search
Back to results

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

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
ADSCs
Sponsored by
Gwo Xi Stem Cell Applied Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University Beigang Hospital
  • Gwo Xi Stem Cell Applied Technology Co., Ltd.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADSCs

Arm Description

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

Outcomes

Primary Outcome Measures

MELD
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.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2014
Last Updated
April 15, 2018
Sponsor
Gwo Xi Stem Cell Applied Technology Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02297867
Brief Title
Clinical Trial Study About Human Adipose-Derived Stem Cells in the Liver Cirrhosis
Official Title
Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 13, 2015 (Actual)
Primary Completion Date
December 18, 2017 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gwo Xi Stem Cell Applied Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.
Detailed Description
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADSCs
Arm Type
Experimental
Arm Description
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
Intervention Type
Drug
Intervention Name(s)
ADSCs
Other Intervention Name(s)
hADSCs
Intervention Description
autologous ADSCs
Primary Outcome Measure Information:
Title
MELD
Description
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.
Time Frame
1-6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Liver cirrhosis investigators with age 20 to 80 years (both inclusive). Investigators without Mandatory Communicable Disease (HBV, HCV, HIV, syphilis) Investigators without rare disorder Coagulation normalities Investigators without autoimmune disorder Investigators without Acquired Immune Deficiency Syndrome Investigators without cancer Investigators BMI > 15 Exclusion Criteria: Pregnant women Investigators with acute stroke in one month and unconsciousness Investigators with acute myocardial infarction or acute heart failure Investigators with serious liver dysfunction and coagulation dysfunction and ascites mild higher Investigators with acute respiratory failure or pneumonia Kidney Failure: BUN > 50 Anemia: Hematocrit < 25 Investigators diagnosed with liver cancer or liver metastatic carcinoma Investigators with liver abscess Investigators with acute Hepatitis Investigators with acute infective Liver cirrhosis patients with HBV or HCV Investigators diagnosed with carcinoma and receiving treatment Investigators with Schizophrenia or melancholia Investigators received serious surgical operations in 3 months Investigators unable to control hypertension (SBP > 180 mmHg, DBP > 110 mmHg) or diabetes (AC sugar > 200 mg/dl) Others can't fit into the trial evaluate by investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CMU B Hospital
Organizational Affiliation
China Medical University Beigang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University Beigang Hospital
City
Taichung
State/Province
Beigang
ZIP/Postal Code
65152
Country
Taiwan
Facility Name
Gwo Xi Stem Cell Applied Technology Co., Ltd.
City
Hsinchu
ZIP/Postal Code
30261
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
CRO
Citations:
PubMed Identifier
22776464
Citation
Harn HJ, Lin SZ, Hung SH, Subeq YM, Li YS, Syu WS, Ding DC, Lee RP, Hsieh DK, Lin PC, Chiou TW. Adipose-derived stem cells can abrogate chemical-induced liver fibrosis and facilitate recovery of liver function. Cell Transplant. 2012;21(12):2753-64. doi: 10.3727/096368912X652959. Epub 2012 Jul 5.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs