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

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ClinicalTrials.gov Identifier: NCT00450268
Recruitment Status : Unknown
Verified March 2007 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : March 22, 2007
Last Update Posted : March 22, 2007
Sponsor:
Information provided by:
Technische Universität Dresden

Brief Summary:
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 or disease Intervention/treatment
Graft Versus Host Disease Procedure: blood draw, skin shave biopsy

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.

Study Type : Observational
Enrollment : 50 participants
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
Study Start Date : January 2005
Estimated Study Completion Date : January 2010

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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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

ClinicalTrials.gov Identifier: NCT00450268     History of Changes
Other Study ID Numbers: EK208122001
First Posted: March 22, 2007    Key Record Dates
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