Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis
NCT ID: NCT01591200
Last Updated: 2016-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2012-06-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
This arm will receive standard protocol of care alone
No interventions assigned to this group
Stem cells high dose
This arm will receive high dose of Allogeneic Mesenchymal Stem Cells
Allogeneic Mesenchymal Stem Cells
High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Stem cells intermediate dose
This arm will receive intermediate dose of Allogeneic Mesenchymal Stem Cells
Allogeneic Mesenchymal Stem Cells
Intermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Stem cells low dose
This arm will receive low dose of Allogeneic Mesenchymal Stem Cells
Allogeneic Mesenchymal Stem Cells
Low dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Interventions
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Allogeneic Mesenchymal Stem Cells
High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Allogeneic Mesenchymal Stem Cells
Intermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Allogeneic Mesenchymal Stem Cells
Low dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Eligibility Criteria
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Inclusion Criteria
* Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7 and \<14).
* MELD scores of at least 10 (UNOS Meld calculator).
* Normal AFP Level
* Hb\>10gm/dl.
* Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
* Signed informed consent.
Exclusion Criteria
* Presence of advanced hepatic encephalopathy Grades 3 \& 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening
* Active variceal bleed.
* Refractory ascites.
* Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.
* Platelet count \< 30,000/mm3.
* Serum Sodium \<129mEq/L.
* Serum Creatinine \> 2 mg/dl.
* Hepatocellular carcinoma or other malignancies
* Active infectious disease.
* Presence of severe underlying cardiac, pulmonary or renal disease.
* Excessive alcohol (\>30 gm of alcohol/day) use in the last 3 months before screening.
* Positive HbSAg or antibodies to HIV or HCV.
* Pregnancy or lactation.
* Participation in other clinical trials.
* Unwilling/unable to sign the informed consent.
18 Years
65 Years
ALL
No
Sponsors
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Stempeutics Research Pvt Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. BV Tantry, MD., DM
Role: PRINCIPAL_INVESTIGATOR
KMC, Mangalore
Dr. Samir Shah, MD., DM
Role: PRINCIPAL_INVESTIGATOR
Breach Candy Hospital, Mumbai
Dr. Dinesh Kini, MD., DM
Role: PRINCIPAL_INVESTIGATOR
Manipal Hospital, India
Dr.Deepak N Amarapuraka, MD., DM
Role: PRINCIPAL_INVESTIGATOR
Bombay Hospital & Medical Research Center, Mumbai
Dr. VA Saraswat, MD., DM
Role: PRINCIPAL_INVESTIGATOR
SGPGI, Kucknow
Dr. Aejaz Habeeb, MD., DM
Role: PRINCIPAL_INVESTIGATOR
Centre for Liver Research & Diagnostics, Hyderabad
Dr Uma Devi, MD
Role: PRINCIPAL_INVESTIGATOR
Mediciti Hospital
Dr Sanjay Kolte Kolte, DNB., FCPS
Role: PRINCIPAL_INVESTIGATOR
Sahyadri Speciality Hospital
Dr Sandeep Nijhwan Nijhwan, MD., DM
Role: PRINCIPAL_INVESTIGATOR
SMS Medical College and Hospital
Dr. Nitin Pai, MD., DM
Role: PRINCIPAL_INVESTIGATOR
Ruby Hall clinic
Locations
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Centre for Liver Research & Diagnostics
Hyderabad, Andhra Pradesh, India
Mediciti Hospital
Hyderabad, Andhra Pradesh, India
Manipal Hospital
Bangalore, Karnataka, India
KMC Hospital
Mangalore, Karnataka, India
Institute of liver disease, HPB surgery and transplant Global Hospitals
Mumbai, Maharashtra, India
Bombay Hospital & Medical Research Center
Mumbai, Maharashtra, India
Ruby Hall clinic
Pune, Maharashtra, India
Sahyadri Speciality Hospital
Pune, Maharashtra, India
SMS Medical college and Hospital
Jaipur, Rajasthan, India
SGPGI Lucknow
Lucknow, Uttar Pradesh, India
Countries
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Other Identifiers
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SRPL/LC/09-10/001
Identifier Type: -
Identifier Source: org_study_id
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