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

Chromosome Aberrations Clinical Trial

Official title:

Multi Centre Controlled Study on the Impact of Stem Cell Donation Either After Mobilisation With Granulocyte Colony Stimulating Factor or Bone Marrow Harvest on Unrelated Bone Marrow Donors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884610
• Other study ID #: BRD/06/143
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: June 19, 2013
• Start date: September 2008
• Est. completion date: June 2013

Study information

• Verified date: May 2013
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

Description:

The aim of this study is to detect any genetic differences between bone marrow and PBSC unrelated donors, post donation and confirm or refute the observations of "long-term genetic or epigenetic effects" published by Nagler et al[Nagler,A. et al. Exp.Haem (2004) 32;122-30]. The employment of more sensitive methods such as iFISH and gene array analysis to assess any permanent genetic changes, our primary objective, will make our study more robust.

There will be two arms:

i) Retrospective arm - the peripheral blood of unrelated donors who donated 3 to 5 years previously will be screened.

ii) Prospective arm - peripheral blood of unrelated donors will be examined prior to donation and at 120 and 360 day's post-donation. In those found to have aneuploid changes at these time points, there will be additional sampling at 24 and 36 months and if necessary these donors will be followed up.

Each arm of the study will include 50 BM unrelated donors and 50 PBSC unrelated donors giving a total sample population of around 200 unrelated donors. There will be one positive control group of 50 patients with a range of haematological malignancies. The blood samples taken from both BM and PBSC donors prior to donation will act as internal negative controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Donors of peripheral blood stem cells

Exclusion Criteria:

Relatives suffering from blood cancer

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chromosome Aberrations
• Chromosome Disorders

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	Anthony Nolan Research Institute, British Bone Marrow Registry

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chromosome aberration in peripheral blood lymphocytes	Peripheral blood stem cells donors who have been administered GCSF are monitored for genetic damage. This is performed by screening samples of peripheral blood lymphocytes taken before and after GCSF administration (at day 0, day 90 and day 180) for chromosome aberrations using FISH (fluorescence in situ hybridisation) methodology.	180 days	Yes