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

G

Gwo Xi Stem Cell Applied Technology

Status and phase

Completed
Phase 1

Conditions

Liver Cirrhosis

Treatments

Drug: ADSCs

Study type

Interventional

Funder types

Industry

Identifiers

NCT02297867
28113265

Details and patient eligibility

About

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

Full description

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

Enrollment

6 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

ADSCs
Experimental group
Description:
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
Treatment:
Drug: ADSCs

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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