NCT02829216

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

May 17, 2016

Last Update Submit

July 7, 2016

Conditions

Abnormal HematopoiesisAllogenic DiseaseGraft vs Host Disease

Keywords

myelosuppressionmesenchymal stromal cells

Outcome Measures

Primary Outcomes (1)

  • Changes in the amount of mesenchymal stromal cells after allogeneic hematopoietic stem cell transplantation

    up to 1 year after allogeneic hematopoietic stem cell transplantation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with AML/MDS receiving an allogeneic hematopoietic stem cell transplantation

You may qualify if:

  • age \>18
  • acute myeloid leukemia
  • myelodysplastic syndrome
  • hematopoietic stem cell transplantation

You may not qualify if:

  • not willing to take part

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden

Dresden, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Malte von Bonin, MD

    Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Malte von Bonin, MD

CONTACT

00493514586636malte.bonin@uniklinikum-dresden.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

July 12, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Last Updated

July 12, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)