FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/097452 [Registered on: 14/11/2025] Trial Registered Prospectively
Last Modified On: 07/09/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to evaluate the safety and efficacy of EBDLR in patient with liver failure. 
Scientific Title of Study   A multi-center, single arm study to evaluate the safety, tolerability and performance of Extracorporeal Bioengineered Dual Cell Liver Regeneration System [EBDLR System] in patients suffering from Acute on Chronic Liver Failure (ACLF) and Acute Liver Failure (ALF) along with the Standard of Care (SoC). 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CI/MD/2025/000010 Prortocol Version 3 dated 03 OCT 2025_  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh Gopasetty  
Designation  Coordinating Investigator 
Affiliation  YKRITA Life Sciences Pvt. Ltd 
Address  Regd Office 269, 5th Main Road, 9th Cross Road, Tata Nagar, Bengaluru

Bangalore
KARNATAKA
560092
India 
Phone  8056027857  
Fax    
Email  maheshgopasetty@ykrita.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahesh Gopasetty  
Designation  Coordinating Investigator 
Affiliation  YKRITA Life Sciences Pvt. Ltd 
Address  Regd Office 269, 5th Main Road, 9th Cross Road, Tata Nagar, Bengaluru


KARNATAKA
560092
India 
Phone  8056027857  
Fax    
Email  maheshgopasetty@ykrita.in  
 
Details of Contact Person
Public Query  
Name  Dr Mahesh Gopasetty  
Designation  Coordinating Investigator 
Affiliation  YKRITA Life Sciences Pvt. Ltd 
Address  Regd Office 269, 5th Main Road, 9th Cross Road, Tata Nagar, Bengaluru


KARNATAKA
560092
India 
Phone  8056027857  
Fax    
Email  maheshgopasetty@ykrita.in  
 
Source of Monetary or Material Support  
YKRITA Life Sciences Pvt. Ltd. Regd. Office: # 269, 5th Main Road, 9th Cross Road, Tata Nagar, Bengaluru- 560092, Karnataka, INDIA 
 
Primary Sponsor  
Name  YKRITA Life Sciences Pvt. Ltd. 
Address  Regd. Office: # 269, 5th Main Road, 9th Cross Road, Tata Nagar, Bengaluru- 560092, Karnataka, INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anand Kulkarni  Asian Institute of Gastroenterology Hospital  Room no. 2, Department of Gastroenterology, 1-66/AIG/2 to 5, Mindspace Road, Gachibowli, Hyderabad, Telangana 500032, India
Hyderabad
TELANGANA 		 8553322434
8553322434
anandvk90@gmail.com 
Dr Manav Wadhawa  BLK MAX Super Speciality Hospital  Room no. 2, Department of Gastroenterology, Building No-5, Pusa Road, Karol Bagh, Delhi NCR, NCT Delhi - 110005
North East
DELHI 		 9818677890
9818677890
manavwadhawan@gmail.com  
Dr Ravindra B S  Fortis Hospital  Room no. 2, Department of Gastroenterology, 154, 9, Bannerghatta Rd, opposite IIM, Sahyadri Layout, Panduranga Nagar, Bengaluru, Karnataka 560076
Bangalore
KARNATAKA 		 9916636144
9916636144
ravindra.bs@fortishealthcare.com  
Dr S K Sarin  Institute of Liver and Biliary Sciences   Room no. 2, Department of Gastroenterology, D-1, Vasant Kunj, New Delhi
South West
DELHI 		 01146300000
01146300000
shivsarin@gmail.com 
Dr Deepak Suvarna   Jagadguru Sri Shivarathreeshwara Mahaswamiji Hospital  Room no. 2, Department of Gastroenterology, Mahathma Gandhi Road Mysuru - 570004, Karnataka, India
Mysore
KARNATAKA 		 9964380249
9964380249
drdeepaksuvarna@gmail.com  
Dr Akash Shukla  King Edward Memorial Hospital  Room no. 2, Department of Gastroenterology, Acharya Donde Marg, Dr. Ernest Borges Road, Parel, Mumbai – 400012, Maharashtra (Opposite Tata & Wadia Hospital)
Mumbai
MAHARASHTRA 		 9137009394
9137009394
drakashshukla@yahoo.com  
Dr Vidyasagar Ramappa   Manipal Hospital  Room no. 2, Department of Gastroenterology, 26/4, Brigade Gateway, Yeshwanthpur, beside Metro, Malleshwaram, Bengaluru, 560055, KA, India
Bangalore
KARNATAKA 		 9538671818
9538671818
vidyasagar.r@manipalhospitals.com 
Dr Shweta Singh   Max Super Speciality Hospital  Room no. 2, Department of Gastroenterology, No. 1, 2, Press Enclave Road, Mandir Marg, Saket Institutional Area, Saket, New Delhi, Delhi,
South West
DELHI 		 9810625177
9810625177
drshwetasingh29@gmail.com  
Dr Vinay B N  PMSSY Super Speciality Hospital  Room no. 2, Department of Gastroenterology, BMC&RI/Victoria Hospital Campus, K.R. Road, Bengaluru - 560002, Karnataka, India
Bangalore
KARNATAKA 		 9972121844
9972121844
drvinaybngisurgeon@gmail.com 
Mallikarjun Patil  St Johns Medical College Hospital  193 1, Hosur Road,Sarjapur Marathahalli Rd, Santhosapuram, Koramangala Industrial Layout, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA 		 9740531789

drmalli_arjun@yahoo.co.in 
Dr MakeNaveen Chand  Visakha Institute of Medical Sciences   Room no. 2, Department of Gastroenterology,NH -16, Hanumanthavaka Junction, Visakhapatnam – 530 040, AP, India
Visakhapatnam
ANDHRA PRADESH 		 9885837772
9885837772
drmnaveenchandresearch@gmail.com  
Dr Anand K Khakhar  Zydus Hospital  Room no. 2, Department of Gastroenterology, Zydus Hospital Rd, Sola, Ahmedabad-380059, Gujarat
Ahmadabad
GUJARAT 		 9662116781
9662116781
anandkhakhar@zydushospital.com  
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Dr. B L Kapur Memorial Hospital Ethics Committee  Submittted/Under Review 
Ethics Committee of BMCRI  Submittted/Under Review 
Fortis Hospital Ethics Committee  Approved 
Institutional Ethics Committee -l Seth GS Medical College and KEM Hospital  Submittted/Under Review 
Institutional Ethics Committee, Asian Institute of Gastroenterology  Submittted/Under Review 
Institutional Ethics Committee, Institute of Liver and Biliary Sciences  Submittted/Under Review 
Institutional Ethics Committee, JSS Medical College JSS Hospital,  Approved 
Institutional Ethics Committee, Visakha Institute Of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee Manipal Hospital Yeshwanthpur  Approved 
Institutional Ethics Committee St Johns Medical College Hospital   Approved 
Max Health Ethics Committee  Submittted/Under Review 
Zydus Hospital Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Extracorporeal Bioengineered Dual-Cell Liver Regeneration System  EBDLR is a bioengineered device which has employed principles of engineering and biotechnology in sync. It function as native liver (both synthetic and detoxifying.) Device takes care of a safe method to withdraw and circulate blood and plasma through the system 
Comparator Agent  Placebo  function as native liver (both synthetic and detoxifying.) It takes care of a safe method to withdraw and circulate blood and plasma through the system 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  i. Patients aged 18 years and 70
years both the genders.
ii. Patients or LAR IW able to provide
informed consent voluntarily to
participate in the study.
Patients with known unknown liver
disease.
iv. If known, patient diagnosed with
ACLF Grade 1, 2 or 3a defined as
per the CLIF C OF score system.
v. Patients with no obvious
decompensation or admission to
hospital in the past 30 days prior to
the current visit.
vi. PT International Normalized Ratio
1.5
vii. Bilirubin 5 mg per dL.
viii. Serum Creatinine 2 mg per dL with or
without ascites or encephalopathy.
ix. Mean arterial pressure of 60 mmHg.  
 
ExclusionCriteria 
Details  Patients with hemodynamic instability
not responding to modest inotropic
support.
2. Patients on hemodialysis support.
3. Uncontrolled infection or sepsis that is not
responding to antibiotics.
4. Patients with more than three organ
system failure at presentation.
Patient with Acute Myocardial
Infarction.
6. Signs of intracranial bleed.
7. Pregnancy
8. History of malignancy that has not been
cured or any cancer in remission for less
than 1 year.
9. Any other health condition that would
preclude participation in the study in
the judgment of the site principal
investigator.
10. Patients with a known allergy to heparin
or have type II thrombocytopenia
caused by heparin.
11. In the opinion of the investigator, the
patient is unsafe for the study can be
excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety of the EBDLR in patients with Acute-on-Chronic Liver
Failure (ACLF) & Acute Liver Failure
 		 Improvement in Liver parameters from baseline to 3-4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of EBDLR device performance when administered along
with the standard of care 		 Improvement in Liver parameters between 5-6 weeks 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   28/11/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The device discussed in this proposal caters to this need for external-hepatic support to individuals with failing liver. EBDLR practically takes over the functions of a native liver (both synthetic and detoxification) when connected to a patient. This is a bioengineered device which has employed principles of engineering and biotechnology in sync. The engineering aspect of the device takes care of a safe method to withdraw and circulate blood and plasma through the system. Biotechnology approach ensures that the plasma is detoxified by the specialized cells present in the bio-purifier. External detoxification enables the native/injured liver to regenerate aiding the patient’s survival.  
Close