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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Alloge

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 Summary:
Sponsor: Stempeutics Research Pvt Ltd

Current Primary Outcome: Safety [ Time Frame: 2 years ]

The type of adverse events, number of adverse events and proportion of patients with adverse events


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Stempeutics Research Pvt Ltd

Dates:
Date Received: April 15, 2012
Date Started: June 2012
Date Completion:
Last Updated: September 14, 2016
Last Verified: September 2016