A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Failure (POF)
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|ClinicalTrials.gov Identifier: NCT02912104|
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : March 1, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Primary Ovarian Insufficiency Premature Ovarian Failure Infertility||Biological: human amniotic epithelial cells (hAECs) transplantation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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)
- 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.
- 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.
- 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.
- 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.
- 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.
- Endometrial thickness [ Time Frame: 150 days ]The endometrial thickness will be assessed by pelvic ultrasound on 30th, 90th, 150th days after transplantation.
- Bone mineral density (BMD) measurements [ Time Frame: 150 days ]The BMD will be tested on 150th day after transplantation.
- 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.
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|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- ≥18 and<45 years old.
- 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.
- Not in other trial within 3 months prior to the start of this trial.
- Willing to participate in this trial and to give informed consent/assent before any procedures are performed in this trial.
- History of, or evidence of current malignancy within the past 5 years.
- Severe functional impairment of vital organs.
- Abnormal karyotype.
- Coagulation disorders.
- Severe pelvic adhesions.
- Uncontrolled acute or chronic gynecologic inflammation.
- Congenital adrenal cortical hyperplasia.
- Cushing's syndrome.
- Thyroid dysfunction.
- Pituitary adenoma.
- Pituitary amenorrhea or Hypothalamic amenorrhea.
- Thrombophlebitis, venous thrombosis or artery thrombosis.
- History of Oophorocystectomy.
- Currently pregnant or breast-feeding.
- Currently receiving other treatment that might affect the efficacy and safety of stem cells.
- History of severe drug allergy.
- Active infection detected by chest X-ray/CT.
- HIV, TPAb positive.
- Mental illness.
- Currently participating in any other clinical trial that uses interventional drugs or examinations.
- Patients that are deemed, by the investigator, inappropriate to participate in this trial.
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
|The International Peace Maternity and Child Health Hospital|
|Shanghai, Shanghai, China, 200030|
|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|
|Responsible Party:||Dongmei Lai, Principal Investigator, International Peace Maternity and Child Health Hospital|
|Other Study ID Numbers:||
|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|
|Time Frame:||2 years|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
primary ovarian insufficiency
premature ovarian failure
human amniotic epithelial cells transplantation
Primary Ovarian Insufficiency
Endocrine System Diseases