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Mesenchymal Stem Cells (MSCs) - Like Cell Transplantation in Women With Primary Ovarian Insufficiency (MSCLCTWPOI)

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ClinicalTrials.gov Identifier: NCT03877471
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
The First Affiliated Hospital of Zhengzhou University
National Natural Science Foundation of China
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). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of MSC-like cell therapy in women suffering from POI.

Condition or disease Intervention/treatment Phase
Primary Ovarian Insufficiency Genetic: Cell therapy Phase 1

Detailed Description:
The purpose of this work is to explore the safety and preliminary efficacy of human embryonic stem cell derived MSC-like cell transplantation in women with POI. MSC-like cells were injected directly into bilateral ovaries under transvaginal ultrasound. Patients are subjected into 3 groups, with low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells injection for each ovary. The outcomes of patients were followed after the injection every 2 weeks. The investigator mainly follow the safety indexes, and the level of sex hormone and signs of follicle growth will also be monitored. The growing follicles will be stimulated by exogenous hormone, followed by oocyte retrieval and in vitro fertilization (IVF).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Patients will be subjected into 3 groups, with a low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells transplantation for each ovary. The investigator will first carry out the low dosage group, and then the medium dosage group, based on the safety evaluation of the previous group, the high dosage group will be executed in the same way.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Stem Cell (MSC)-Like Cells Transplantation in Women With Primary Ovarian Insufficiency (POI)
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: Low dosage
The low dosage will inject 2 million MSC-like cells (in 100ul suspension) for each ovary.
Genetic: Cell therapy
Ovary injection with MSC-like cells through transvaginal ultrasound,3 injection points for each ovary.

Experimental: Medium dosage
The medium dosage will inject 5 million MSC-like cells (in 100ul suspension) for each ovary.
Genetic: Cell therapy
Ovary injection with MSC-like cells through transvaginal ultrasound,3 injection points for each ovary.

Experimental: High dosage
The high dosage will inject 10 million MSC-like cells (in 100ul suspension) for each ovary.
Genetic: Cell therapy
Ovary injection with MSC-like cells through transvaginal ultrasound,3 injection points for each ovary.




Primary Outcome Measures :
  1. Temperature [ Time Frame: 0-24 weeks ]
    Body temperature of the participants will be measured fortnightly after injection.

  2. Pulse [ Time Frame: 0-24 weeks ]
    Pulse of the participants will be measured fortnightly after injection.

  3. Breaths per minute [ Time Frame: 0-24 weeks ]
    Breathing rate of the participants will be measured fortnightly after injection.

  4. Blood pressure [ Time Frame: 0-24 weeks ]
    Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.


Secondary Outcome Measures :
  1. Number of antral follicle [ Time Frame: 0-24 weeks ]
    The number of antral follicles developing will be recorded by transvaginal ultrasound fortnightly after injection.

  2. Follicle-stimulating hormone (FSH) serum level [ Time Frame: 0-24 weeks ]
    Serum FSH level will be tested fortnightly after injection.

  3. Estradiol (E2) serum level [ Time Frame: 0-24 weeks ]
    Serum E2 level will be tested fortnightly after injection.

  4. Anti-Mullerian hormone (AMH) serum level [ Time Frame: 0-24 weeks ]
    Serum AMH level will be tested fortnightly after injection.

  5. Ovarian volume [ Time Frame: 0-24 weeks ]
    The ovarian volume will be recorded fortnightly by transvaginal ultrasound after injection.



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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female will be enrolled.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Under 40 years of age;
  2. Have established regular menstrual cycle, oligomenorrhea / amenorrhea ≥ 4 months;
  3. FSH (Follicle-Stimulating Hormone) > 25 IU/mL;
  4. Bilateral ovaries are visible by ultrasound;
  5. Have fertility requirement, husband has sperms;
  6. Willing to sign the Informed Consent Form.

Exclusion Criteria:

  1. Primary amenorrhea;
  2. History of serious drug allergy or allergic constitution;
  3. Thrombophlebitis and thromboembolia, past and present;
  4. Acute or chronic infection, hematologic disease, angiocardiopathy, pulmonary disease, liver disease, nephropathy, pancreas disease
  5. Autoimmune disease, history of severe familial genetic disease, etc.
  6. Anatomical abnormality of reproductive system;
  7. Contraindications for pregnancy;
  8. Spouse azoospermia;
  9. HIV+, hepatitis B, C;
  10. Thyroid dysfunction;
  11. History of previous malignant or ovarian tumors, history of ovarian therapy;
  12. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
  13. During pregnancy or lactation;
  14. Alcohol or other substance abuse;
  15. Mental disease, communicate obstruction;
  16. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
  17. Attending doctor consider inappropriate to take part in.

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): NCT03877471


Contacts
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Contact: Long Yan, Doctor 8617503296371 yanlong@ioz.ac.cn
Contact: Bo Sun, Doctor 8617803879015 Sun.bo1224@163.com

Locations
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China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Linli Hu, Doctor    8615890619576    hulinli1999@163.com   
Sponsors and Collaborators
Chinese Academy of Sciences
The First Affiliated Hospital of Zhengzhou University
National Natural Science Foundation of China
Investigators
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Principal Investigator: Hongmei Wang, Doctor Institute of zoology, Chinese Academy of Sciences

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Responsible Party: Hongmei Wang, Professor, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT03877471     History of Changes
Other Study ID Numbers: IOZ ChineseAS POI-2
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigator have not recruited enough participant yet, till now, most of them would like to keep the individual participant data classified.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hongmei Wang, Chinese Academy of Sciences:
Mesenchymal stem cell
Transplantation
Human embryonic stem cell
Premature ovarian failure
Additional relevant MeSH terms:
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Primary Ovarian Insufficiency
Gonadal Dysgenesis
Ovarian Diseases
Urogenital Abnormalities
Congenital Abnormalities
Cardiovascular Abnormalities
Menopause, Premature
Turner Syndrome
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn