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Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01591200•Stempeutics Research Pvt Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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.
+6 more criteria

Locations (10)

Centre for Liver Research & Diagnostics

Hyderabad, Andhra Pradesh, India

Mediciti Hospital

Hyderabad, Andhra Pradesh, India

Manipal Hospital

Bangalore, Karnataka, India

KMC Hospital

Mangalore, Karnataka, India

Institute of liver disease, HPB surgery and transplant Global Hospitals

Mumbai, Maharashtra, India

Bombay Hospital & Medical Research Center

Mumbai, Maharashtra, India

Ruby Hall clinic

Pune, Maharashtra, India

Sahyadri Speciality Hospital

Pune, Maharashtra, India

SMS Medical college and Hospital

Jaipur, Rajasthan, India

SGPGI Lucknow

Lucknow, Uttar Pradesh, India

Key Dates

Start Date

June 1, 2012

Primary Completion Date

April 1, 2016

Completion Date

April 1, 2016

Last Updated

September 15, 2016

Enrollment

ACTUAL participants

Conditions

Alcoholic Liver Cirrhosis

Interventions

Allogeneic Mesenchymal Stem Cells

BIOLOGICAL

Allogeneic Mesenchymal Stem Cells

BIOLOGICAL

Allogeneic Mesenchymal Stem Cells

BIOLOGICAL

Study to Evaluate Hepatic Artery Injection of Autologous Human Bone Marrow-Derived MSCs in Patients With Alcoholic LC

NCT03838250

Alcoholic Liver Cirrhosis

View study

COMPLETEDPHASE2

REVIVE(Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic Liver Cirrhosis Patient)

NCT01875081

Alcoholic Liver Cirrhosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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