Viewing Study NCT04243681



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Last Modification Date: 2024-10-26 @ 1:26 PM
Study NCT ID: NCT04243681
Status: COMPLETED
Last Update Posted: 2020-10-22
First Post: 2019-08-14

Brief Title: Combination of Autologous MSC and HSC Infusion in Patients With Decompensated Cirrhosis
Sponsor: Asian Institute of Gastroenterology India
Organization: Asian Institute of Gastroenterology India

Study Overview

Official Title: Combination of Autologous Mesenchymal and Hematopoietic Stem Cell Infusion in Patients With Decompensated Cirrhosis A Pilot Study
Status: COMPLETED
Status Verified Date: 2020-01
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: Though the results of autologous CD34 cell infusion and MSC in independent studies have shown promise yet they are yet to reach the desired long term outcome The possible postulation for this is possibly because when using autologous CD34 cell infusion the inflammatory milieu of the liver may not be conducive for sustained effects of the mobilized CD 34 cells MSC have immunomodulatory effect ref and may improve the liver environment making it more beneficial for the CD34 cells to function and survive In addition MSC has ben shown to produce hepatocyte growth factor which is protective against liver injury and beneficial for liver regeneration shown in above tables However it remains to be understood how MSCs promote liver stem stem cells to differentiate into hepatocytes or expand the residual hepatocyte population MSC can also directly inhibit the activation of hepatic stellate cells the main source of extracellular matrix via MSC derived IL 10 and TNF-αand may also induce hepatic stellate cell apoptosis Current lacunae in cell based therapy is based on the poor consensus and understanding on the best type of cells to be used the ideal number of cells the most appropriate route of administration and the need for repeat dosing The concept that combination of autologous hematopoietic and mesenchymal stem cells infusion may be more beneficial than infusing any one of them alone has been discussed in many scientific forums but there are no study till date to either see the safety as well as the efficacy of this proof of concept

With this above background data we propose a study design which will be a safety study for combination use of autologous CD34 and MSC
Detailed Description: None

Study Oversight

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