Autologous ADMSC Transplantation in Patients With POI

Launched by MONGOLIAN NATIONAL UNIVERSITY OF MEDICAL SCIENCES · Nov 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for women with premature ovarian failure (POI), a condition where the ovaries stop functioning before the age of 40. The researchers want to see if using stem cells from fat tissue can help regenerate ovarian function and improve symptoms associated with POI. This is a Phase 1 trial, which means they are in the early stages of testing this treatment for safety and effectiveness.

To be eligible for this trial, participants must be women over 18 who have been diagnosed with POI and have at least one functioning ovary. They also need to have normal thyroid function and agree to report any pregnancies during the study. However, certain conditions, like current cancer, major mental health issues, or severe heart or liver disease, would exclude someone from participating. If you take part, you can expect to receive treatment and follow-up care, with close monitoring by the research team throughout the study. This trial is not yet recruiting participants, but it aims to offer hope for women facing the challenges of premature ovarian failure.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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).