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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier:
NCT01591200
First received: April 15, 2012
Last updated: September 14, 2016
Last verified: September 2016
  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
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:


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


Enrollment: 40
Study Start Date: June 2012
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
This arm will receive standard protocol of care alone
Experimental: Stem cells high dose
This arm will receive high dose of Allogeneic Mesenchymal 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 Allogeneic Mesenchymal 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 Allogeneic Mesenchymal 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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
India
Centre for Liver Research & Diagnostics
Hyderabad, Andhra Pradesh, India, 500058
Mediciti Hospital
Hyderabad, Andhra Pradesh, India, 500063
Manipal Hospital
Bangalore, Karnataka, India, 560017
KMC Hospital
Mangalore, Karnataka, India, 575001
Institute of liver disease, HPB surgery and transplant Global Hospitals
Mumbai, Maharashtra, India, 400012
Bombay Hospital & Medical Research Center
Mumbai, Maharashtra, India, 400020
Ruby Hall clinic
Pune, Maharashtra, India, 411001
Sahyadri Speciality Hospital
Pune, Maharashtra, India, 411004
SMS Medical college and Hospital
Jaipur, Rajasthan, India, 302004
SGPGI Lucknow
Lucknow, Uttar Pradesh, India, 226014
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, India
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
Principal Investigator: Dr Uma Devi, MD Mediciti Hospital
Principal Investigator: Dr Sanjay Kolte Kolte, DNB., FCPS Sahyadri Speciality Hospital
Principal Investigator: Dr Sandeep Nijhwan Nijhwan, MD., DM SMS Medical College and Hospital
Principal Investigator: Dr. Nitin Pai, MD., DM Ruby Hall clinic
  More Information

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: September 14, 2016
Health Authority: India: Drugs Controller General of India

Keywords provided by Stempeutics Research Pvt Ltd:
Alcoholic
Liver
Cirrhosis
Stem
Cells

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Liver Cirrhosis, Alcoholic
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 30, 2016