Hepatic Artery Infusion of CD34+ Cells

Liver Diseases Clinical Trial

Official title:

Hepatic Artery Infusion of CD34+ Cells, Isolated by the Isolex 300i Device, in Stem Cell Transplant Recipients With Hepatic Failure Due to Veno-occlusive Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00062543
• Other study ID #: ID02-167
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 2002
• Est. completion date: October 2005

Study information

• Verified date: October 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• SCT recipients with severe hepatic dysfunction (bilirubin equal to or greater than 5mg/dl) and histologically documented VOD.

• The original stem cell donor must be sex-mismatched, willing and able to donate G-CSF-mobilized peripheral blood stem cells.

• The patient must have complete donor chimerism.

Exclusion Criteria:

• Patients who do not have at least 5 x 10^6 donor CD34+ cells/kg available for infusion.

• Patients with graft versus host disease (GVHD).

• Patients in whom hepatic artery infusion cannot be performed because of anatomical or technical reasons.

• Patients with active hepatitis B or C.

Related Conditions & MeSH terms

• Liver Diseases
• Stem Cell Transplantation

Intervention

Procedure:
• Hepatic artery infusion of CD34+ cells
Donor's cells infused directly into liver through a groin catheter (hepatic artery).

Device:
• Cobe Spectra
Mononuclear cells (MNC) collected by continuous-flow centrifugation using a blood cell separator (Cobe Spectra).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Learn if donor's cells can produce liver cells when injected directly into the liver and whether this procedure will improve liver function and survival.		3 Years

External Links

•   UT MD Anderson Cancer Center website