Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis - Full Text View

Purpose

This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.

Condition	Intervention	Phase
Alcoholic Liver Cirrhosis	Other: Standard protocol of care Biological: Allogeneic Mesenchymal Stem Cells	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Parallel Group Randomized Open Blinded End Point Evaluation, Multicentric, Dose Escalation, Phase -II Study Assessing the Safety and Efficacy of Intraarterial (Hepatic) Ex-vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Alcoholic Liver Cirrhosis

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Further study details as provided by Stempeutics Research Pvt Ltd:

Primary Outcome Measures:

Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
The type of adverse events, number of adverse events and proportion of patients with adverse events

Secondary Outcome Measures:

Liver function tests. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the improvement in liver function
CT scan of abdomen. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the improvement in liver structure
Change in MELD score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the clinical improvement
Improvement in quality of life as assessed by SF 36 questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the improvement in quality of life
Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
To assess the improvement in histopathology
Change in Child-Pugh score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess clinical improvement

Estimated Enrollment:	60
Study Start Date:	June 2012
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Control This arm will receive standard protocol of care alone	Other: Standard protocol of care Standard protocol of care for alcoholic liver cirrhosis will be given. No stem cells or placebo will be administered.
Experimental: Stem cells high dose This arm will receive high dose of stem cells	Biological: Allogeneic Mesenchymal Stem Cells High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Experimental: Stem cells intermediate dose This arm will receive intermediate dose of stem cells	Biological: Allogeneic Mesenchymal Stem Cells Intermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Experimental: Stem cells low dose This arm will receive low dose of stem cells	Biological: Allogeneic Mesenchymal Stem Cells Low dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological [CT scan] or histological evidence of cirrhosis and portal hypertension).
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:

Patients likely to undergo liver transplantation during the duration of the study.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591200

Contacts

Contact: Pawan K Gupta, MD.,DNB.,PhD	91-80-39992405	pawan.kumarg@manipal.edu
Contact: Anoop CH, MD	91-80-39992441	anoop.ch@stempeutics.com

Locations

India
Centre for Liver Research & Diagnostics	Not yet recruiting
Hyderabad, Andhra Pradesh, India, 500058
Contact: Dr. Aejaz Habeeb, MD., DM +91-40-24342954 aejazhabeeb@hotmail.com
Principal Investigator: Dr. Aejaz Habeeb, MD., DM
Manipal Hospital	Recruiting
Bangalore, Karnataka, India, 560017
Contact: Dr. Dinesh Kini, MD., DM 080-250243259 kini_gastro@hotmail.com
Principal Investigator: Dr. Dinesh Kini, MD., DM
KMC Hospital	Recruiting
Mangalore, Karnataka, India, 575001
Contact: Dr. BV Tantry, MD., DM 0824-2444590 tantrybv@gmail.com
Principal Investigator: Dr. BV Tantry, MD., DM
Breach Candy Hospital	Not yet recruiting
Mumbai, Maharashtra, India, 400026
Contact: Dr. Samir Shah, MD., DM 020-23535591 drshahsamir@gmail.com
Principal Investigator: Dr. Samir Shah, MD., DM
Bombay Hospital & Medical Research Center	Not yet recruiting
Mumbai, Maharashtra, India, 400020
Contact: Dr Deepak N Amarapurkar, MD., DM 91-022-22067676 amarapurkar@gmail.com
Principal Investigator: Dr Deepak N Amarapurkar, MD., DM
SGPGI Lucknow	Not yet recruiting
Lucknow, Uttar Pradesh, India, 226014
Contact: Dr. VA Saraswat, MD., DM 91-0522-2494407 profviveksaraswat@gmail.com
Principal Investigator: Dr. VA Saraswat, MD., DM

Sponsors and Collaborators

Stempeutics Research Pvt Ltd

Investigators

Principal Investigator:	Dr. BV Tantry, MD., DM	KMC, Mangalore
Principal Investigator:	Dr. Samir Shah, MD., DM	Breach Candy Hospital, Mumbai
Principal Investigator:	Dr. Dinesh Kini, MD., DM	Manipal Hospital, Bangalore
Principal Investigator:	Dr.Deepak N Amarapuraka, MD., DM	Bombay Hospital & Medical Research Center, Mumbai
Principal Investigator:	Dr. VA Saraswat, MD., DM	SGPGI, Kucknow
Principal Investigator:	Dr. Aejaz Habeeb, MD., DM	Centre for Liver Research & Diagnostics, Hyderabad

More Information

No publications provided

Responsible Party:	Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier:	NCT01591200 History of Changes
Other Study ID Numbers:	SRPL/LC/09-10/001
Study First Received:	April 15, 2012
Last Updated:	July 12, 2012
Health Authority:	India: Drugs Controller General of India

Keywords provided by Stempeutics Research Pvt Ltd:

Alcoholic
Liver
Cirrhosis
Stem
Cells

Additional relevant MeSH terms:

Liver Cirrhosis
Fibrosis
Liver Cirrhosis, Alcoholic
Liver Diseases
Digestive System Diseases

Pathologic Processes
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on June 17, 2013