A Proof of Concept Study to Evaluate Exosomes From Human Mesenchymal Stem Cells in Women With Premature Ovarian Insufficiency (POI)

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The VL-POI-01 study is designed to evaluate the safety and efficacy of human placental mesenchymal stem cell derived exosome treatment in patients with premature ovarian insufficiency (POI) and diminished ovarian reserve.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vitti Labs, LLC

Criteria

Inclusion Criteria:

• Able to understand and communicate in English language

• Female of age 18-43 years

• Diagnosis of premature ovarian insufficiency based on ESHRE Guidelines (i) oligo/amenorrhea for at least 4 months, and (ii) an elevated FSH level >25 IU/L on two occasions >4 weeks apart, or diagnosis of low ovarian reserve defined as: Basal FSH value >10 IU/L or failure of prior attempts of assisted reproductive techniques due to limited ovarian response (poor responders)

• Normal karyotype 46, XX, and no known history FMR1 premutation (fragile X syndrome)

• Baseline AMH levels ≤ 1.0 ng/mL

• Presence of at least one ovary

• Normal uterine anatomy (by any clinically and/or imaging acceptable methods)

• Normal thyroid function as evident by normal serum Thyroid Stimulating Hormone (TSH) levels

• For subjects who had contraception before, the duration of amenorrhea should be more than 3 months after discontinuation of the oral contraception pill (OCP) or more than 6 months after discontinuation of Depo Provera (or similar) therapies

• Agree to report any pregnancy to the research staff immediately

• Willing and able to comply with study requirements and follow up instructions

• Patient with known history of endometriosis or polycystic ovarian syndrome

• If subject is planning to pursue pregnancy: presence of at least unilateral tubal patency (with any clinically acceptable methods)

Exclusion Criteria:

• Currently pregnant or breast-feeding

• Has a history of, or evidence of current gynecologic malignancy, breast cancer or other estrogen responsive cancer or any other malignancy within the past five years

• Subjects with FMR1 premutation (fragile X syndrome), a BMP15 mutation or family history of a first degree relative with POI

• 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, progestin, oral contraceptives), Danazol, anticoagulants, herbal or botanical supplements with possible hormonal effects. Washout will be allowed (2 weeks from screening)

• Subjects under hormonal treatments including hormone replacement therapy (HRT) for osteoporosis, cardiovascular disease, or recalcitrant vasomotor symptomatology within 3 months from screening

• Subjects with a history of breast cancer or other estrogen responsive cancer within 5 years from screening

• Subjects with existing malignant neoplasm, under active management for malignant neoplasm or under active surveillance for malignant neoplasm within 5 years from screening

• Subjects with history of thromboembolic events such as pulmonary embolism, stroke, or ischemic heart disease

• Subjects with uncontrolled hypertension, kidney disease, liver disease, or polycystic ovary syndrome (PCOS) as defined below:

• Uncontrolled hypertension: Systolic BP ≥ 140 and/or Diastolic BP ≥90 in patients taking anti-hypertensive treatment

• Kidney Disease: an estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m^2 (Incase the result is above/below acceptable range, one repeat test is acceptable)

• Liver Disease: Serum aminotransferase (ALT or AST) levels > 2x ULN

• PCOS criteria: Oligo-anovulation (Irregular periods), antral follicle count (AFC) >12 measuring 2-9mm, hyperandrogenism (elevated testosterone and DHEA levels), clinical hirsutism

• Subjects with untreated endocrinopathies including Cushing's disease, thyroid disease, congenital adrenal hyperplasia and hyperprolactinemia

• Subjects with intra-uterine devices (IUDs)

• Subjects who are allergic to low-molecular-weight heparin sodium or human albumin

• Medical conditions that are contraindicated in pregnancy

• Type I or Type II diabetes mellitus, or if receiving antidiabetic medications within 3 months from screening

• Known anemia (Hemoglobin < 11 g/dL)

• History of deep venous thrombosis, and/or pulmonary embolus

• History of cerebrovascular disease

• History of contrast media allergy

• 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 >2.5mg/dL)

• Known Renal disease (defined as Blood urea nitrogen (BUN) >30 mg/dL or serum creatinine > 1.6 mg/dL)