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

Alcoholic Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591200
• Other study ID #: SRPL/LC/09-10/001
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2012
• Last updated: September 14, 2016
• Start date: June 2012
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Stempeutics Research Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholic Liver Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Alcoholic

Intervention

Biological:
• Allogeneic Mesenchymal Stem Cells
High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
• Allogeneic Mesenchymal Stem Cells
Intermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
• Allogeneic Mesenchymal Stem Cells
Low dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery

Locations

Country	Name	City	State
India	Manipal Hospital	Bangalore	Karnataka
India	Centre for Liver Research & Diagnostics	Hyderabad	Andhra Pradesh
India	Mediciti Hospital	Hyderabad	Andhra Pradesh
India	SMS Medical college and Hospital	Jaipur	Rajasthan
India	SGPGI Lucknow	Lucknow	Uttar Pradesh
India	KMC Hospital	Mangalore	Karnataka
India	Bombay Hospital & Medical Research Center	Mumbai	Maharashtra
India	Institute of liver disease, HPB surgery and transplant Global Hospitals	Mumbai	Maharashtra
India	Ruby Hall clinic	Pune	Maharashtra
India	Sahyadri Speciality Hospital	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Stempeutics Research Pvt Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	The type of adverse events, number of adverse events and proportion of patients with adverse events	2 years	Yes
Secondary	Liver function tests.	To assess the improvement in liver function	2 years	No
Secondary	CT scan of abdomen.	To assess the improvement in liver structure	2 years	No
Secondary	Change in MELD score	To assess the clinical improvement	2 years	No
Secondary	Improvement in quality of life as assessed by SF 36 questionnaire	To assess the improvement in quality of life	2 years	No
Secondary	Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA	To assess the improvement in histopathology	6 Months	No
Secondary	Change in Child-Pugh score	To assess clinical improvement	2 years	No