Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
NCT ID: NCT05106972
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-12-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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UC-MSC infusion
UC-MSC infusion by intravenus, 1\*10\^8 cells/dose, 2 doses (apart from 24weeks)
UC-MSC infusion
UC-MSC infusion by introvenus
Interventions
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UC-MSC infusion
UC-MSC infusion by introvenus
Eligibility Criteria
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Inclusion Criteria
* Diagnosed chronic decompensated hepatitis B cirrhosis with a course of more than 5 years
* Not suitable for liver transplantation or there is no donor liver source
* No serious bleeding tendency or active bleeding
* No hepatic encephalopathy
* After strict medical conservative treatment for more than 6 months, there was no relief of symptoms or significant improvement of quality of life score
* Subjects voluntarily participate in this study and sign informed consent
Exclusion Criteria
* Cirrhosis caused by other causes such as alcoholic hepatitis, hepatitis C virus and autoimmune hepatitis
* Found liver malignant tumor or the family history of liver malignant tumor in the third generation of their direct relatives
* Patients with hypersplenism who need splenectomy
* History of tumors in other organs
* PT prolongation is greater than 3 seconds
* Use of human serum albumin within 3 weeks prior to clinical registration
* Clinically significant upper gastrointestinal bleeding events occurred within 4 weeks before clinical registration
* Spontaneous peritonitis
* Active infection (viral or bacterial)
* Pregnant or lactating women
* The researcher considers it inappropriate to participate in this study
20 Years
60 Years
ALL
No
Sponsors
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Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Haikou People's Hospital
Haikou, , China
Countries
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Central Contacts
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Facility Contacts
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Xiaoxi Huang, PHD
Role: primary
Other Identifiers
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SCT20181032
Identifier Type: -
Identifier Source: org_study_id