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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01378182 |
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Date of registration:
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20/06/2011 |
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Primary sponsor: |
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Public title:
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Efficacy of Invitro Expanded Bone Marrow Derived Allogeneic Mesenchymal Stem Cell Transplantation Via Portal Vein or Hepatic Artery or Peripheral Vein in Patients With Wilson Cirrhosis
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Scientific title:
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Efficacy of Invitro Expanded Bone Marrow Derived Allogeneic Mesenchymal Stem Cell Transplantation Via Portal Vein or Hepatic Artery or Peripheral Vein in Patients With Wilson Cirrhosis |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01378182 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Murat KANTARCIOGLU, MD |
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Address:
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Telephone:
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+90 532 5607207 |
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Email:
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kantarci@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical, radiologic and pathologically proven Wilson's Disease with hepatic
presentation
- 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:
- Clinical diagnosis of Wilson's Disease with neuropsychiatric presentation
- Current alcohol consumption
- Patients who have acute or chronic viral hepatitis infection
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Wilson's Disease
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Intervention(s)
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Genetic: allogeneic mesenchymal stem cell transplantation
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Primary Outcome(s)
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differantiation of transplanted mesenchymal stem cells to hepatocytes in post treatment liver biopsies
[Time Frame: liver biopsies performed at sixth month after mesenchymal stem cell transplantation]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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