NCT01591200

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Stempeutics Research Pvt Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholic Liver Cirrhosis

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Mesenchymal Stem Cells	High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
BIOLOGICAL	Allogeneic Mesenchymal Stem Cells	Intermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
BIOLOGICAL	Allogeneic Mesenchymal Stem Cells	Low dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2012-05-03
• Last updated: 2016-09-15

Locations

10 sites across 1 country: India