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Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation (DCalloTX)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Technische Universität Dresden.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00450268
First Posted: March 22, 2007
Last Update Posted: March 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität Dresden
  Purpose
We plan to investigate prospectively and simultaneously skin and blood DC subtypes, their donor/recipient origin and the correlation of DC reconstitution kinetics with treatment, clinical outcome and incidence of aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation.

Condition Intervention
Graft Versus Host Disease Procedure: blood draw, skin shave biopsy

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Analysis of Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Estimated Enrollment: 50
Study Start Date: January 2005
Estimated Study Completion Date: January 2010
Detailed Description:
Blood and skin DC reconstitution shall be investigated in patients affected by hematological diseases and receiving HLA-matched, mobilized peripheral blood stem cells from related or unrelated donors. We plan to simultaneously collect and process double biopsies, i.e. from graft versus host disease affected and non-lesional skin of patients at onset of acute graft versus host disease following allogeneic hematopoietic stem cell transplantation. Emigration assay, Chimerism analysis and immunohistochemistry will be performed.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient undergoing an allogeneic hematopoietic stem cell transplantation
  • Older than 18 years
  • WHO-Performance-Status 0 to3
  • Informed consent
  • Graft versus host disease of the skin

Exclusion Criteria:

  • Clotting parameters more than double of normal
  • Infection of the skin
  • Leucocytes < 1000/µl; Thrombocytes < 20 000/µl
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450268


Contacts
Contact: Susanne Gretzinger, MD +49 351 458 ext 2583 susanne.gretzinger@uniklinik-dresden.de
Contact: Martin Bornhäuser, Professor *49 351 458 ext 4190 martin.bormhaeuser@uniklinik-dresden.de

Locations
Germany
Universitätsklinik Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Contact: Susanne Gretzinger, MD    +49 351 458 ext 2583    susanne.gretzinger@uniklinik-dresden.de   
Contact: Martin Bornhaeuser, MD    +49 351 458 ext 4190    Martin.Bornhaeuser@uniklinik-dresden.de   
Principal Investigator: Susanne Gretzinger, MD         
Principal Investigator: Martin Bornhaeuser, Prof         
Principal Investigator: Christian Thiede, Prof         
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Susanne Gretzinger, MD Universität Carl Gustav Carus Med Klinik I
  More Information

ClinicalTrials.gov Identifier: NCT00450268     History of Changes
Other Study ID Numbers: EK208122001
First Submitted: March 21, 2007
First Posted: March 22, 2007
Last Update Posted: March 22, 2007
Last Verified: March 2007

Keywords provided by Technische Universität Dresden:
Graft versus host disease
Allogeneic hematpoietic stem cell transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases