A Clinical Study to Evaluate the Safety and Efficacy of Mesenchymal Stem Cells in Liver Cirrhosis
NCT01877759 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2013-10-09
Summary
Cirrhosis is caused by sustained liver damage over several years either by alcohol, viral infection (Hepatitis B, C), a toxic substance (for eg. drugs, excess copper or iron in the liver), or by blockage of biliary system such that the liver undergoes progressive scarring that slowly replaces all of normal liver cells.(LC) represents a late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules. For this condition of disease the liver transplantation is one of the only effective therapies available ,but due to lack of donors, surgical complications, rejection, and high cost are it's serious problems.
Presently stem cells are used to be a one of the treatment for the same. So our approach is to evaluate the safety and efficacy of mesenchymal stem cell in condition of liver cirrhosis .
Conditions
Interventions
- BIOLOGICAL
-
Mesenchymal stem cell
Intravenous dose of Mesenchymal stem cell derived from human Bone Marrow \& umbilical cord , IN 6 divided doses , at interval of 1 week .
Sponsors & Collaborators
-
Chaitanya Hospital, Pune
lead OTHER
Principal Investigators
-
ANANT E BAGUL, MS ORTHO · Chaitanya Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 25 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-12-31
- Primary Completion
- 2014-12-31
- Completion
- 2014-12-31
Countries
- India
Study Locations
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