Clinical trial NCT01591200: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholic Liver Cirrhosis
Keywords: Alcoholic
Liver
Cirrhosis
Stem
Cells
Lead sponsor: Stempeutics Research Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2012-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety
timeFrame: 2 years
Secondary outcomes:
measure: Liver function tests.
timeFrame: 2 years
measure: CT scan of abdomen.
timeFrame: 2 years
measure: Change in MELD score
timeFrame: 2 years
measure: Improvement in quality of life as assessed by SF 36 questionnaire
timeFrame: 2 years
measure: Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA
timeFrame: 6 Months
measure: Change in Child-Pugh score
timeFrame: 2 years
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Centre for Liver Research & Diagnostics
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Mediciti Hospital
state: Andhra Pradesh
city: Bangalore
country: India
facility: Manipal Hospital
state: Karnataka
city: Mangalore
country: India
facility: KMC Hospital
state: Karnataka
city: Mumbai
country: India
facility: Institute of liver disease, HPB surgery and transplant Global Hospitals
state: Maharashtra
city: Mumbai
country: India
facility: Bombay Hospital & Medical Research Center
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall clinic
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Speciality Hospital
state: Maharashtra
city: Jaipur
country: India
facility: SMS Medical college and Hospital
state: Rajasthan
city: Lucknow
country: India
facility: SGPGI Lucknow
state: Uttar Pradesh
Study officials:
affiliation: KMC, Mangalore
name: Dr. BV Tantry, MD., DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Breach Candy Hospital, Mumbai
name: Dr. Samir Shah, MD., DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Manipal Hospital, India
name: Dr. Dinesh Kini, MD., DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Bombay Hospital & Medical Research Center, Mumbai
name: Dr.Deepak N Amarapuraka, MD., DM
role: PRINCIPAL_INVESTIGATOR
affiliation: SGPGI, Kucknow
name: Dr. VA Saraswat, MD., DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Liver Research & Diagnostics, Hyderabad
name: Dr. Aejaz Habeeb, MD., DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Mediciti Hospital
name: Dr Uma Devi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahyadri Speciality Hospital
name: Dr Sanjay Kolte Kolte, DNB., FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: SMS Medical College and Hospital
name: Dr Sandeep Nijhwan Nijhwan, MD., DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruby Hall clinic
name: Dr. Nitin Pai, MD., DM
role: PRINCIPAL_INVESTIGATOR
References: