Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476060
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2007-05-16
Brief Title:
Mesenchymal Stem Cell Transplantation in Decompensated Cirrhosis
Sponsor:
University of Tehran
Organization:
University of Tehran
Study Overview
Official Title:
Autologous Mesenchymal Stem Cell Transplantation in Patients With Decompensated Cirrhosis A Randomized Placebo-controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-05
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:
The standard treatment for decompensated cirrhosis is liver transplantation however it has several limitations Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis The investigators have already completed the phase 1 study of bone marrow mesenchymal stem cell MSC transplantation in 4 patients with cirrhosis The procedure was safe and feasible and led to somewhat promising results Mohamadnejad M et al 2006 Submitted for publication The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter randomized placebo-controlled trial in 50 patients with decompensated cirrhosis
Detailed Description:
The standard treatment for decompensated cirrhosis is liver transplantation however it has several limitations including small donor pool long waiting list and several complications Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis The investigators have already completed the phase 1 study of bone marrow mesenchymal stem cell MSC transplantation in 4 patients with cirrhosis The procedure was safe and feasible and led to somewhat promising results Mohamadnejad M et al 2006 Submitted for publication The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter randomized placebo controlled trial After assignment of the written informed consent thirty six patients with decompensated cirrhosis will be enrolled and will be randomized by block randomization into treatment or placebo arm All the enrolled patients will be in the waiting list of liver transplantation In the treatment arm bone marrow of the patients will be aspirated and autologous bone marrow mesenchymal stem cells will be cultured and then will be infused through a peripheral vein Also the corresponding placebo will be infused for the placebo group The patients will be followed up for 1 year after performing the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None