Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation

NCT ID: NCT00450268

Last Updated: 2007-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Graft Versus Host Disease

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Interventions

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blood draw, skin shave biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Principal Investigators

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Susanne Gretzinger, MD

Role: PRINCIPAL_INVESTIGATOR

Universität Carl Gustav Carus Med Klinik I

Locations

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Universitätsklinik Carl Gustav Carus

Dresden, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Susanne Gretzinger, MD

Role: CONTACT

+49 351 458 ext. 2583

Martin Bornhäuser, Professor

Role: CONTACT

*49 351 458 ext. 4190

Facility Contacts

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Susanne Gretzinger, MD

Role: primary

+49 351 458 ext. 2583

Martin Bornhaeuser, MD

Role: backup

+49 351 458 ext. 4190

Other Identifiers

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EK208122001

Identifier Type: -

Identifier Source: org_study_id

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