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A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Failure (POF)

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: NCT02912104
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : March 1, 2023
Sponsor:
Collaborator:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Information provided by (Responsible Party):
Dongmei Lai, International Peace Maternity and Child Health Hospital

Study Description
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Brief Summary:
This project will clarify the safety and effectiveness of human amniotic epithelial cells transplantation for the treatment of primary ovarian failure (POF) patients and provide a new therapeutic method for patients with infertility.

Condition or disease Intervention/treatment Phase
Primary Ovarian Insufficiency Premature Ovarian Failure Infertility Biological: human amniotic epithelial cells (hAECs) transplantation Phase 1

Detailed Description:
POF is a defect characterized by the premature depletion of ovarian follicles. Patients with POF suffer from amenorrhea, infertility, low levels of estrogen, and high gonadotropin concentration before the age of 40. The early failure of ovarian function leads to lost fertility and increases risk of osteoporosis and cardiovascular disease, which has serious impact on the patient's physical, mental health and family stability. The etiology of POF is complex, and so far there has not been any effective treatment. Recent study showed that human amniotic epithelial cells (hAECs), also known as the birth waste, are newly discovered adult stem cells. The hAECs have the ability to repair nerve damage, myocardial injury, as well as liver damage. hAECs have low immunogenicity and no ethical restrictions. Therefore, hAECs are expected to become the new seed cells for regenerative medicine. Our previous study was the first to show that human amniotic epithelial cells have the ability to restore folliculogenesis in a mouse model with chemotherapy-induced premature ovarian failure. Our further studies demonstrated that hAECs either directly transdifferentiated into granulosa cells, or inhibited tumor necrosis factor-alpha-mediated granulosa cell apoptosis and reduced the inflammatory reaction in ovaries induced by chemotherapeutics, regulating VEGFA and its receptors to induce follicular growth related to paracrine activity. Therefore, it is necessary to start the clinical study of human amniotic epithelial cells transplantation in the POF disease which may offer a novel therapeutic strategy for improving the quality of life of POF patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Failure
Actual Study Start Date : June 20, 2020
Actual Primary Completion Date : January 5, 2022
Actual Study Completion Date : January 5, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: hAECs transplantation
To clarify the safety and effectiveness of human amniotic epithelial cells transplantation for the treatment of POF patients
 Biological: human amniotic epithelial cells (hAECs) transplantation
hAECs are prepared and cultured using GMP(Good Manufacturing Practice, GMP) rules, 3×10^7 hAECs in 4.5ml is separately injected into ovarian tissue by bilateral ovarian artery infusion.
Other Name: hAECs transplantation


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability assessed by Adverse Events [ Time Frame: 150 days ]
    Proportion of patients with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI，such as acute allergic reaction, ectopic mass formation related to treatment)


Secondary Outcome Measures :
  1. Change from baseline in bilateral ovarian volume [ Time Frame: 150 days ]
    The ovarian volume will be assessed by pelvic ultrasound on 30th, 90th, 150th days after transplantation.

  2. Change from baseline in number of antral follicles (AFC) [ Time Frame: 150 days ]
    The number of antral follicles developing will be assessed by pelvic ultrasound on 30th, 90th, 150th days after transplantation.

  3. Change from baseline in Follicle-stimulating hormone (FSH) serum level [ Time Frame: 150 days ]
    Serum FSH level will be tested on 30th and 150th days after transplantation.

  4. Change from baseline in Luteinizing hormone (LH), Estradiol (E2), Testosterone (T), Prolactin (PRL) , Anti-müllerian hormone (AMH) serum level [ Time Frame: 150 days ]
    Serum LH, E2, T, PRL, AMH level will be tested on 30th and 150th days after transplantation.

  5. Menstruation resumption [ Time Frame: 150 days ]
    Patients will monitor for resumption of menses within 150 days after transplantation. If the menstruation resumption rate is over 30%, the treatment will be considered effective.

  6. Endometrial thickness [ Time Frame: 150 days ]
    The endometrial thickness will be assessed by pelvic ultrasound on 30th, 90th, 150th days after transplantation.

  7. Bone mineral density (BMD) measurements [ Time Frame: 150 days ]
    The BMD will be tested on 150th day after transplantation.

  8. Achievement of pregnancy [ Time Frame: 12 Months ]

    Achievement of pregnancy by natural or assisted conception methods, such as in vitro fertilization (IVF). The outcomes of pregnancy include conception, miscarriage and delivery.

    If the pregnancy rate is over 30%, the treatment will be considered effective.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥18 and<45 years old.
  2. Female patients with documented diagnosis of POF: <40 years old, at least 4 months of amenorrhea not due to pregnancy, two FSH levels above 40 IU/L, at least one month apart.
  3. Not in other trial within 3 months prior to the start of this trial.
  4. Willing to participate in this trial and to give informed consent/assent before any procedures are performed in this trial.

Exclusion Criteria:

  1. History of, or evidence of current malignancy within the past 5 years.
  2. Severe functional impairment of vital organs.
  3. Abnormal karyotype.
  4. Coagulation disorders.
  5. Severe pelvic adhesions.
  6. Uncontrolled acute or chronic gynecologic inflammation.
  7. Congenital adrenal cortical hyperplasia.
  8. Cushing's syndrome.
  9. Thyroid dysfunction.
  10. Pituitary adenoma.
  11. Pituitary amenorrhea or Hypothalamic amenorrhea.
  12. Thrombophlebitis, venous thrombosis or artery thrombosis.
  13. History of Oophorocystectomy.
  14. Currently pregnant or breast-feeding.
  15. Currently receiving other treatment that might affect the efficacy and safety of stem cells.
  16. History of severe drug allergy.
  17. Active infection detected by chest X-ray/CT.
  18. HIV, TPAb positive.
  19. Mental illness.
  20. Currently participating in any other clinical trial that uses interventional drugs or examinations.
  21. Patients that are deemed, by the investigator, inappropriate to participate in this trial.
Contacts and Locations
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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): NCT02912104


Locations
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China, Shanghai
The International Peace Maternity and Child Health Hospital
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
International Peace Maternity and Child Health Hospital
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Investigators
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Principal Investigator: Dongmei Lai, M.D. The center of Laboratory, The international peace Maternity and child health Hospital,School of Medicine, Shanghai Jiaotong University, Shanghai,China,200030
More Information
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Publications of Results:

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Responsible Party: Dongmei Lai, Principal Investigator, International Peace Maternity and Child Health Hospital
ClinicalTrials.gov Identifier: NCT02912104    
Other Study ID Numbers: 20152236
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The public can require the data and protocol from clinicaltrials.gov posted by investigator
Supporting Materials: Study Protocol
Time Frame: 2 years
Access Criteria: public
URL: https://clinicaltrials.gov

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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 Dongmei Lai, International Peace Maternity and Child Health Hospital:
primary ovarian insufficiency
premature ovarian failure
Infertility
human amniotic epithelial cells transplantation
Additional relevant MeSH terms:
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Infertility
Primary Ovarian Insufficiency
Menopause, Premature
Ovarian Diseases
 Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases