Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation - Full Text View

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

This study is currently recruiting participants.

Verified by Dresden University of Technology, March 2007

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00450268

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

U.S. FDA Resources

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

Further study details as provided by Dresden University of Technology:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Dresden University of Technology

Investigators

Principal Investigator:

Susanne Gretzinger, MD

Universität Carl Gustav Carus Med Klinik I

More Information

Study ID Numbers:	EK208122001
Study First Received:	March 21, 2007
Last Updated:	March 21, 2007
ClinicalTrials.gov Identifier:	NCT00450268
Health Authority:	Germany: Ethics Commission

Keywords provided by Dresden University of Technology:

Graft versus host disease
Allogeneic hematpoietic stem cell transplantation

Study placed in the following topic categories:

Graft versus host disease
Graft vs Host Disease
Homologous wasting disease

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009