated Hospital of Guangzhou Medical University
Investigators
Principal Investigator: Hongmei Wang, Doctor State Key Laboratory of Stem Cell and Reproductive Biology

Responsible Party: Hongmei Wang, Professor, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT03033277     History of Changes
Other Study ID Numbers: Multi-cited POI Recovery
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Primary Ovarian Insufficiency
Menopause, Premature
Gonadal Dysgenesis
Turner Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn