Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05871463
Status:
RECRUITING
Last Update Posted:
2023-05-23
First Post:
2023-04-07
Brief Title:
Effect of Mesenchymal Stem Cells-derived Exosomes in Decompensated Liver Cirrhosis
Sponsor:
Research Institute for Gastroenterology and Liver Diseases RIGLD
Organization:
Research Institute for Gastroenterology and Liver Diseases RIGLD
Study Overview
Official Title:
Clinical Trial Phase IIa on Amelioration of Decompensated Liver Cirrhosis With Mesenchymal Stem Cells-derived Exosomes
Status:
RECRUITING
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:
Decompensated liver cirrhosis LC a life-threatening complication of chronic liver disease is one of the major indications for liver transplantation Recently mesenchymal stem cell MSC transfusion has been shown to lead to the regression of liver fibrosis in mice and humans However little is known about MSC-exosome therapy We will evaluate the therapeutic potential of mesenchymal stem Cell-Exosomes as an alternative to cell therapy in Cirrhotic patients This study examined the safety and efficacy of umbilical cord-derived MSC-exosomes in patients with decompensated LC
Detailed Description:
Liver fibrosis is the major cause of morbidity and mortality in patients with liver disorders Liver fibrosis can be reverted with the removal of the underlying etiology However if chronic inflammation and injury persist liver fibrosis is likely to progress to liver cirrhosis LC LC is generally characterized by the formation and accumulation of an extracellular matrix which lead to the progressive distortion of the hepatic architecture LC usually progresses irreversibly into a decompensated stage which is characterized by a series of clinical manifestations including ascites variceal hemorrhage and hepatic encephalopathy while ascites is the most common clinical symptom in such patients Although ascites might be treated with diuretics periodic paracentesis or a transjugular intrahepatic portosystemic shunt liver transplantation is the only option that can improve the survival of these patients However the severe shortage of donor livers high costs and potential serious complications have restricted the availability of liver transplantation worldwide Therefore alternative strategies are under intense investigation Mesenchymal stem cells MSC have self-renewal abilities and multidirectional differentiation potentials They also interact with various types of immune cells leading to immunomodulation MSCs have been used therapeutically in clinical trials for graft-versus-host disease and appear to be effective in immune-mediated tissue injury transplantation and autoimmunity In particular MSCs have also been used to treat liver diseases in animal models and patients Studies from animal models have shown that bone marrow-derived MSC BM-MSC infusion ameliorates liver fibrosis and reverses fulminant hepatic failure In clinical trials autologous MSC infusion has been demonstrated to be safe feasible and can improve the liver function of some LC patients In addition BM-MSC from patients with chronic HBV infection suffer from proliferative deficiency and might not be the best choice In contrast human umbilical cord-derived MSC UC-MSC are free from these limitations related to autologous BM-MSC In addition UC-MSC can be obtained from the discarded UC and therefore can be produced on a large scale It has been reported that human UC-MSC infusion can improve liver fibrosis in rats It has been shown that UC-MSC have potential to be used in clinical scenarios for the treatment of human liver diseases In the present study the investigators examine the safety and efficacy of UC-MSC derived exosomes in decompensated LC patients 15 enrolled patients will receive standard medication plus MSC-derived exosomes at a final dose of 40mg in three weeks
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