Intrabone Injection of Unrelated Cord-Blood Cells Prevents Graft Failure, Aids Haemopoietic Recovery
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Intrabone Injection of Unrelated Cord-Blood Cells Prevents Graft Failure, Aids Haemopoietic Recovery

NEW YORK -- August 11, 2008 -- Intrabone administration of unrelated umbilical cord-blood cells prevents graft failure and is associated with a low incidence of graft-versus-host disease in patients with acute leukaemia, according to a phase 1/2 study published early online and in the September edition of The Lancet Oncology.

Francesco Frassoni, MD, San Martino Hospital, Genoa, Italy, and colleagues investigated intrabone injection of cord-blood cells as an alternative to intravenous injection in order to assess whether this new approach was able to ensure engraftment and shorten the time to complete haemopoietic recovery.

Between March 2006 and January 2008, the safety and efficacy of intrabone injection were assessed in 32 patients with acute myeloid leukaemia or acute lymphoblastic leukaemia.

A suitable unrelated cord-blood unit was found for each patient, and human leucocyte antigen matching was 5/6 for 9 patients, 4/6 for 22 patients, and 3/6 for 1 patient. The cord-blood cells were concentrated in 5-mL syringes and were injected into the superior-posterior iliac crest under rapid general anaesthesia.

The primary endpoint was the probability of neutrophil and platelet recovery, and secondary endpoints were the incidence of graft-versus-host disease, relapse, and overall survival.

Of 28 assessable patients, all achieved complete neutrophil recovery, with a median time to recovery of 23 days (range 14-44 days) and 27 patients achieved complete platelet recovery within a median time of 36 days (range 16-64 days).

All 27 patients showed complete reconstitution of haemopoiesis from cord-blood cells, and none had secondary graft failure. Furthermore, no patients developed grade III-IV acute graft-versus-host disease. Overall survival was 45% at 1 year, with a median follow-up of 13 months (range 3-23 months).

"This technique might be possible in a large number of adult patients. The decreased incidence of acute graft-versus-host disease is intriguing. If these findings are proven in a larger series of patients, direct intrabone injection will have the potential to affect the current practice of haemopoietic stem-cell transplantation," said Dr. Frassoni.

SOURCE: The Lancet Oncology

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