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NCT02829216 Clinical Trial

Graft-versus-host Disease Associated Myelosuppression

Graft vs Host Disease Clinical Trial

Official title:
Functional Profiling of the Hematopoietic Stem Cell Niche in Graft Versus Host Disease Mediated Bone Marrow Insufficiency

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02829216
Other study ID # Bone marrow GvHD
Secondary ID
Status Recruiting
Phase N/A
First received May 17, 2016
Last updated July 7, 2016
Start date April 2016

Study information
Verified date July 2016
Source Technische Universität Dresden
Contact Malte von Bonin, MD
Phone 00493514586636
Email malte.bonin@uniklinikum-dresden.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

The objective is to measure the frequency, functionality and phenotype of bone marrow-derived mesenchymal stromal cells in patients after allogeneic hematopoietic stem cell transplantation. Furthermore, the immune cell infiltrate of the bone marrow will be monitored at the same time. These results will be correlated with the extent of cytopenia and clinical graft-versus-host disease grading.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- age >18

- acute myeloid leukemia

- myelodysplastic syndrome

- hematopoietic stem cell transplantation

Exclusion Criteria:

- not willing to take part

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden Dresden

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in the amount of mesenchymal stromal cells after allogeneic hematopoietic stem cell transplantation up to 1 year after allogeneic hematopoietic stem cell transplantation No
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