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Hepatic Artery Infusion of CD34+ Cells



Hepatic Artery Infusion of CD34+ Cells

For Condition: Stem Cell Transplantation,Liver Diseases
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion: - 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: - 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.
Total Enrollment: 10

Location and Contact Information:

U.T.M.D. Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Margaret  O'Day 713-745-0132


Additional Information:
Study ID Numbers:
  ID02-167; 
Study Start Date: May 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062543

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