Study to evaluate the safety and efficacy of EBDLR in patient with liver failure.

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). - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097452

Enrollment

Registered

2025-11-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K77- Liver disorders in diseases classified elsewhere

Interventions

Intervention1: Extracorporeal Bioengineered Dual-Cell Liver Regeneration System: EBDLR is a bioengineered device which has employed principles of engineering and biotechnology in sync. It function

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of the EBDLR in patients with Acute-on-Chronic Liver Failure (ACLF) & Acute Liver Failure Timepoint: Improvement in Liver parameters from baseline to 3-4 weeks	—

Secondary

Measure	Time frame
To evaluate the effect of EBDLR device performance when administered along with the standard of careTimepoint: Improvement in Liver parameters between 5-6 weeks	—

Countries

India

Contacts

Public ContactDr Mahesh Gopasetty

YKRITA Life Sciences Pvt. Ltd

maheshgopasetty@ykrita.in8056027857

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026