Autologous Endothelial Progenitor Cell Therapy for Reversal of Liver Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-24

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

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End Stage Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a 2 arm randomised study patients with decompensated liver cirrhosis involving 33 patients in each arm. Randomisation will be done by statistician to determine which arm patients will be in (control / treatment).

Treatment arm:

Patient will undergo CD133+ cells transplantation at stable compensated state. 5 dose Granulocyte Colony Stimulating Factor (GCSF) will be administered 5 days consecutively before bone marrow harvesting.

Approximately 250ml of bone marrow will be harvested and subjected to CD133 isolation using clinimacs (Miltenyi Biotec) in a closed system

Under ultrasound guidance, 50 mls of 50-100 million CD133 cells will be infused directly through transhepatic route into portal venous circulation of the liver over 5 mins.

Control Arm:

Patients will receive 5 doses of GCSF

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Blinding will be maintained by investigators performing analysis of the results. Given the invasive procedure of percutaneous transhepatic cannulation, the investigators felt that it will be unethical to perform sham procedure on control arm patients. Both managing doctors and patient will know which arm they are on but where not inevitable, data collection such as quality of life and results interpretation such as histology and laboratory analysis of results will be performed anonymously.

Study Groups

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Treatment

Patient will undergo CD133+ cells transplantation at stable compensated state.

5 dose GCSF will be administered 5 days consecutively before bone marrow harvesting.

Approximately 250ml of bone marrow will be harvested and subjected to CD133 isolation using clinimacs (Miltenyi Biotec) in a closed system.

Under ultrasound guidance, 50 mls of 50-100 million CD133 cells will be infused directly through transhepatic route into portal venous circulation of the liver over 5 mins.

Group Type EXPERIMENTAL

GCSF

Intervention Type DRUG

5 doses of GCSF injection will be injected under the skin on the abdomen to mobilize the bone marrow cells.

CD133 Cells Transplantation

Intervention Type PROCEDURE

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.

Control

Non-Transplant Arm:

Patients will receive 5 doses of GCSF

Group Type ACTIVE_COMPARATOR

GCSF

Intervention Type DRUG

5 doses of GCSF injection will be injected under the skin on the abdomen to mobilize the bone marrow cells.

Interventions

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GCSF

5 doses of GCSF injection will be injected under the skin on the abdomen to mobilize the bone marrow cells.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Other Intervention Names

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Endothelial Progenitor cells

Eligibility Criteria

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Inclusion Criteria

* Liver cirrhosis of any aetiology but where active disease is controlled
* Childs A/B/C with Child-Pugh score \>= 5

And either one of the following:

1. MELD score 10-27
2. Clinically significant portal hypertension as evidenced by gastroesophageal varices or ascites

Exclusion Criteria

* MELD score \>27
* INR\>2.5
* HIV
* History of hematological or hepatic malignancy within 5 years from consent
* Other underlying malignancy with \<1 year survival
* Presence of systemic diseases that may impact survival within 1 year.
* Listed for liver transplant

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No