A Proof of Concept Study to Evaluate Exosomes From Human Mesenchymal Stem Cells in Women With Pre… (NCT06072794) | Clinical Trial Compass
SuspendedPhase 1
A Proof of Concept Study to Evaluate Exosomes From Human Mesenchymal Stem Cells in Women With Premature Ovarian Insufficiency (POI)
Stopped: Sponsor request
United States9 participantsStarted 2023-10-06
Plain-language 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.
Who can participate
Age range18 Years – 43 Years
SexFEMALE
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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 evid…