Clinical trial
A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Failure
Name
20152236
Description
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.
Trial arms
Trial start
2020-06-20
Estimated PCD
2022-01-05
Trial end
2023-01-05
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
hAECs transplantation
Other names:
hAECs transplantation
Size
36
Primary endpoint
Safety and Tolerability assessed by Adverse Events
150 days
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}
Updated at
2023-03-01
1 organization
1 product
3 indications
Indication
Primary Ovarian InsufficiencyIndication
Premature Ovarian FailureIndication
infertility