Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS (NCT06143527) | Clinical Trial Compass
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS
Antigua and Barbuda, Greece20 participantsStarted 2023-11-16
Plain-language summary
This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.
Who can participate
Age range
18 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:
• Ultrasound documented poly cystic ovary syndrome
Exclusion Criteria:
* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety
* Continued drug abuse
* Previous organ transplant
* Hypersensitivity to sulfur
* Inability to supply proper informed consent
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.
1Since this is a Phase 1 trial focused on safety rather than effectiveness, what does that mean for me in terms of what we actually know so far about whether stem cell treatment helps with PCOS symptoms?
2The stem cells in this trial come from someone else's umbilical cord tissue — what are the specific risks my doctor would want me to watch for if I were to consider a treatment like this?
3How does this experimental stem cell approach compare to the standard treatments I might try first for my PCOS, like hormonal therapy or lifestyle changes, and is it worth discussing those options before looking at a Phase 1 trial?
4Given that the main thing this trial is measuring is adverse events — meaning side effects and safety signals — what kinds of problems have been seen with mesenchymal stem cell treatments in other early-phase studies that I should ask the research team about?
5What would my doctor want to know about my current PCOS symptoms, medical history, or other treatments I've tried before they could even begin to evaluate whether discussing this trial with the research team makes sense for my situation?
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.
What they're measuring
1
Safety: Adverse Events
Timeframe: Four year follow-up
Trial details
NCT IDNCT06143527
SponsorThe Foundation for Orthopaedics and Regenerative Medicine