Hepatic Artery Infusion of CD34+ Cells

Status Withdrawn

Clinical Trial Summary

The primary objective is to determine whether donor stem cells administered via hepatic artery infusion can produce liver cells in patients with severe hepatic dysfunction post stem cell transplantation (SCT) and the safety of this procedure. The secondary objective is to improve liver function and improve survival.

Clinical Trial Description

Participants in this study have received stem cell transplantation. As a result of this procedure, participants have developed severe liver dysfunction. Researchers have recently discovered that cells circulating in the blood and bone marrow are capable of forming liver cells. Before taking part in this study, women able to have children must have a negative blood pregnancy test.

Participants in this study will have donor's cells infused directly into their liver through a catheter that will be inserted through the groin. This will be done after liver disease has been diagnosed by liver biopsy. The catheter will stay in the groin for no more than 3 days. During that time, participants will be exposed to repeated x-ray exams to ensure that the catheter stays in place.

During the time that the catheter is in place, the infusion will be repeated as long as donor's cells are available. Participants will receive different drugs by vein to decrease the risk of transfusion reaction. After completing donor cell infusion, the catheter will be removed.

After participants are released from the hospital, they will have periodic evaluation of liver size. About 1 teaspoon of blood will be drawn for standard blood tests to evaluate liver function. Around Days 28 and 90, participants will have liver biopsy.

This is an investigational study. A total of 10 patients will take part in this study. All will be enrolled at UTMDACC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00062543
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Withdrawn
Phase	Phase 1
Start date	May 2002
Completion date	October 2005

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05255042` - Tissue Models for Liver Disease
Completed	`NCT04473482` - Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial	N/A
Not yet recruiting	`NCT05120557` - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH	N/A
Completed	`NCT02917408` - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Recruiting	`NCT03773887` - Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease	N/A
Recruiting	`NCT00345930` - DILIN - Prospective Study
Completed	`NCT00148031` - Improving Hepatitis C Treatment in Injection Drug Users	Phase 4
Terminated	`NCT00031135` - Total Parenteral Nutrition-Associated Liver Disease	Phase 2
Completed	`NCT00005305` - Hepatitis Delta Infections in Hemophiliacs	N/A
Completed	`NCT00005304` - Delta Hepatitis and Liver Disease in Hemophiliacs
Completed	`NCT00222664` - Qidong Hepatitis B Intervention Study	Phase 4
Recruiting	`NCT06195917` - Robotic-assisted Percutaneous Transhepatic Puncture	N/A
Recruiting	`NCT04551742` - Social & Contextual Impact on Children Undergoing Liver Transplantation
Completed	`NCT04782050` - Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation	N/A
Completed	`NCT03614039` - Effect of Probiotic and Smectite Gel on NAFLD	N/A
Recruiting	`NCT04518852` - TACE, Sorafenib and PD-1 Monoclonal Antibody in the Treatment of HCC	Phase 2
Recruiting	`NCT05499585` - Treating Pediatric NAFLD With Nutrition	N/A
Terminated	`NCT03396705` - Liver Regeneration
Completed	`NCT04341012` - Breath Analysis Based Disease Biomarkers of COVID-19 and Other Diseases
Recruiting	`NCT05733832` - A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease	N/A