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