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

NCT ID: NCT02297867

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-13

Study Completion Date

2018-03-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cirrhosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ADSCs

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

Group Type EXPERIMENTAL

ADSCs

Intervention Type DRUG

autologous ADSCs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADSCs

autologous ADSCs

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

hADSCs

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gwo Xi Stem Cell Applied Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sabrina Huang

China Medical University Beigang Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

CMU B Hospital

Role: STUDY_DIRECTOR

China Medical University Beigang Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

China Medical University Beigang Hospital

Taichung, Beigang, Taiwan

Site Status

Gwo Xi Stem Cell Applied Technology Co., Ltd.

Hsinchu, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22776464 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

28113265

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mesenchymal Stem Cell Therapy for Liver Cirrhosis
NCT03626090 UNKNOWN PHASE1/PHASE2
Mesenchymal Stem Cells Treat Liver Cirrhosis
NCT01233102 SUSPENDED PHASE1/PHASE2