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Study on the Impact of Stem Cell Donation and Bone Marrow Harvesting on Unrelated Donors

NCT01884610 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2013-06-24

No results posted yet for this study

Summary

Granulocyte Colony Stimulating Factor (GCSF) is used extensively as a means of mobilising donor peripheral blood stem cells as an alternative to bone marrow harvesting for the purpose of recipient stem cell transplantation. The principal objective of the research is to study any longterm genetic effects of GCSF in the peripheral blood white cells of unrelated blood stem cell donors.

The study subjects will be Retrospective and Prospective voluntary unrelated donors on the Anthony Nolan Bone Marrow Registry being harvested at the Royal Free Hospital and University College Hospital, London and British Bone Marrow Registry donors harvested at the Royal Free Hospital and BUPA Glen Vale in Bristol.

All participants in the Prospective Arm will be asked to donate one 5-10ml sample of blood at study entry prior to stem cell donation and further samples at 120 and 360 days post donation. Those found to carry aneuploid cell clones at these time points will be asked for a further 5-10ml blood sample at least twice - at the end of 24 months and 36 months respectively. The Retrospective and Positive Control group will be asked to supply one 5-10ml sample of blood.

Conditions

  • Chromosome Aberrations

Sponsors & Collaborators

  • British Bone Marrow Registry

    collaborator UNKNOWN

  • Anthony Nolan Research Institute

    collaborator UNKNOWN

  • University College, London

    lead OTHER

Principal Investigators

  • Elisabeth P Nacheva, MD PhD FRCPath · University College London (UCL) Cancer Institute

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2013-06-30
Completion
2013-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01884610 on ClinicalTrials.gov