Clinical Trial Study About Human Adipose-Derived Stem Cells in the Liver Cirrhosis

April 15, 2018 updated by: Sabrina Huang, Gwo Xi Stem Cell Applied Technology Co., Ltd.

Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis

The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

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

  • Taiwan
      • Hsinchu, Taiwan, 30261
        • Gwo Xi Stem Cell Applied Technology Co., Ltd.
    • Beigang
      • Taichung, Beigang, Taiwan, 65152
        • China Medical University Beigang Hospital

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Liver cirrhosis investigators with age 20 to 80 years (both inclusive).
  2. Investigators without Mandatory Communicable Disease (HBV, HCV, HIV, syphilis)
  3. Investigators without rare disorder
  4. Coagulation normalities
  5. Investigators without autoimmune disorder
  6. Investigators without Acquired Immune Deficiency Syndrome
  7. Investigators without cancer
  8. Investigators BMI > 15

Exclusion Criteria:

  1. Pregnant women
  2. Investigators with acute stroke in one month and unconsciousness
  3. Investigators with acute myocardial infarction or acute heart failure
  4. Investigators with serious liver dysfunction and coagulation dysfunction and ascites mild higher
  5. Investigators with acute respiratory failure or pneumonia
  6. Kidney Failure: BUN > 50
  7. Anemia: Hematocrit < 25
  8. Investigators diagnosed with liver cancer or liver metastatic carcinoma
  9. Investigators with liver abscess
  10. Investigators with acute Hepatitis
  11. Investigators with acute infective
  12. Liver cirrhosis patients with HBV or HCV
  13. Investigators diagnosed with carcinoma and receiving treatment
  14. Investigators with Schizophrenia or melancholia
  15. Investigators received serious surgical operations in 3 months
  16. Investigators unable to control hypertension (SBP > 180 mmHg, DBP > 110 mmHg) or diabetes (AC sugar > 200 mg/dl)
  17. Others can't fit into the trial evaluate by investigator

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADSCs
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
Drug: ADSCs
autologous ADSCs
Other Names:
  • hADSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MELD
Time Frame: 1-6 month
MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. It is calculated according to the following formula:MELD = 3.78[Ln serum bilirubin (mg/dL)] + 11.2[Ln INR] + 9.57[Ln serum creatinine (mg/dL)] + 6.43.
1-6 month

Collaborators and Investigators

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

Sponsor

Gwo Xi Stem Cell Applied Technology Co., Ltd.

Investigators

  • Study Director: CMU B Hospital, China Medical University Beigang Hospital

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 13, 2015

Primary Completion (Actual)

December 18, 2017

Study Completion (Actual)

March 27, 2018

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 15, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28113265

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

CRO

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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