Autologous ADMSC Transplantation in Patients With POI

NCT06132542 | Unknown Phase 1 DMC

• 1 other identifier: 23/035
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Premature Ovarian Failure

Outcome Measures

Primary Outcomes (2)

• Resumption of menses (12 months)

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

  12 months

• Improved clinical hormone levels.

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

  12 months

Secondary Outcomes (1)

• Achievement of pregnancy

  12 months

Study Arms (1)

Experimental

EXPERIMENTAL

Open label study

Biological: stem cell therapy

Interventions

stem cell therapy BIOLOGICAL

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

Also known as: fat derived stem cell

Experimental

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Mongolian National University of Medical Sciences: lead

Study Sites (1)

Mongolian National University of Medical Science

Ulaanbaatar, Mongolia

Location

Related Publications (10)

• 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.

  PMID: 30829083 RESULT

• 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.

  PMID: 27008889 RESULT

• 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.

  PMID: 22271773 RESULT

• 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.

  PMID: 26872610 RESULT

• 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.

  PMID: 29117576 RESULT

• 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.

  PMID: 21994953 RESULT

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

  PMID: 8576878 RESULT

• 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.

  PMID: 10582785 RESULT

• 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.

  PMID: 30123994 RESULT

• 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.

  PMID: 33407794 RESULT

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Batsuren Choijamts, Ph.D

  Mnums

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khongorzul Batchuluun, Ph.D

CONTACT

976-72116389; khongorzul.bat@mnums.edu.mn

Serjnyam Sukhbaatar, M.S

CONTACT

976-9008-8896; serjnyam@mnums.edu.mn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 15, 2023
• Study Start: January 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: December 15, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)