Combination of Autologous MSC and HSC Infusion in Patients With Decompensated Cirrhosis

October 20, 2020 updated by: Asian Institute of Gastroenterology, India

Combination of Autologous Mesenchymal and Hematopoietic Stem Cell Infusion in Patients With Decompensated Cirrhosis: A Pilot Study

Though the results of autologous CD34+ cell infusion and MSC in independent studies have shown promise, yet they are yet to reach the desired long term outcome. The possible postulation for this is possibly because when using autologous CD34+ cell infusion, the inflammatory milieu of the liver may not be conducive for sustained effects of the mobilized CD 34+ cells. MSC have immunomodulatory effect (ref) and may improve the liver environment making it more beneficial for the CD34+ cells to function and survive. In addition, MSC has ben shown to produce hepatocyte growth factor which is protective against liver injury and beneficial for liver regeneration (shown in above tables). However, it remains to be understood how MSCs promote liver stem stem cells to differentiate into hepatocytes or expand the residual hepatocyte population. MSC can also directly inhibit the activation of hepatic stellate cells, the main source of extracellular matrix via MSC derived IL 10 and TNF-αand may also induce hepatic stellate cell apoptosis. Current lacunae in cell based therapy is based on the poor consensus and understanding on the best type of cells to be used, the ideal number of cells, the most appropriate route of administration and the need for repeat dosing . The concept that combination of autologous hematopoietic and mesenchymal stem cells infusion may be more beneficial than infusing any one of them alone has been discussed in many scientific forums but there are no study till date to either see the safety as well as the efficacy of this proof of concept .

With this above background data, we propose a study design which will be a safety study for combination use of autologous CD34+ and MSC

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500032
        • Asian institute of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 20-70 years
  • Clinically diagnosed for hepatic cirrhosis having a Child Pugh score of B or MELD >10 but below 20
  • Not willing for immediate liver transplantation either due to lack of donor tissue or financial issues
  • Platelet count of > 80,000 and INR <1.6
  • Life expectancy of at least 3 months based on MELD score and Child Pugh Score
  • Ability to give informed consent

Exclusion Criteria:

  • Age less than 20 or more than 70 years
  • Have liver tumors or history of any other cancer
  • Pregnant or lactating women
  • Patients with hepato-renal syndrome and acute kidney injury (Any creatinine > 1.6 will be excluded)
  • Evidence of ongoing sepsis - as per Surviving sepsis guideline
  • Recent gastrointestinal bleeding or spontaneous bacterial peritonitis (within last one month)
  • Any HIV positive patients
  • Co-morbid conditions such as severe cardiac and/or pulmonary disease
  • Inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Combination MSC and HSC
Patient will receive a combination of mesenchymal and Hematopoetic stem cell through hepatic artery under fluroscopic guidance
Combination product: CD 34 and MSC infusion
Combination of stem cells
Other Names:
  • Stem cell infusion
ACTIVE_COMPARATOR: Standard of care for Cirrhosis management
Diuretics, Hepatoprotective agents and Lactulose
Drug: Standard of care for Cirrhosis management
Drugs used for Cirrhosis management such as Diuretics, Hepatoprotective agents and Lactulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the safety of combination of hematopoetic and mesenchymal stem cell in patients of liver cirrhosis.
Time Frame: Up to 6 months

Any adverse events after the use of combination stem cell treatment would be recorded:

  • Bone marrow aspiration related complications such as pain (>6 on VAS) and bleeding from the site.
  • Leukapheresis related complications such as hypotension and hypocalcemia.
  • Hepatic artery catheterization related complications such as pain or discomfort at the catheter insertion site, bleeding and infection.
  • Post MSC and CD34 infusion related adverse reactions would be recorded using CDSCO form.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in MELD (Model for End stage Liver disease) score.
Time Frame: Up to 6 months
Difference in MELD score from baseline to follow-up period.
Up to 6 months
Change in Child Pugh score.
Time Frame: Up to 6 months
Difference in Child Pugh score from baseline to follow-up period.
Up to 6 months
Change in the percentage of CD 34 cells in liver.
Time Frame: Up to 6 months
To assess improvement in the percentage of CD 34 cells in liver by performing a paired liver biopsy- before and after infusion.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

August 1, 2020

Study Completion (ACTUAL)

September 1, 2020

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

January 24, 2020

First Posted (ACTUAL)

January 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECR/346/Inst/AP/2013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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