Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AlloRx.
- Who it may be relevant to
- Registry conditions: Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome, PCOS. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Antigua and Barbuda, Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome
Overview
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.
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 derived mesenchymal stem cells (UCDSC). It is hypothesized that intravenous infusion of UCDSC can reduce or eliminate PCOS. Patients will receive roughly 2 million umbilical cord derived mesenchymal stem cells per kg of body weight. Hormone levels and ultrasound will be checked 3,6 and 12 months after treatment.
Interventions
- Biological AlloRx
Cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Primary outcome measures
- Safety: Adverse Events [Time frame: Four year follow-up]
Secondary outcome measures (1)
- Efficacy: Global Improvement Score (GI) [Time frame: Four year follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Antigua and Barbuda · 1 center
- Medical Surgical Associates Center — St John's
Greece · 1 center
- Athens Beverly Hills Medical Group — Glyfada
Identifiers
NCT: NCT06143527 · 2023MSC-01