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Allogene MSCs Transplantation in Patients With Chronic Liver Diseases Through Peripheral Vein.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01256125
First received: December 7, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

Allogene MSCs transplantation will be performed in patients with chronic liver diseases through peripheral vein and therapeutic effects including short-term effects and long-term follow-up will be compared and investigated.


Condition
Allogene MSCs Transplantation
Chronic Liver Diseases Patients
Peripheral Vein

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Therapeutic Effects of Allogene MSCs Transplantation in Patients With Chronic Liver Diseases Through Peripheral Vein.

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Short-term therapeutic effects at 1-8 weeks after Allogene MSCs transplantation through peripheral vein. [ Time Frame: 1-8 weeks after transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Long-term follow-up of Allogene MSCs transplantation through peripheral vein. [ Time Frame: 3-60 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2010
Groups/Cohorts
Allogene MSCs transplantation
Allogene MSCs transplantation were performed in patients with chronic liver diseases through peripheral vein plus the same medical treatments.
control
only medical treatments were performed in patients with chronic liver diseases.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chronic liver diseases including: viral hepatitis, alcoholic liver disease, autoimmune liver disease and so on.

Criteria

Inclusion Criteria:

  1. chronic liver diseases including: viral hepatitis, alcoholic liver disease, autoimmune liver disease.
  2. age: 15-65 years old.

Exclusion Criteria:

  1. pregnant women and women in lactation.
  2. other systems and organs disfunction
  3. space-occupying lesion were found in liver.
  4. concurrent infection with HIV and other immunodeficiency diseases.
  5. DIC and active bleeding were confirmed.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256125

Locations
China, Guangdong
Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University Recruiting
GuangZhou, Guangdong, China, 510630
Contact: Liang Peng, Dr.     +86-013533978874     pzp33@hotmail.com    
Contact: Jing Liu, Master     +86-013556051920     diudiu1203@163.com    
Sponsors and Collaborators
Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Zhi-liang Gao, 3rd Affiliated Hospital of Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01256125     History of Changes
Other Study ID Numbers: SunYat-sen U 11-5-1
Study First Received: December 7, 2010
Last Updated: December 7, 2010
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
allogene MSCs
transplantation
chronic liver diseases
peripheral vein

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013