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Trial record 10 of 1238 for:    "North American Indian childhood cirrhosis" OR "Liver Cirrhosis"

Mesenchymal Stem Cells Transplantation for Liver Cirrhosis Due to HCV Hepatitis

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ClinicalTrials.gov Identifier: NCT02705742
Recruitment Status : Unknown
Verified June 2016 by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
Recruitment status was:  Recruiting
First Posted : March 10, 2016
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Brief Summary:
In this study, investigators aimed to transplant autologous, adipose tissue derived mesenchymal stem cells to the patients with liver cirrhosis due to HCV. We also aimed to assess liver tissue regeneration, downgrade of clinical findings and antiviral efficacy. Finally investigators aimed to establish an alternative treatment modality to liver transplantation.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Biological: Mesenchymal Stem Cells Phase 1 Phase 2

Detailed Description:

In this study, investigators aimed to transplant autologous, adipose tissue derived mesenchymal stem cells to the patients with liver cirrhosis. Investigators also aimed to assess liver tissue regeneration, downgrade of clinical findings and antiviral efficacy. Finally investigators aimed to establish an alternative treatment modality to liver transplantation.

Hepatitis C Virus (HCV) which can lead to chronic hepatitis, liver cirrhosis and hepatocellular carcinoma (HCC) is an important health problem especially in western countries. In 5% - 25 of patients with chronic HCV hepatitis who are nonresponders to current medical treatment, liver cirrhosis develops. Approximately 1/3 of patients with liver cirrhosis become decompensate in 10 years. Medical treatment of liver cirrhosis, the last stage of the illness that leads to morbidity and mortality is difficult. Liver transplantation is still the most effective treatment for the patients with liver cirrhosis due to chronic hepatitis C, However, serious problems are accompanied with liver transplantation. Lack of liver donors, complications during and after the surgery, graft rejection and high costs are the main problems.

There are cells in the human body that are capable to renew themselves and differentiate to a diverse range of specialized cell types. These are called "stem cells". Stem cells can be differentiated to specialized cells in appropriate medias in the laboratory. Recently, the differentiation potential of mesenchymal stem cells (MSCs) into hepatocytes is proved by demonstrating hepatocytes containing Y chromosome in the female who has had bone marrow transplantation from male donors. In many laboratory studies, it is observed that human adipose tissue derived mesenchymal stem cells, transplanted to animals with induced liver damage, differentiate into the albumin producing hepatocytes. Even though the number of studies on human for the same purpose is few, findings are supporting those of animal experiments. Some very recent studies emphasize the antiviral effects of MSCs. The reasons for choosing this study title is; no available medical treatment for the non-responder cirrhotic patients, shortage of organ donors, patients rapidly progressing to transplantation candidates, and patients dying while they are in waiting lists and finally hopeful data regarding MSC applications. This is a hopeful, avant garde and sophisticated study which may constitute new horizons in context of cellular therapies.

In this study autologous adipose tissue derived MSCs will be transplanted to patients with liver cirrhosis due to chronic hepatitis C. After invitro expansion, patients will receive 1 million cells per kg. via peripheral vein every week for 3 times. Also via hepatic artery, 3 million cells per kg will be infused for 3 times in every 2 weeks. With this protocol, investigators aimed to increase liver regeneration, decrease in liver fibrosis, increase the waiting time of patients in transplantation lists and finally to establish a new and regenerative treatment protocol alternative to liver transplantation. For observation of clinical and laboratory improvement, patients are planned to be monitored by pathology examination of liver biopsies before and at 6th month after the treatment, monthly biochemical and hematologic blood tests and periodic radiologic examinations.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Adipose Tissue Derived Autologous Repeated Mesenchymal Stem Cells Transplantation Via Hepatic Artery and Peripheral Vein in Patients With Liver Cirrhosis Due to HCV Hepatitis
Study Start Date : January 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis Hepatitis

Arm Intervention/treatment
stem cells group
mesenchymal stem cells only
Biological: Mesenchymal Stem Cells
1.000.000 (one million) cells/kg, IV of dose in the Peripheral vein and 3.000.000 (three million) cells/kg of dose into the right hepatic artery)




Primary Outcome Measures :
  1. All cause mortality [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical, radiologic and pathologically proven Liver Cirrhosis Due to HCV Hepatitis
  • Patients with no hepatic malignancies
  • No co-existing serious respiratory and/or cardiovascular morbidities
  • Patients who approved to join the study group with informed and written consent
  • Patients with platelet count more than 30.000/mm3

Exclusion Criteria:

  • Current alcohol consumption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705742


Contacts
Contact: Hakan Demirci, M.D. 00905325140028 hakandemircigata@yahoo.com

Locations
Turkey
Gulhane Military Medical Academy Recruiting
Ankara, Turkey, 06010
Contact: Hakan Demirci, M.D.    00905325140028    hakandemircigata@yahoo.com   
Sponsors and Collaborators
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Investigators
Study Chair: Murat Kantarcioglu, M.D. Gulhane Military Medical Academy, Department of Gastroenterology

Publications of Results:
Responsible Party: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
ClinicalTrials.gov Identifier: NCT02705742     History of Changes
Other Study ID Numbers: GMMA-HCV-MSC-1
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi:
Mesenchymal stem cells
Liver cirrhosis
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Fibrosis
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Pathologic Processes