NCT03109236

Autologous Endothelial Progenitor Cell Therapy for Reversal of Liver Cirrhosis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This proposal translates a hypothesis driven basic research into clinical setting to determine the potential of using autologous CD133+ cells to reverse fibrosis and improve clinical outcome for patients with end stage cirrhosis. This has significant impact on the management of cirrhosis.

Detailed description

This is a 2 arm randomised study patients with decompensated liver cirrhosis involving minimum of 23 and maximum of 33 patients in each arm. The investigators propose that transplantation of mobilized autologous CD133+ cells harvested from the bone marrow directly into the liver has the ability to replace and regenerate the damaged sinusoidal endothelium as well as normalize macrophage and Natural Killer (NK) cell function. The niche provided by the refenestrated endothelium can polarize the macrophage to antifibrotic phenotype as well as directly inactivate the activated myofibroblast, resulting in reversal of liver fibrosis and improvement in liver function. Transplantation of cells will be via intraportal route delivered by percutaneous cannulation of the portal vein system.

Conditions

• End Stage Liver Disease

Interventions

Type	Name	Description
DRUG	GCSF	5 doses of GCSF injection will be injected under the skin on the abdomen to mobilize the bone marrow cells.
PROCEDURE	CD133 Cells Transplantation	Endothelial progenitor cells are harvested by CD133+ MACS (magnetic activated cell sorting) sort selection of bone marrow and a minimum of 1x 10\^6 and up to 50-100 x 10\^6 cells are transplanted to one lobe of the liver via a percutaneous catheter inserted into the portal venous system by percutaneous transhepatic approach for engraftment.

Timeline

• Start date: 2017-08-24
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2017-04-12
• Last updated: 2021-01-19

Locations

1 site across 1 country: Singapore