Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis

Phase 2

Completed

• Conditions: Alcoholic Liver Cirrhosis

• Registration Number: NCT01591200
• Lead Sponsor: Stempeutics Research Pvt Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-15
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-03
• Study Start: 2012-06
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety	2 years	The type of adverse events, number of adverse events and proportion of patients with adverse events

Secondary Outcome Measures

Name	Time	Method
Liver function tests.	2 years	To assess the improvement in liver function
CT scan of abdomen.	2 years	To assess the improvement in liver structure
Change in MELD score	2 years	To assess the clinical improvement
Improvement in quality of life as assessed by SF 36 questionnaire	2 years	To assess the improvement in quality of life
Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA	6 Months	To assess the improvement in histopathology
Change in Child-Pugh score	2 years	To assess clinical improvement

Trial Locations

Locations (10)

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