Trial Information

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.

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.