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A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Insufficiency Patients (POI)

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ClinicalTrials.gov Identifier: NCT02912104
Recruitment Status : Unknown
Verified September 2016 by Dongmei Lai, International Peace Maternity and Child Health Hospital.
Recruitment status was:  Recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Collaborator:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Information provided by (Responsible Party):
Dongmei Lai, International Peace Maternity and Child Health Hospital

Brief Summary:
This project will clarify the safety and effectiveness of human amniotic epithelial cells transplantation for the treatment of primary ovarian insufficiency(POI) 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:
Primary ovarian insufficiency(POI) 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 POI 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 POI disease which may offer a novel therapeutic strategy for improving the quality of life of POI patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Peace Maternity and Child Health Hospital (IPMCH) Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
Study Start Date : September 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Experimental: hAECs transplantation
To clarify the safety and effectiveness of human amniotic epithelial cells transplantation for the treatment of primary ovarian insufficiency(POI) patients
Biological: human amniotic epithelial cells (hAECs) transplantation
hAECs are prepared and cultured using GMP(Good Manufacturing Practice, GMP) rules, 2×107 hAEC in 5ml sample is separately injected into ovarian tissue by bilateral ovarian artery infusion.
Other Name: hAECs transplantation




Primary Outcome Measures :
  1. Hormonal Assessment serum FSH level will be measured. [ Time Frame: One year ]
    Participants were followed up every 8WKs and assessed by Hormonal Assessment

  2. Hormonal Assessment serum estrogen level will be measured. [ Time Frame: One year ]
    Participants were followed up every 8WKs and assessed by Hormonal Assessment

  3. Hormonal Assessment serum AMH level will be measured. [ Time Frame: One year ]
    Participants were followed up every 8WKs and assessed by Hormonal Assessment


Secondary Outcome Measures :
  1. Pregnancy rate will be measured. [ Time Frame: One year ]
    Participants were followed up every 8WKs and assessed by clinical assessment.Clinical Assessment includes Ultra Sound Assessment,Disappearance of Menopausal Symptoms, Pregnancy rate within 1 year of injection.



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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-menarche female less than 40 years old
  • Normal karyotyping female
  • Follicle-stimulating hormone (FSH) equal to 10-80 IU/L
  • Agree to sign the designed consent for the study

Exclusion Criteria:

  • Pregnancy and lactation
  • Female with abnormal karyotyping (e.g. turner syndrome, fragile X syndrome….)
  • Breast cancer, ovarian cancer
  • Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs
  • Those with major medical problems such as malignancy, hepatitis, etc.
  • Abnormal physical conditions

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


Contacts
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Contact: Dongmei Lai, M.D. 86-021-64070434 ext 27701 laidongmei@hotmail.com
Contact: Qian Wang, Ph.D 86-021-64070434 ext 27721 paulia@163.com

Locations
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China, Shanghai
The International Peace Maternity and Child Health Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Dongmei Lai, M.D    86-21-64070434-27701    laidongmei@hotmail.com   
Contact: Qian Wang, pH.D    86-21-64070434-27721    PAULIA@163.COM   
Sponsors and Collaborators
Dongmei Lai
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

Publications of Results:
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Responsible Party: Dongmei Lai, Principal Investigator, International Peace Maternity and Child Health Hospital
ClinicalTrials.gov Identifier: NCT02912104     History of Changes
Other Study ID Numbers: 20152236
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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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Primary Ovarian Insufficiency
Gonadal Dysgenesis
Ovarian Diseases
Urogenital Abnormalities
Congenital Abnormalities
Cardiovascular Abnormalities
Infertility
Menopause, Premature
Turner Syndrome
Genital Diseases, Male
Genital Diseases, Female
Adnexal Diseases
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