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Premature Ovarian FailurePhase 1ADMSCNCT06132542

Autologous ADMSC Transplantation in Patients With POI

A Phase 1 study testing stem cell therapy in people with Premature Ovarian Failure, run by Mongolian National University of Medical Sciences at 1 site in Mongolia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary ovarian insufficiency (premature ovarian failure, premature ovarian insufficiency, premature menopause) is a hypergonadotropic hypogonadism, that failure of the ovarian function in woman younger than 40 years. Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Premature Ovarian Failure
What is being tested?
stem cell therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteMongolia
Study dates
15 Jan 2024to 15 Dec 2024
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 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Signed and dated informed consent.
  • Female over the age of 18
  • Diagnosis of premature ovarian insufficiency: At least two menopausal FSH levels (≥ 40 IU/L) and/or Primary or secondary amenorrhea at least for 3-6 months OR Diagnosis of low ovarian reserve defined as: AMH < _0.42 ng/ML \& FSH >20 IU/L, and/or failure of prior attempts of assisted reproductive techniques due to limited ovarian response (poor responder).
  • Presence of at least one ovary
  • Acceptable uterine anatomy (by any clinically and/or imaging acceptable methods)
  • Normal thyroid function as evidence by normal serum Thyroid Stimulating Hormone (TSH) levels.
  • Agree to report any pregnancy to the research staff immediately.
  • Willing and able to comply with study requirements and follow up instructions.

Who cannot join

  • Has a history of, or evidence of current gynecologic malignancy within the past three years
  • Presence of adnexal masses indicating the need for further evaluation
  • Major mental health disorder that precludes participation in the study
  • Active substance abuse or dependence
  • Current or recent (within the past 2 weeks) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, herbal or botanical supplements with possible hormonal effects. Washout will be allowed.
  • Type I or Type II diabetes mellitus, or if receiving antidiabetic medications
Show all 12Show fewer
  • Known significant anemia (Hemoglobin <8 g/dL).
  • Untreated deep venous thrombosis, and/or pulmonary embolus
  • Untreated cerebrovascular disease
  • Known heart disease (New York Heart Association Class II or higher).
  • Known Liver disease (defined as Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)>2 times normal, or total bilirubin >2.5 mg/dL).
  • Known Renal disease (defined as Blood urea nitrogen (BUN)>30 mg/dL or serum creatinine > 1.6 mg/dL).

Trial locations and contacts

1 site in 1 country.

Khongorzul Batchuluun, Ph.D contact

976-72116389

khongorzul.bat@mnums.edu.mn

Serjnyam Sukhbaatar, M.S contact

976-9008-8896

serjnyam@mnums.edu.mn

Mongolia1 site

  • Mongolian National University of Medical Science

    Ulaanbaatar

    Batsuren Choijamts, Ph.D, 976-72116389, batsuren.ch@mnums.edu.mn

    Serjnyam Sukhbaatar, M.S, 976-9008-8896, serjnyam@mnums.edu.mn

Other trials in Mongolia

About this study

Official title: Autologous Adipose Derived Mesenchymal Stromal Cell Transplantation in Patients With Idiopathic or Drug Induced Premature Ovarian Failure

The primary ovarian insufficiency (premature ovarian failure, premature ovarian insufficiency, premature menopause) is a hypergonadotropic hypogonadism, that failure of the ovarian function in woman younger than 40 years. Fat derived stem cells are mainly mesenchymal stem cells and found to be effective treatment in joint and bone regeneration.

We are planning to investigate the effectiveness of adipose stem cell on ovarian tissue regeneration for patients with premature ovarian failure.

Read the detailed description

The primary ovarian insufficiency (premature ovarian failure, premature ovarian insufficiency, premature menopause) is a hypergonadotropic hypogonadism, that failure of the ovarian function in woman younger than 40 years. Ovary is a important organ of reproduction as well as endocrine organ that secretes estrogen and progesterone to stimulate the endometrium and other organs. The main features of are sex hormone deficiency, amenorrhea, infertility, and elevated serum gonadotropins.

This condition occurs in approximately 1% of women and it has significant psychological and physical consequences in those patients.

The current management involves hormone replacement therapy and infertility treatment using egg donors.

Stem cells are the foundation cells for every organ, tissue, and cell in the body. They are undifferentiated cells that do not yet have specific function. Under proper conditions, they begin to develop into specialized tissue and organs. Fat derived stem cells are mainly mesenchymal stem cells and found to be effective treatment in joint and bone regeneration.

This study is an open-label investigation of the efficacy of injection of autologous adipose derived stem cells into the ovarian stroma of patients with premature ovarian failure. Totally 10 women with POI will be recruited in this study after the written informed consent. Diagnosis will be based mainly on history taking, physical examination, and laboratory investigations. Laboratory investigations will include serum follicle stimulating hormone (FSH), serum estrogen measurement and serum AMH. The typical FSH in POI patients is over 40mIU/ml (post-menopausal range). Subjects will be enrolled based on specific inclusion/exclusion criteria and will be evaluated at regular post-transplant intervals.

The fat derived stem cell will be transplanted by a reproductive gynecologist who does routine ovarian puncture. Subjects will be monitored frequently for a total of one year after ADSCs injection. For the safety of patients, the stem cell will be injected in one ovary only and the other ovary will be spared.

Sample of 150-250 ml aspirated from the fat will be processed according to the manufacturers guide and totally 5 million of ADSCs will be injected into the ovaries under guidance of transvaginal sonography. Endometrial fractional biopsy will be taken, stained with H\&E stain. Participants will be followed up monthly for a period of 6 months by hormonal (FSH, LH, E2, AMH), clinical (resuming menstruation), US (folliculometry).

Being tested
stem cell therapy
Medical subject headings
Primary Ovarian Insufficiency

What participants receive

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

  • stem cell therapyBiological

    Also called fat derived stem cell

    The fat derived stem cell will be transplanted by a reproductive gynecologist who does routine ovarian puncture.

Study groups in NCT06132542
Study groupRoleWhat they receive
ExperimentalExperimentalOpen label study
Receives: Biological: stem cell therapy

What is being measured

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

  1. Resumption of menses (12 months)

    regular 25-45 day cycle menses, with 2-5 day bleeding.

    Measured: 12 months

  2. Improved clinical hormone levels.

    FSH 4.7 to 21.5 mIU/mL (4.5 to 21.5 IU/L)

    Measured: 12 months

Secondary outcomes (1)

  1. Achievement of pregnancy

    A transvaginal ultrasound confirmation of gestational sac The hCG levels have reached between 1,000 - 2,000 mIU/mL.

    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 posted15 Nov 2023
  2. Study start15 Jan 2024 (estimated)
  3. Primary completion15 Oct 2024 (estimated)
  4. Study completion15 Dec 2024 (estimated)

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
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06132542
Sponsor's protocol ID
23/035
Acronym
ADMSC
Status last verified
Nov 2023
First submitted
7 Nov 2023
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Golezar S, Ramezani Tehrani F, Khazaei S, Ebadi A, Keshavarz Z. The global prevalence of primary ovarian insufficiency and early menopause: a meta-analysis. Climacteric. 2019 Aug;22(4):403-411. doi: 10.1080/13697137.2019.1574738. Epub 2019 Mar 4.

    PubMed 30829083

  • European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI; Webber L, Davies M, Anderson R, Bartlett J, Braat D, Cartwright B, Cifkova R, de Muinck Keizer-Schrama S, Hogervorst E, Janse F, Liao L, Vlaisavljevic V, Zillikens C, Vermeulen N. ESHRE Guideline: management of women with premature ovarian insufficiency. Hum Reprod. 2016 May;31(5):926-37. doi: 10.1093/humrep/dew027. Epub 2016 Mar 22.

    PubMed 27008889

  • Howard-Anderson J, Ganz PA, Bower JE, Stanton AL. Quality of life, fertility concerns, and behavioral health outcomes in younger breast cancer survivors: a systematic review. J Natl Cancer Inst. 2012 Mar 7;104(5):386-405. doi: 10.1093/jnci/djr541. Epub 2012 Jan 23.

    PubMed 22271773

  • Baber RJ, Panay N, Fenton A; IMS Writing Group. 2016 IMS Recommendations on women's midlife health and menopause hormone therapy. Climacteric. 2016 Apr;19(2):109-50. doi: 10.3109/13697137.2015.1129166. Epub 2016 Feb 12.

    PubMed 26872610

  • Anderson RA, Mansi J, Coleman RE, Adamson DJA, Leonard RCF. The utility of anti-Mullerian hormone in the diagnosis and prediction of loss of ovarian function following chemotherapy for early breast cancer. Eur J Cancer. 2017 Dec;87:58-64. doi: 10.1016/j.ejca.2017.10.001. Epub 2017 Nov 5.

    PubMed 29117576

  • Bidet M, Bachelot A, Bissauge E, Golmard JL, Gricourt S, Dulon J, Coussieu C, Badachi Y, Touraine P. Resumption of ovarian function and pregnancies in 358 patients with premature ovarian failure. J Clin Endocrinol Metab. 2011 Dec;96(12):3864-72. doi: 10.1210/jc.2011-1038. Epub 2011 Oct 12.

    PubMed 21994953

  • Sauer MV. Spontaneous pregnancy in women awaiting oocyte donation. J Reprod Med. 1995 Sep;40(9):630-2.

    PubMed 8576878

  • van Kasteren YM, Schoemaker J. Premature ovarian failure: a systematic review on therapeutic interventions to restore ovarian function and achieve pregnancy. Hum Reprod Update. 1999 Sep-Oct;5(5):483-92. doi: 10.1093/humupd/5.5.483.

    PubMed 10582785

  • Alatab S, Shekarchian S, Najafi I, Moghadasali R, Ahmadbeigi N, Pourmand MR, Bolurieh T, Jaroughi N, Pourmand G, Aghdami N. Systemic Infusion of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in Peritoneal Dialysis Patients: Feasibility and Safety. Cell J. 2019 Jan;20(4):483-495. doi: 10.22074/cellj.2019.5591. Epub 2018 Dec 12.

    PubMed 30123994

  • Mashayekhi M, Mirzadeh E, Chekini Z, Ahmadi F, Eftekhari-Yazdi P, Vesali S, Madani T, Aghdami N. Evaluation of safety, feasibility and efficacy of intra-ovarian transplantation of autologous adipose derived mesenchymal stromal cells in idiopathic premature ovarian failure patients: non-randomized clinical trial, phase I, first in human. J Ovarian Res. 2021 Jan 6;14(1):5. doi: 10.1186/s13048-020-00743-3.

    PubMed 33407794

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing stem cell therapy in people with Premature Ovarian Failure, run by Mongolian National University of Medical Sciences at 1 site in Mongolia.

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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 15 Nov 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 Mongolia. 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?

Results are not available in the source record.

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

Contact Khongorzul Batchuluun, Ph.D (976-72116389, khongorzul.bat@mnums.edu.mn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resumption of menses (12 months) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT06132542, which also lists 10 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 15 Nov 2023.

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