AzTrials
AzTrials

Primary Ovarian InsufficiencyPhase 1POFNCT02912104

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

A Phase 1 study testing human amniotic epithelial cells (hAECs) transplantation in people with Primary Ovarian Insufficiency and Premature Ovarian Failure, run by International Peace Maternity and Child Health Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
human amniotic epithelial cells (hAECs) transplantation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
20 Jun 2020to 5 Jan 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • ≥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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The International Peace Maternity and Child Health Hospital

    Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

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.

Read the 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.

Being tested
human amniotic epithelial cells (hAECs) transplantation
Keywords
primary ovarian insufficiency, premature ovarian failure, Infertility, human amniotic epithelial cells transplantation
Medical subject headings
Primary Ovarian Insufficiency, Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • human amniotic epithelial cells (hAECs) transplantationBiological

    Also called 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.

Study groups in NCT02912104
Study groupRoleWhat they receive
hAECs transplantationExperimentalTo clarify the safety and effectiveness of human amniotic epithelial cells transplantation for the treatment of POF patients
Receives: Biological: human amniotic epithelial cells (hAECs) transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability assessed by Adverse Events

    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)

    Measured: 150 days

Secondary outcomes (8)

  1. Change from baseline in bilateral ovarian volume

    The ovarian volume will be assessed by pelvic ultrasound on 30th, 90th, 150th days after transplantation.

    Measured: 150 days

  2. Change from baseline in number of antral follicles (AFC)

    The number of antral follicles developing will be assessed by pelvic ultrasound on 30th, 90th, 150th days after transplantation.

    Measured: 150 days

  3. Change from baseline in Follicle-stimulating hormone (FSH) serum level

    Serum FSH level will be tested on 30th and 150th days after transplantation.

    Measured: 150 days

  4. Change from baseline in Luteinizing hormone (LH), Estradiol (E2), Testosterone (T), Prolactin (PRL) , Anti-müllerian hormone (AMH) serum level

    Serum LH, E2, T, PRL, AMH level will be tested on 30th and 150th days after transplantation.

    Measured: 150 days

  5. Menstruation resumption

    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.

    Measured: 150 days

  6. Endometrial thickness

    The endometrial thickness will be assessed by pelvic ultrasound on 30th, 90th, 150th days after transplantation.

    Measured: 150 days

  7. Bone mineral density (BMD) measurements

    The BMD will be tested on 150th day after transplantation.

    Measured: 150 days

  8. Achievement of pregnancy

    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.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2016 (estimated)
  2. Study start20 Jun 2020
  3. Primary completion5 Jan 2022
  4. Study completion5 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02912104
Sponsor's protocol ID
20152236
Acronym
POF
Status last verified
Feb 2023
First submitted
6 Sep 2016
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The public can require the data and protocol from clinicaltrials.gov posted by investigator

Publications

  • Wang F, Wang L, Yao X, Lai D, Guo L. Human amniotic epithelial cells can differentiate into granulosa cells and restore folliculogenesis in a mouse model of chemotherapy-induced premature ovarian failure. Stem Cell Res Ther. 2013 Oct 14;4(5):124. doi: 10.1186/scrt335.

    PubMed 24406076

  • Zhang Q, Xu M, Yao X, Li T, Wang Q, Lai D. Human amniotic epithelial cells inhibit granulosa cell apoptosis induced by chemotherapy and restore the fertility. Stem Cell Res Ther. 2015 Aug 25;6(1):152. doi: 10.1186/s13287-015-0148-4.

    PubMed 26303743

  • Yao X, Guo Y, Wang Q, Xu M, Zhang Q, Li T, Lai D. The Paracrine Effect of Transplanted Human Amniotic Epithelial Cells on Ovarian Function Improvement in a Mouse Model of Chemotherapy-Induced Primary Ovarian Insufficiency. Stem Cells Int. 2016;2016:4148923. doi: 10.1155/2016/4148923. Epub 2015 Nov 9.

    PubMed 26664408

  • Weng L, Wei L, Zhang Q, Sun T, Kuang X, Huang Q, Cao Y, Liu X, Wang Q, Guo Y, Sun J, Wang L, Tang H, Yang H, Chen Q, Zhang J, Wang B, Qian Z, Lai D. Safety and efficacy of allogenic human amniotic epithelial cells transplantation via ovarian artery in patients with premature ovarian failure: a single-arm, phase 1 clinical trial. EClinicalMedicine. 2024 Jul 30;74:102744. doi: 10.1016/j.eclinm.2024.102744. eCollection 2024 Aug.

    PubMed 39165278

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing human amniotic epithelial cells (hAECs) transplantation in people with Primary Ovarian Insufficiency and Premature Ovarian Failure, run by International Peace Maternity and Child Health Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability assessed by Adverse Events (time frame: 150 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02912104, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in