Allogene MSCs Transplantation in Patients With Chronic Li... | NCT01256125

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

NCT01256125

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Dec 8, 2010Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Allogene MSCs Transplantation
Chronic Liver Diseases Patients
Peripheral Vein

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 7, 2010

First Submission Date that Met QC Criteria

Dec 7, 2010

First Posted Date

Dec 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2010

Last Update Posted Date

Dec 8, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Short-term therapeutic effects at 1-8 weeks after Allogene MSCs transplantation through peripheral vein.		1-8 weeks after transplantation

Secondary Outcomes

Measure	Description	Time Frame
Long-term follow-up of Allogene MSCs transplantation through peripheral vein.		3-60 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

pregnant women and women in lactation.
other systems and organs disfunction
space-occupying lesion were found in liver.
concurrent infection with HIV and other immunodeficiency diseases.
DIC and active bleeding were confirmed.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510630	China