Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis
- Conditions
- Alcoholic Liver Cirrhosis
- Interventions
- Biological: Allogeneic Mesenchymal Stem Cells
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
- Arm && Interventions
Group Intervention Description Stem cells high dose Allogeneic Mesenchymal Stem Cells This arm will receive high dose of Allogeneic Mesenchymal Stem Cells Stem cells low dose Allogeneic Mesenchymal Stem Cells This arm will receive low dose of Allogeneic Mesenchymal Stem Cells Stem cells intermediate dose Allogeneic Mesenchymal Stem Cells This arm will receive intermediate dose of Allogeneic Mesenchymal Stem Cells
- 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)
Bombay Hospital & Medical Research Center
🇮🇳Mumbai, Maharashtra, India
Manipal Hospital
🇮🇳Bangalore, Karnataka, India
SMS Medical college and Hospital
🇮🇳Jaipur, Rajasthan, India
Centre for Liver Research & Diagnostics
🇮🇳Hyderabad, Andhra Pradesh, India
KMC Hospital
🇮🇳Mangalore, Karnataka, India
Institute of liver disease, HPB surgery and transplant Global Hospitals
🇮🇳Mumbai, Maharashtra, India
SGPGI Lucknow
🇮🇳Lucknow, Uttar Pradesh, India
Mediciti Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Sahyadri Speciality Hospital
🇮🇳Pune, Maharashtra, India
Ruby Hall clinic
🇮🇳Pune, Maharashtra, India