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
1 other identifier
interventional
40
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2012
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedSeptember 15, 2016
September 1, 2016
3.8 years
April 15, 2012
September 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
The type of adverse events, number of adverse events and proportion of patients with adverse events
2 years
Secondary Outcomes (6)
Liver function tests.
2 years
CT scan of abdomen.
2 years
Change in MELD score
2 years
Improvement in quality of life as assessed by SF 36 questionnaire
2 years
Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA
6 Months
- +1 more secondary outcomes
Study Arms (4)
Control
NO INTERVENTIONThis arm will receive standard protocol of care alone
Stem cells high dose
EXPERIMENTALThis arm will receive high dose of Allogeneic Mesenchymal Stem Cells
Stem cells intermediate dose
EXPERIMENTALThis arm will receive intermediate dose of Allogeneic Mesenchymal Stem Cells
Stem cells low dose
EXPERIMENTALThis arm will receive low dose of Allogeneic Mesenchymal Stem Cells
Interventions
High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Centre for Liver Research & Diagnostics
Hyderabad, Andhra Pradesh, 500058, India
Mediciti Hospital
Hyderabad, Andhra Pradesh, 500063, India
Manipal Hospital
Bangalore, Karnataka, 560017, India
KMC Hospital
Mangalore, Karnataka, 575001, India
Institute of liver disease, HPB surgery and transplant Global Hospitals
Mumbai, Maharashtra, 400012, India
Bombay Hospital & Medical Research Center
Mumbai, Maharashtra, 400020, India
Ruby Hall clinic
Pune, Maharashtra, 411001, India
Sahyadri Speciality Hospital
Pune, Maharashtra, 411004, India
SMS Medical college and Hospital
Jaipur, Rajasthan, 302004, India
SGPGI Lucknow
Lucknow, Uttar Pradesh, 226014, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. BV Tantry, MD., DM
KMC, Mangalore
- PRINCIPAL INVESTIGATOR
Dr. Samir Shah, MD., DM
Breach Candy Hospital, Mumbai
- PRINCIPAL INVESTIGATOR
Dr. Dinesh Kini, MD., DM
Manipal Hospital, India
- PRINCIPAL INVESTIGATOR
Dr.Deepak N Amarapuraka, MD., DM
Bombay Hospital & Medical Research Center, Mumbai
- PRINCIPAL INVESTIGATOR
Dr. VA Saraswat, MD., DM
SGPGI, Kucknow
- PRINCIPAL INVESTIGATOR
Dr. Aejaz Habeeb, MD., DM
Centre for Liver Research & Diagnostics, Hyderabad
- PRINCIPAL INVESTIGATOR
Dr Uma Devi, MD
Mediciti Hospital
- PRINCIPAL INVESTIGATOR
Dr Sanjay Kolte Kolte, DNB., FCPS
Sahyadri Speciality Hospital
- PRINCIPAL INVESTIGATOR
Dr Sandeep Nijhwan Nijhwan, MD., DM
SMS Medical College and Hospital
- PRINCIPAL INVESTIGATOR
Dr. Nitin Pai, MD., DM
Ruby Hall clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2012
First Posted
May 3, 2012
Study Start
June 1, 2012
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
September 15, 2016
Record last verified: 2016-09