NCT01591200CompletedPhase 2
A Parallel Group Randomized Open Blinded End Point Evaluation, Multicentric, Dose Escalation, Phase -II Study Assessing the Safety and Efficacy of Intraarterial (Hepatic) Ex-vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Alcoholic Liver Cirrhosis
Stempeutics Research Pvt Ltd20 sites in 1 country40 target enrollmentStarted: June 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Stempeutics Research Pvt Ltd
- Enrollment
- 40
- Locations
- 20
- Primary Endpoint
- Safety
Study Overview
Brief Summary
This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological [CT scan] or histological evidence of cirrhosis and portal hypertension).
- •Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7 and <14).
- •MELD scores of at least 10 (UNOS Meld calculator).
- •Normal AFP Level
- •Hb>10gm/dl.
- •Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
- •Signed informed consent.
Exclusion Criteria
- •Patients likely to undergo liver transplantation during the duration of the study.
- •Presence of advanced hepatic encephalopathy Grades 3 & 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening
- •Active variceal bleed.
- •Refractory ascites.
- •Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.
- •Platelet count < 30,000/mm
- •Serum Sodium <129mEq/L.
- •Serum Creatinine > 2 mg/dl.
- •Hepatocellular carcinoma or other malignancies
- •Active infectious disease.
- •Presence of severe underlying cardiac, pulmonary or renal disease.
- •Excessive alcohol (>30 gm of alcohol/day) use in the last 3 months before screening.
- •Positive HbSAg or antibodies to HIV or HCV.
- •Pregnancy or lactation.
- •Participation in other clinical trials.
- •Unwilling/unable to sign the informed consent.
Outcomes
Primary Outcomes
Safety
Time Frame: 2 years
The type of adverse events, number of adverse events and proportion of patients with adverse events
Secondary Outcomes
- Liver function tests.(2 years)
- CT scan of abdomen.(2 years)
- Change in MELD score(2 years)
- Improvement in quality of life as assessed by SF 36 questionnaire(2 years)
- Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA(6 Months)
- Change in Child-Pugh score(2 years)
Investigators
Study Sites (20)
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