Polycystic Ovary Syndrome (PCOS)Phase 1NCT06143527
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for PCOS
A Phase 1 study testing Cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells in people with Polycystic Ovary Syndrome (PCOS) and Polycystic Ovary Syndrome, run by The Foundation for Orthopaedics and Regenerative Medicine at 2 sites in 2 countries.
Trial summary
This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome, PCOS
- What is being tested?
- Cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Nov 2023to 16 Nov 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ultrasound documented poly cystic ovary syndrome
Who cannot join
- 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
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- Continued drug abuse
- Previous organ transplant
- Hypersensitivity to sulfur
- Inability to supply proper informed consent
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Prodromos Stem Cell Institute
Naples, Florida, 34102
Chadwick Prodromos, MD, 847-699-6810 ext. 202, care@thepsci.com
Greece1 site, 1 recruiting
- Recruiting
Prodromos Stem Cell Institute
Athens
Chadwick Prodromos, MD, 847-699-6810 ext. 202, care@thepsci.com
About this study
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome
This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.
Read the detailed description
Stem cell treatment has shown efficacy for PCOS in both human and animal studies. Complete resolution was seen of polycystic ovary syndrome (PCOS) in a young woman after a single intravenous injection of umbilical cord or placental derived mesenchymal stem cells (MSC). It is hypothesized that intravenous infusion of MSC can reduce or eliminate PCOS. Hormone levels and ultrasound will be checked 3,6 and 12 months after treatment.
- Being tested
- Cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells
- Keywords
- Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome, PCOS, Stem Cell, Stem Cells, Mesenchymal Stem Cells, Umbilical Cord Derived Mesenchymal Stem Cells
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cellsBiological
Cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Intravenous infusion Receives: Biological: Cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Adverse Events
Clinical monitoring of possible adverse events or complications
Measured: Four year follow-up
Secondary outcomes (1)
Efficacy: Global Improvement Score (GI)
Ranging from 0 to 100%
Measured: Four year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start16 Nov 2023
- Primary completion16 Nov 2027 (estimated)
- Study completion16 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143527
- Sponsor's protocol ID
- 2023MSC-01
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No