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NCT00450268 Clinical Trial

Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation

Graft Versus Host Disease Clinical Trial

— DCalloTX  

Official title:
Analysis of Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00450268
Other study ID # EK208122001
Secondary ID
Status Recruiting
Phase N/A
First received March 21, 2007
Last updated March 21, 2007
Start date January 2005
Est. completion date January 2010

Study information
Verified date March 2007
Source Technische Universität Dresden
Contact Susanne Gretzinger, MD
Phone +49 351 458
Email susanne.gretzinger@uniklinik-dresden.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date January 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Procedure:
• blood draw, skin shave biopsy

Locations
Country Name City State
Germany Universitätsklinik Carl Gustav Carus Dresden

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

See also
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