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CTRI Number  CTRI/2012/04/002560 [Registered on: 10/04/2012] Trial Registered Prospectively
Last Modified On: 04/09/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Stem Cell Therapy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the safety and efficacy of stem cells in alcoholic liver cirrhosis 
Scientific Title of Study   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 
Secondary IDs if Any  
Secondary ID  Identifier 
SRPL/LC/09-10/001, version no. 5 dated 7-6-2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pawan Kumar Gupta 
Designation  Director Medical Services 
Affiliation  Stempeutics Research Pvt. Ltd. 
Address  Stempeutics Research Pvt. Ltd. Akshay Tech Park, No. 72 & 73, 2nd Floor, EPIP Zone, Phase I-Area Whitefield, Bangalore

Bangalore
KARNATAKA
560066
India 
Phone  080-39992405  
Fax  080-39992402  
Email  pawan.kumarg@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anoop CH 
Designation  Manager Clinical Research 
Affiliation  Stempeutics Research Pvt. Ltd. 
Address  Stempeutics Research Pvt. Ltd. Akshay Tech Park, No. 72 & 73, 2nd Floor, EPIP Zone, Phase I-Area Whitefield, Bangalore

Bangalore
KARNATAKA
560017
India 
Phone  080-39992400  
Fax  080-39992402  
Email  anoop.ch@stempeutics.com  
 
Details of Contact Person
Public Query
 
Name  Jijy Abraham 
Designation  Coordinator 
Affiliation  Stempeutics Research Pvt. Ltd. 
Address  Stempeutics Research Pvt. Ltd. Akshay Tech Park, No. 72 & 73, 2nd Floor, EPIP Zone, Phase I-Area Whitefield, Bangalore

Bangalore
KARNATAKA
560017
India 
Phone  080-39992412  
Fax  080-39992402  
Email  jijy.abraham@stempeutics.com  
 
Source of Monetary or Material Support  
Stempeutics Research Pvt Ltd  
 
Primary Sponsor  
Name  Stempeutics Research Pvt Ltd  
Address  Stempeutics Research Pvt. Ltd. Akshay Tech Park, No. 72 & 73, 2nd Floor, EPIP Zone, Phase I-Area Whitefield, Bangalore - 560066 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Narayan Amarapurkar  Bombay Hospital & Medical Research Center  Room No 5, Dept of Gastroenterology, Bombay Hospital & Medical Research Center 2nd floor MRC 12, Marine Lines, Mumbai-400020
Mumbai
MAHARASHTRA 
91-022-22067676

amarapurkar@gmail.com 
Dr Samir Shah   Breach Candy Hospital,Mumbai  Department of Gastroenterology Breach Candy Hospital, #60-A, Bhulabhai Desai Road, Cumballa Hill, Mumbai- 400026
Mumbai
MAHARASHTRA 
020-23535591
020-23534519
drshahsamir@gmail.com 
Dr Aejaz Habeeb  Centre for Liver Research & Diagnostics  109, Ist Floor, Centre for Liver Research & Diagnostics (Name of the site), Department of Gastroentrology & Hepatology Deccan College of Medical Sciences, Owaisi Hospital & Research Centre Campus Kanchanbagh, Hyderabad
Hyderabad
ANDHRA PRADESH 
91-40-24342954
91-40-24342954
aejazhabeeb@hotmail.com 
Dr Vivek Anand Saraswat  Department of Gastroenterology, Sanjay Gandhi Post Graduate Institute of Medical Sciences  Department of Gastroenterology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Lucknow - 226014
Lucknow
UTTAR PRADESH 
91-522-2494407
91-522-2668017
profviveksaraswat@gmail.com 
Dr B V Tantry   KMC Hospital,Mangalore  Room No 5089, Dept of Gastroenterology, KMC Hospital, Jyothi Circle, Mangalore- 575001
Bangalore
KARNATAKA 
0824-2444590

tantrybv@gmail.com 
Dr Raj Vigna Venugopal  Manipal Hospital  No 1, -1 Floor, Department of Gastroenterology, Manipal Hospital, 98, HAL Airport Road, Bangalore - 560017
Bangalore
KARNATAKA 
080-25204631
080-25207181
v2raj@rediffmail.com 
Dr Uma Devi  Mediciti Hospital  Gastroenterology Hospital building Ground Floor Room No 2 Mediciti Hospital 5- 9- 22, Secratariat road Hyderabad- 500063
Hyderabad
ANDHRA PRADESH 
04023299078
04023299078
umadevimalladi_66@yahoo.co.in 
Dr Nitin Pai  Ruby Hall clinic  Department of Gastroenterology New cancer building 6th floor Ruby Hall clinic 40, Sassoon Road Pune - 411001
Pune
MAHARASHTRA 
02066455100
02026124529
drnitinpai@gmail.com 
Dr Sanjay Kolte  Sahyadri Speciality Hospital  Dept of Surgery Behind Casualty Ground floor OPD - 2 Sahyadri Speciality Hospital 30 C Erandwane, Karve Road Near Vimlabai Garware High School Pune 411004
Pune
MAHARASHTRA 
02067213000
02025459117
sanjaykotle@yahoo.com 
Dr Sandeep Nijhwan  SMS Medical college and Hospital  Department of Gastroenterology Hospital building 2nd floor SMS Medical college and Hospital J.L.N. Marg, Jaipur - 302004
Jaipur
RAJASTHAN 
01412575466
01412575466
drnijhawansandeep@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Bombay hospital Ethics Committee, Bombay Hospital  Submittted/Under Review 
Breach candy medical research centre, Breach Candy Hospital  Approved 
Ethics Committee SMS Hospital Jaipur  Approved 
IEC Consultants, Bangalore, applicable for Dr. Raj Vigna Venugopal, Manipal Hospital  Approved 
Institutional Ethics committee Deccan College of Medical Sciences  Approved 
Manipal university Ethics committee, Manipal University  Approved 
Mediciti Ethics Committee  Approved 
Poona Medical Research Foundation for Dr. Nitin Pai, Ruby Hall Clinic  Approved 
Sahyadri Hospitals Ltd. Ethics Committee  Approved 
SGPGI Ethics Committee, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Alcoholic liver cirrhosis ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Allogeneic mesenchymal stem cells - high dose  Bone marrow derived mesenchymal stem cells derived from healthy human volunteers will be administered through hepatic artery, in a volume of less than or equal to 50 ml. This arm will receive single high dose of stem cells and will be followed up till 2 years after the injection. 
Intervention  Allogeneic mesenchymal stem cells - intermediate dose  Bone marrow derived mesenchymal stem cells derived from healthy human volunteers will be administered through hepatic artery, in a volume of less than or equal to 50 ml. This arm will receive single intermediate dose of stem cells and will be followed up till 2 years after the injection. 
Intervention  Allogeneic mesenchymal stem cells - low dose  Bone marrow derived mesenchymal stem cells derived from healthy human volunteers will be administered through hepatic artery, in a volume of less than or equal to 50 ml. This arm will receive single low dose of stem cells and will be followed up till 2 years after the injection. 
Comparator Agent  Standard protocol of care  Patients will receive standard protocol of care for alcoholic liver cirrhosis. Each patient will be followed up till the end of two years. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological [CT scan] or histological evidence of cirrhosis and portal hypertension).

2. Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7 and <14).

3. MELD scores of at least 10 (UNOS Meld calculator).

4. Normal AFP Level

5. Hb>10gm/dl.

6. Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study

7. Signed informed consent.  
 
ExclusionCriteria 
Details  1. Patients likely to undergo liver transplantation during the duration of the study.

2. Presence of advanced hepatic encephalopathy Grades 3 & 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening

3. Active variceal bleed.

4. Refractory ascites.

5. Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.

6. Platelet count 30,000/mm3.

7. Serum Sodium 129mEq/L.

8. Serum Creatinine 2 mg/dl.

9. Hepatocellular carcinoma or other malignancies

10. Active infectious disease.

11. Presence of severe underlying cardiac, pulmonary or renal disease.

12. Excessive alcohol (30 gm of alcohol/day) use in the last 3 months before screening.

13. Positive HbSAg or antibodies to HIV or HCV.

14. Pregnancy or lactation.

15. Participation in other clinical trials.

16. Unwilling/unable to sign the informed consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the safety and tolerability following a single dose of allogeneic mesenchymal stem cells administered via the percutaneous puncture of the femoral artery followed by selective cannulation of the hepatic artery (Seldinger Technique) in Alcoholic Liver Cirrhosis patients  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the potential of allogeneic mesenchymal stem cells to improve the liver function and quality of life in Alcoholic Liver Cirrhosis patients  2years 
To find the suitable dose of allogeneic mesenchymal stem cells to improve the liver function and quality of life in Alcoholic Liver Cirrhosis patients  2years 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   24/04/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Brief Summary   This study is for evaluating the safety and efficacy of allogeneic mesenchymal stem cells in patients with alcoholic liver cirrhosis. Different doses of stem cells will be studied in this trial and compared with standard protocol of care.
 
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