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Clinical Study on the Safety and Efficacy of Human Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

ConditionPremature Ovarian Insufficiency
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorYan Hongli

About this trial

There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of human Amniotic mesenchymal stem cells (hA-MSCs) therapy in women suffering from POI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The intention of pregnant women aged >= 20 and < 40, with normal karyotype;

Oligo/amenorrhea for at least 4 months;

Elevated FSH level >25 IU/l on two occasions >4 weeks apart;

Without a history of stem cell therapy and no growth hormone and/or estrogen and progesterone therapy within the previous 3 months;

Disqualifiers

Unable to follow the treatment observation process required by the trial;

Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency/premature ovarian failure;

With breast, uterine, ovarian tumors, or any other benign or malignant tumors;

Allergic history to drugs or any other things;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Climen 21 Tablets

    Drug

    Climen is commonly used clinically as a hormone replacement therapy and was administered to all patients in both the control and experimental groups in this project.

  • hA-MSCs

    Biological/Vaccine

    The patients who were part of the experimental group were administered oral Clomid medication in conjunction with a combined intravenous injection of human amniotic MSCs.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: ClimenActive comparator 1 intervention
Group B: hA-MSCs+ClimenExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Temperature

Body temperature of the participants will be measured fortnightly after injection.

Time frame
Up to 24 weeks
2

Pulse

Pulse of the participants will be measured fortnightly after injection.

Time frame
up to 24 weeks
3

Breaths per minute

Breathing rate of the participants will be measured fortnightly after injection.

Time frame
up to 24 weeks
4

Blood pressure

Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.

Time frame
0-24 weeks

Secondary outcomes

1

Follicle-stimulating hormone (FSH) serum level

Serum FSH level will be tested fortnightly after injection.

Time frame
Up to 24 weeks
2

Estradiol (E2) serum level

Serum E2 level will be tested fortnightly after injection.

Time frame
Up to 24 weeks
3

Anti-Mullerian hormone (AMH) serum level

Serum AMH level will be tested fortnightly after injection.

Time frame
up to 24 weeks
4

Number of antral follicle

The number of antral follicles developing will be recorded by transvaginal ultrasound fortnightly after injection.

Time frame
up to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yan Hongli

Lead sponsor

Changhai Hospital

Sponsor institution

Source ClinicalTrials.gov
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