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Trial record 47 of 799 for:    Interventional Studies | mesenchymal

Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT03209986
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Han Ying, Xijing Hospital of Digestive Diseases

Brief Summary:

There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients.

This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment)or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.


Condition or disease Intervention/treatment Phase
Liver Cirrhosis Procedure: mesenchymal stem cell transplantation via peripheral vein Other: mesenchymal stem cell Not Applicable

Study Type : Interventional
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors will be blind to the randomization results of the participants.
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis Resulted From Viral Hepatitis
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: MSC group
mesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8.
Procedure: mesenchymal stem cell transplantation via peripheral vein
1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8

Other: mesenchymal stem cell
mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China

No Intervention: control
Standard medication for viral hepatitis and cirrhosis



Primary Outcome Measures :
  1. Efficacy: Change of liver functions as assessed by MELD score [ Time Frame: 1 year ]
    Change of liver functions as assessed by MELD score (MELD, Model for End-Stage Liver Disease Score: MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43)

  2. Safety: Adverse events as assessed according to CTCAE 4.03 [ Time Frame: 1 year ]
    Adverse events as assessed according to CTCAE 4.03


Secondary Outcome Measures :
  1. Survival Benefit: Survival Rate at different time points [ Time Frame: 1 year, 2 year and 5 years ]
    survival rate at different time points

  2. Histological change of the liver: Histological scores assessed by liver biopsy [ Time Frame: 1 year, 2 year and 5 years ]
    histological scores assessed by liver biopsy at baseline and after treatment

  3. Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy [ Time Frame: 1, 2 and 5 years ]
    Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18-65 years
  2. HBV -related liver cirrhosis
  3. Child-Pugh score ≥7
  4. With presentations of decompensation
  5. Written consent

Exclusion Criteria:

  1. Hepatocellular carcinoma or other malignancies
  2. Severe problems in other vital organs(e.g.the heart,renal or lungs)
  3. Pregnant or lactating women
  4. Severe bacteria infection
  5. Anticipated with difficulty of follow-up observation
  6. Coinfection with HIV or other viral hepatitis.
  7. Drug abuse or alcohol abuse
  8. History of severe allergy to biological products
  9. Other candidates who are judged to be not applicable to this study by doctors -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209986


Contacts
Contact: Changcun Guo, MD 862984771539 guochc@fmmu.edu.cn

Locations
China, Shaanxi
Xijing Hospital of Digestive Disease, Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ying Han, Ph.D    86-29-84771539    hanying@fmmu.edu.cn   
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases

Responsible Party: Han Ying, Consultant Physician, Professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT03209986     History of Changes
Other Study ID Numbers: XJMSC0001
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Han Ying, Xijing Hospital of Digestive Diseases:
Liver Cirrhosis
Mesenchymal Sem Cells

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases