- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00062543
Hepatic Artery Infusion of CD34+ Cells
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hepatic Artery Infusion
Donor-derived CD34+ cells administered in a total volume of 100ml via hepatic artery over 10 minutes.
Cells given as a dose escalation study.
First cohort of 3 patients receive 1 * 106 CD34+ cells/kg.
Next 3 patients receive 2.5 * 106 CD34+cells/kg.
Next 3 patients receive 5 * 106 CD34+ cells/kg.
Less than 1 * 105 T cells/kg administered.
|
Donor's cells infused directly into liver through a groin catheter (hepatic artery).
Mononuclear cells (MNC) collected by continuous-flow centrifugation using a blood cell separator (Cobe Spectra).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 3 Years
|
3 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zeev Estrov, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID02-167
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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