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 range
18 Years – 43 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.