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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

Tracking Information
First Submitted Date  ICMJE March 7, 2016
First Posted Date  ICMJE March 10, 2016
Last Update Posted Date June 7, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2016)
All cause mortality [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02705742 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cells Transplantation for Liver Cirrhosis Due to HCV Hepatitis
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Cirrhosis
Intervention  ICMJE 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)
Study Arms  ICMJE stem cells group
mesenchymal stem cells only
Intervention: Biological: Mesenchymal Stem Cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 9, 2016)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02705742
Other Study ID Numbers  ICMJE GMMA-HCV-MSC-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Study Sponsor  ICMJE Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Murat Kantarcioglu, M.D. Gulhane Military Medical Academy, Department of Gastroenterology
PRS Account Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP