Viewing Study NCT06143527



Ignite Creation Date: 2024-05-06 @ 7:49 PM
Last Modification Date: 2024-10-26 @ 3:14 PM
Study NCT ID: NCT06143527
Status: RECRUITING
Last Update Posted: 2023-11-22
First Post: 2023-11-16

Brief Title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS
Sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Organization: The Foundation for Orthopaedics and Regenerative Medicine

Study Overview

Official Title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome
Status: RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: Stem cell treatment has shown efficacy for PCOS in both human and animal studies We are also reporting completer resolution of polycystic ovary syndrome PCOS in a young woman after a single intravenous injection of umbilical cord derived mesenchymal stem cells UCDSC We 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 36 and 12 months after treatment

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None