RIC UCBT

• Research type

  Research Study

• Full title

  Transplantation of umbilical cord blood (UCB) from unrelated donors (URD) in patients with haematological diseases using a reduced intensity conditioning regimen.

• Contact name

  Ed Blandford

• Sponsor organisation

  University College London

• Eudract number

  2004-003845-41

• ISRCTN Number

  Not submitted

• Research summary

  Umbilical cord blood transplantation is an effective therapy for treating patients with advanced or high risk haematological diseases who have no suitable related or unrelated blood or bone marrow donors. Doctors at the University of Minnesota, America have tried a new way of using cord stem cells to give a transplant which uses lower doses of the conditioning drugs and radiotherapy before stem cell infusion. They have also used stem cells from two different cord bloods if there are not enough cells in one cord. This new type of treatment has been shown to work well in adults but it has not yet been tried in children. This trial is using the approach developed by the University of Minnesota with a reduced intensity conditioning regimen, umbilical cord blood as the stem cell source and more than one unit of blood is used if one unit is not sufficient. The procedure used in this trial is not a new type treatment being tested, rather it is an established form of treatment being used in a group of patients for which there are no alternative treatment options. These patients will have exhausted all other conventional forms of treatment and this is the only treatment option available to them, without this treatment their prognosis is extremely poor. This trial aims to verify the safety and efficacy of the approach used by the doctors in Minnesota in the context of a multi-institution UK setting. It also aims to establish whether this type of transplant is effective in children as well as adults. In addition it aims to assess how well the immune system regenerates after transplantation and the risk that this group of patients will relapse during post-transplant follow-up.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  08/H0706/92

• Date of REC Opinion

  12 Jan 2009

• REC opinion

  Further Information Favourable Opinion