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Phase I Study of Umbilical Cord Blood Transplantation Followed by Third Party Thymus Transplantation

NCT00597441 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-04-01

No results posted yet for this study

Summary

The objective of this trial is to assess the toxicity of thymus transplantation following unrelated umbilical cord blood transplantation. Emphasis will be placed on adverse events that are not typically associated with umbilical cord blood transplantation. Also, to determine whether engraftment of a third party thymus allograft is feasible in patients who have undergone unrelated umbilical cord blood transplantation.

Conditions

  • Stem Cell Transplantation

Interventions

BIOLOGICAL

Thymic Transplantation for Recipients of UCB transplant

Subjects with hematologic malignancies or bone marrow failure disorders will undergo umbilical cord blood transplantation and two months post transplant will have thymic tissue from a third party donor transplanted into the thigh muscle.

Sponsors & Collaborators

  • Sumitomo Pharma Switzerland GmbH

    lead INDUSTRY

Principal Investigators

  • Mitchell Horwitz, MD · Duke Health

  • Mary L Markert, MD · Duke Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00597441 on ClinicalTrials.gov