Stem Cell-Derived Exosomes for Diminished Ovarian Reserve
(VL-POI-01 Trial)
Trial Summary
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. If you are currently using oral or systemic corticosteroids, hormones, or certain other medications, you must stop them at least 2 weeks before the trial. Hormonal treatments for osteoporosis or other conditions must be stopped 3 months before the trial.
What data supports the effectiveness of the treatment EV-Pure™ for diminished ovarian reserve?
Research shows that exosomes (tiny particles released by cells) from stem cells can improve ovarian function in conditions similar to diminished ovarian reserve, like primary ovarian insufficiency. These exosomes have been shown to help restore ovarian function in animal studies by carrying specific molecules that promote cell growth and reduce damage.12345
Is the treatment using stem cell-derived exosomes generally safe for humans?
How is the treatment EV-Pure™ different from other treatments for diminished ovarian reserve?
EV-Pure™ is unique because it uses exosomes (tiny particles that carry signals between cells) derived from stem cells to potentially restore ovarian function. This approach is novel compared to traditional treatments, as it focuses on regenerative medicine to improve ovarian health, rather than just managing symptoms.12567
What is the purpose of this trial?
This trial is testing a new treatment using tiny particles from placental cells to help women with premature ovarian insufficiency. These particles help cells in the ovaries repair themselves and work better. The goal is to improve hormone production, egg development, and overall quality of life for these women. These particles have shown promise in treating various conditions by aiding in cell repair.
Eligibility Criteria
Women aged 18-43 with premature ovarian insufficiency (POI) or diminished ovarian reserve, not currently pregnant or breastfeeding, without recent cancer history. Must have normal chromosomes and thyroid function, no severe allergies to certain medications, and be willing to report pregnancies and follow study protocols.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous injection of VL-PX10 to restore steroidogenesis, folliculogenesis, and support quality of life improvement
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- EV-Pure™
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vitti Labs, LLC
Lead Sponsor