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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02297867 |
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Date of registration:
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19/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Trial Study About Human Adipose-Derived Stem Cells in the Liver Cirrhosis
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Scientific title:
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Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis |
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Date of first enrolment:
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July 13, 2015 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02297867 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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CMU B Hospital |
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Address:
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Telephone:
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Email:
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Affiliation:
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China Medical University Beigang Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Liver Cirrhosis
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Intervention(s)
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Drug: ADSCs
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Primary Outcome(s)
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MELD
[Time Frame: 1-6 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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