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National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Phase I Study on Safety and Efficacy of Mesenchymal Stem-Cell (MSC) Therapy in Non-Viral Acute-on-Chronic Liver Failure (ACLF)

ConditionAcute-On-Chronic Liver Failure
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

Liver disease deaths are rising, but transplants remain scarce in India. With over 100,000 needed annually and only \~2,500 performed, non-transplant options are urgently needed. Regenerative therapy, especially MSCs, shows promise but lacks validation, particularly for non-viral Acute on Chronic Liver Failure (ACLF). The proposed NC-CHRM aims to develop and validate MSC-based therapy to promote native liver regeneration and offer a safe, effective, transplant-free treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ACLF patients with Model for End-Stage Liver Disease (MELD) >18 or APASL ACLF Research Consortium (AARC) grade 2 or more with (no or single extrahepatic organ dysfunction or failure having no option of liver transplant).

Disqualifiers

Age <18 or >65 yrs

Patients with active sepsis

Patients with hepatic venous outflow tract obstruction (HVOTO) or Extrahepatic portal vein obstruction (EHPVO)

Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy

Trial design

Design model

Single group

Treatments tested in this trial

  • umbilical cord Mesenchymal Stem Cell

    Drug

    To test the safety and tolerability of ucMSC 1 million/kg will be given intra-venously once a week for 4 week in 10 ACLF patients. 250 ml normal saline will be infused 30 minutes prior to ucMSCs infusion. The fresh ucMSCs will be taken from ILBS cGMP facility and will be infused through IV canula peripherally over 30 minutes followed by a further 250 ml normal saline over 20-30 minutes.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Safety and feasibility of ucMSCs therapy in non-viral ACLF (Phase-1)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of ucMSC infusion in non-viral ACLF patients defined as proportion of patients completing the protocolized doses of MSC without major adverse effects requiring discontinuation.

Time frame
Day 28 and Day 90

Secondary outcomes

1

Proportion of patients developing minor adverse effects

Time frame
Day 28 and Day 90
2

Feasibility of ucMSC isolation and therapy Improvement in APASL ACLF Research Consortium (AARC) and MELD score from baseline at day 28 and day 90

Higher AARC (range: 5-15) and MELD (range: 6-40) scores indicate worse clinical status

Time frame
Day 28 and day 90
3

Incidence of sepsis (assessed by positive culture reports)

Time frame
Day 28 and Day 90
4

Incidence of renal dysfunction (evaluated by urine output and kidney function tests [KFTs])

Time frame
Day 28 and 90

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Liver and Biliary Sciences, India

Lead sponsor

Indian Council of Medical Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: