Hepatocyte Transplantation in Liver Failure | NCT00805610

Studies
Hepatocyte Transplantation in Liver Failure

NCT00805610

Sponsor

Virginia Commonwealth University

Status

Withdrawn

Last Update Posted

Aug 5, 2014Estimated

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Liver Failure

Interventions

Hepatocyte Transplantation

Countries

United States

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

Aug 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator taking position at another university-0 enrolled under this protocol.

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Jun 2016Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Dec 5, 2008

First Submission Date that Met QC Criteria

Dec 8, 2008

First Posted Date

Dec 9, 2008Estimated

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

Aug 1, 2014

Last Update Posted Date

Aug 5, 2014Estimated

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

The investigators research will examine the safety and efficacy of hepatocyte transplantation in the patient with acute liver failure without history of chronic disease. The investigators will study the effectiveness in providing a bridge of support for patient survival until whole organ transplantation is possible. This support may also be a bridge to recovery; by allowing the native liver to recover so that orthotopic liver transplant is not necessary.

The investigators will also study the safety and efficacy of hepatocyte transplantation in the patient with chronic liver disease. Underlying etiologies of chronic disease may arise from cirrhosis, fibrosis or inherited metabolic disorders. The investigators will examine cell transplantation in end-stage patients not eligible for whole organ transplant. These patients may benefit with an amelioration of symptoms that will allow other therapeutic treatments.

The investigators study will also examine the ability of transplanted hepatocytes to treat inherited metabolic diseases (ex., Crigler-Najjar Disease, Familial Hypercholesterolemia, Urea Cycle Disorders). Cell transplant may also act as a 'bridge' to whole organ transplant or improve function, permitting easier disease control through traditional therapy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hepatocyte Transplantation	Experimental	Hepatocyte Transplantation through single donor will be transplanted into the liver via intraportal or intrasplenic routes.	Biological: Hepatocyte Transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hepatocyte Transplantation	Biological	Briefly, prepared hepatocytes from a single donor will be transplanted into the liver via intraportal or intrasplenic routes.	Hepatocyte Transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The functional capability of transplanted hepatocytes to assume function in the native liver.		Outcome measurements will be assessed weekly through week two post transplant, then monthly through month 12, then every six months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion criteria are specific to the classification of liver disease, i.e., fulminant or non-fulminant or metabolic disease

Exclusion Criteria:

Any systemic infection
Unstable coronary artery disease
HIV infection
Preformed antibodies to class antigens that are present on all available donor samples (Only cells from an ABO-compatible donor with no HLA Class I antigen to which the recipient has preformed antibodies will be selected for transplant.)
Hepatopulmonary disease (Room air Pa02 ≤ 60 mmHg)
Testing positive for Hepatitis B Surface Antigen (HBsAg), Hepatitis Be antigen (HBeAg) or Hepatitis B Virus by DNA and unable to receive or pay for Hepatitis B treatment.
Any current or anticipated contraindication for the use of tacrolimus and cyclosporine, methylprednisolone or prednisone.
Female patients who are breast feeding
Any medical condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert A Fisher, M.D.	Virginia Commonwealth University Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University Health System		Richmond	Virginia	23298	United States

Condition Browse Module

MeSH Terms

ID	Term
D017093	Liver Failure

Ancestor Terms

ID	Term
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases

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