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

Primary Purpose

Alcoholic Liver Cirrhosis

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Allogeneic Mesenchymal Stem Cells

About this trial

This is an interventional treatment trial for Alcoholic Liver Cirrhosis focused on measuring Alcoholic, Liver, Cirrhosis, Stem, Cells

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological [CT scan] or histological evidence of cirrhosis and portal hypertension).
Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7 and <14).
MELD scores of at least 10 (UNOS Meld calculator).
Normal AFP Level
Hb>10gm/dl.
Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
Signed informed consent.

Exclusion Criteria:

Patients likely to undergo liver transplantation during the duration of the study.
Presence of advanced hepatic encephalopathy Grades 3 & 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening
Active variceal bleed.
Refractory ascites.
Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.
Platelet count < 30,000/mm3.
Serum Sodium <129mEq/L.
Serum Creatinine > 2 mg/dl.
Hepatocellular carcinoma or other malignancies
Active infectious disease.
Presence of severe underlying cardiac, pulmonary or renal disease.
Excessive alcohol (>30 gm of alcohol/day) use in the last 3 months before screening.
Positive HbSAg or antibodies to HIV or HCV.
Pregnancy or lactation.
Participation in other clinical trials.
Unwilling/unable to sign the informed consent.

Sites / Locations

Centre for Liver Research & Diagnostics
Mediciti Hospital
Manipal Hospital
KMC Hospital
Institute of liver disease, HPB surgery and transplant Global Hospitals
Bombay Hospital & Medical Research Center
Ruby Hall clinic
Sahyadri Speciality Hospital
SMS Medical college and Hospital
SGPGI Lucknow

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Arm Label

Control

Stem cells high dose

Stem cells intermediate dose

Stem cells low dose

Arm Description

This arm will receive standard protocol of care alone

This arm will receive high dose of Allogeneic Mesenchymal Stem Cells

This arm will receive intermediate dose of Allogeneic Mesenchymal Stem Cells

This arm will receive low dose of Allogeneic Mesenchymal Stem Cells

Outcomes

Primary Outcome Measures

Safety

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

Secondary Outcome Measures

Liver function tests.

To assess the improvement in liver function

CT scan of abdomen.

To assess the improvement in liver structure

Change in MELD score

To assess the clinical improvement

Improvement in quality of life as assessed by SF 36 questionnaire

To assess the improvement in quality of life

Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA

To assess the improvement in histopathology

Change in Child-Pugh score

To assess clinical improvement

Full Information

NCT ID

NCT01591200

First Posted

April 15, 2012

Last Updated

September 14, 2016

Sponsor

Stempeutics Research Pvt Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01591200

Brief Title

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

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 Allogenic Mesenchymal Stem Cells in Patients With Alcoholic Liver Cirrhosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stempeutics Research Pvt Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcoholic Liver Cirrhosis

Keywords

Alcoholic, Liver, Cirrhosis, Stem, Cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

This arm will receive standard protocol of care alone

Arm Title

Stem cells high dose

Arm Type

Experimental

Arm Description

This arm will receive high dose of Allogeneic Mesenchymal Stem Cells

Arm Title

Stem cells intermediate dose

Arm Type

Experimental

Arm Description

This arm will receive intermediate dose of Allogeneic Mesenchymal Stem Cells

Arm Title

Stem cells low dose

Arm Type

Experimental

Arm Description

This arm will receive low dose of Allogeneic Mesenchymal Stem Cells

Intervention Type

Biological

Intervention Name(s)

Allogeneic Mesenchymal Stem Cells

Intervention Description

High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery

Intervention Type

Biological

Intervention Name(s)

Allogeneic Mesenchymal Stem Cells

Intervention Description

Intermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery

Intervention Type

Biological

Intervention Name(s)

Allogeneic Mesenchymal Stem Cells

Intervention Description

Low dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery

Primary Outcome Measure Information:

Title

Safety

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Liver function tests.

Description

To assess the improvement in liver function

Time Frame

2 years

Title

CT scan of abdomen.

Description

To assess the improvement in liver structure

Time Frame

2 years

Title

Change in MELD score

Description

To assess the clinical improvement

Time Frame

2 years

Title

Improvement in quality of life as assessed by SF 36 questionnaire

Description

To assess the improvement in quality of life

Time Frame

2 years

Title

Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA

Description

To assess the improvement in histopathology

Time Frame

6 Months

Title

Change in Child-Pugh score

Description

To assess clinical improvement

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological [CT scan] or histological evidence of cirrhosis and portal hypertension). Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7 and <14). MELD scores of at least 10 (UNOS Meld calculator). Normal AFP Level Hb>10gm/dl. Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study Signed informed consent. Exclusion Criteria: Patients likely to undergo liver transplantation during the duration of the study. Presence of advanced hepatic encephalopathy Grades 3 & 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening Active variceal bleed. Refractory ascites. Evidences of autoimmune liver disease- ANA or Anti-LKM positivity. Platelet count < 30,000/mm3. Serum Sodium <129mEq/L. Serum Creatinine > 2 mg/dl. Hepatocellular carcinoma or other malignancies Active infectious disease. Presence of severe underlying cardiac, pulmonary or renal disease. Excessive alcohol (>30 gm of alcohol/day) use in the last 3 months before screening. Positive HbSAg or antibodies to HIV or HCV. Pregnancy or lactation. Participation in other clinical trials. Unwilling/unable to sign the informed consent.

Overall Study Officials: