Use of stem cells which have capacity to grow to liver cells in patients of cirrhosis of liver who have jaundice, ascites( water in abdomen)

Autologous Transfusion of Mobilized Peripheral Blood CD 34 Positive Cells in Patients with Liver Cirrhosis

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/11/010429

Enrollment

195

Registered

2017-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Chronic Liver Disease ( Cirrhosis of Liver) Health Condition 2: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: CD 34 infusion: G-CSF for 5 days followed by leukapharesis and autolous CD34 cell infusion through hepatic artery Intervention2: G-CSF injections: G-CSF injections for 5 days Control In

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 20- 70 years 2. Clinically diagnosed for hepatic cirrhosis having a Child Pugh score of B or C 3. Not willing for immediate liver transplantation either due to lack of donor tissue or financial issues 4. Life expectancy of at least 3 months based on MELD score and Child Pugh Score 5. Ability to give informed consent

Exclusion criteria

Exclusion criteria: 1. Age less than 20 or more than 70 years 2. Have liver tumors or history of any other cancer 3. Pregnant or lactating women 4. Patients with hepato renal syndrome and acute kidney injury ( Any creatinine > 2 will be excluded) 5. Evidence of ongoing sepsis â?? as per Surviving sepsis guideline 6. Recent gastrointestinal bleeding or spontaneous bacterial peritonitis (within last one month) 7. Any HIV positive patients 8. Comorbid conditions such as severe cardiac and/or pulmonary disease 9. Inability to give informed consent.

Design outcomes

Primary

Measure	Time frame
To assess the improvement in liver functional status as judged MELD scoresTimepoint: 1 month, 3 month , 6 month , 1 year	—

Secondary

Measure	Time frame
To assess improvement in child Pugh score , improvement in the percentage of CD 34 cells in liver , improvement in liver function tests , survival benefit at end of 3 months , 6 months and one year, decrease in incidence of sepsis , improvement in ascites and need for therapeutic paracentesis for respiratory difficulty , improvement in hepatic encephalopathy, and decrease in GI bleed. The effect of portal pressure on the outcome of the study would also be assessed.Timepoint: 1 month, 3 month , 6 month , 1 year	—

Measure

Time frame

To assess improvement in child Pugh score , improvement in the percentage of CD 34 cells in liver , improvement in liver function tests , survival benefit at end of 3 months , 6 months and one year, decrease in incidence of sepsis , improvement in ascites and need for therapeutic paracentesis for respiratory difficulty , improvement in hepatic encephalopathy, and decrease in GI bleed. The effect of portal pressure on the outcome of the study would also be assessed.Timepoint: 1 month, 3 month , 6 month , 1 year

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Countries

India

Contacts

Public ContactMithun Sharma

Asian Institute of Gastroenterology

drmithunsharma@gmail.com08790622655

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026