100
Participants
Start Date
January 31, 2028
Primary Completion Date
December 31, 2031
Study Completion Date
December 31, 2031
Umbilical cord Mesenchymal stem cell
ucMSC 1 million/kg will be given once a week for 4 week . 250 ml normal saline will be infused 30 minutes prior to ucMSCs infusion. The fresh ucMSCs will then be infused through IV canula peripherally over 30 minutes followed by a further 250 ml normal saline over 20-30 minutes.
Steroid
Prednisolone 40 mg once daily for 7 days as inpatients. After that Lille score will be calculated on day 7. Responders (Lille score \< 0.45) will be continued on steroids for a total of 4 weeks, followed by 2 weeks oftapering before stopping the therapy. In patients who were non responsive to steroids (Lille score \> 0.45) at day 7, steroids will be stopped at day 7 and will receive only SMT.
Standard Medical Treatment
All patients will receive the standard medical treatment.
All India Institutes of Medical Sciences (AIIMS), New Delhi
Institute of Liver & Biliary Sciences, New Delhi
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Indian Council of Medical Research
OTHER_GOV
Institute of Liver and Biliary Sciences, India
OTHER