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Autologous Endothelial Progenitor Cell Therapy for Reversal of Liver Cirrhosis

NCT03109236 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-01-19

No results posted yet for this study

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.

Conditions

  • End Stage Liver Disease

Interventions

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.

Sponsors & Collaborators

  • Singapore General Hospital

    collaborator OTHER

  • Tan Tock Seng Hospital

    collaborator OTHER

  • Changi General Hospital

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Dan Yock Young · National University Hospital, Singapore

  • Mark Muthiah · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-24
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03109236 on ClinicalTrials.gov