Saturday, August 9, 2008

[StemCells] Leukemia: Intrabone transplants

Good Results Seen with Intrabone Cord Blood Transplant for Leukemia
By John Gever, Staff Writer, MedPage Today
Published: August 08, 2008
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine. Earn CME/CE credit
for reading medical news


GENOA, Italy, Aug. 8 -- Leukemia patients who had umbilical cord
blood cells from unrelated donors injected into their bone showed
excellent levels of engraftment and low rates of graft-versus-host
disease, researchers here said. Action Points
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Explain to interested patients that the study found that cord blood
transplant directly into the bone marrow space gave good results in
acute leukemia.

Explain that the technique remains investigational pending larger and
longer-term studies to confirm the favorable results.
In a 32-patient phase I/II trial involving partially HLA-matched,
intrabone cord blood cells for treating acute lymphoblastic or acute
myeloid leukemia, peripheral lymphocytes and marrow were fully
chimeric after 30 days and remained so throughout follow-up in all
cases, reported Francesco Frassoni, M.D., of San Martino Hospital,
and colleagues online in Lancet Oncology.

Moreover, no cases of grade 3 or 4 acute graft-versus-host disease
developed, the researchers said.

They said the approach could be practice-changing if larger studies
show similar results. "This technique might be possible in a large
number of adult patients," they wrote.

Past efforts to treat leukemia with intravenous cord blood
transplants, rather than with marrow or peripheral blood stem cells,
have not been very successful, the researchers said, with graft
failure rates of 10% to 20%.

"We postulated that direct intrabone transplantation of cord-blood
cells could improve hematological recovery as a result of better stem-
cell homing," they said.

Each participant in the study -- including 12 with lymphocytic and 20
with myeloid disease -- received one unit of cord blood from banks in
the U.S. and Europe.

Patients were included in the study if unrelated stem cell
transplantation was indicated and no suitable HLA-matched donor was
available. About half were in complete remission. The remainder had
advanced-stage refractory disease.

The cord blood had HLA matches of 5/6 in nine patients, 4/6 in 22
patients, and 3/6 in one patient.

It was injected into the pelvic bone with a standard marrow-
aspiration needle. After the first patient described unbearable pain
with local anesthesia, later procedures were done under propofol
sedation.

Patients also received granulocyte colony-stimulating factors to
promote neutrophil recovery, as well as prophylaxis against graft-
versus-host-disease with cyclosporine, mycophenolate mofetil, and
anti-thymocyte globulin.

With up to two years of follow-up (median 13 months), 16 patients
survived in hematological remission. The overall survival rate one
year after transplant was 45% (95% CI 36% to 54%).

Four patients, all with advanced disease, died within 12 days of
transplant, and another died on day 30 before achieving platelet
recovery.

In the remaining patients, median time to neutrophil recovery was 23
days (range 14 to 44). Platelet recovery occurred in a median of 36
days (range 16 to 64).

Grade 1 acute graft-versus-host-disease was seen in two patients and
it developed at grade 2 in four patients. Five developed chronic
disease, moderate in four and extensive in one.

Causes of death included infections in seven patients, relapsed
leukemia in four, and multi-organ failure in four.

Dr. Frassoni and colleagues said they had two concerns going into the
study -- that intrabone delivery of cord blood would not speed up
engraftment, and that stem cells would not home as expected.

Both worries were allayed by the study results, they said.

"Our data suggest this new route of administration could be
effective," they wrote. "Nevertheless, our findings will need
confirmation in larger studies with longer follow-up."

The researchers acknowledged that the procedure, which must take
place in an operating room, is more complicated than a conventional
intravenous transplant.

Dr. Frassoni said other approaches to improving engraftment of cord
blood transplants had shown promise as well, such as doubling the
quantity of cord blood used.

The study was funded by the Associazione Italiana Ricerca contro il
Cancro, Compagnia di San Paolo Torino, Progetto CARIGE Cellule
Staminali, the EUROCORD III, Ministero della Salute, and the
Associazione Italiana Leucemie, Sezione Ligure.
No potential conflicts of interest were reported.

Primary source: Lancet Oncology
Source reference:
Frassoni F, et al "Direct intrabone transplant of unrelated cord-
blood cells in acute leukemia: a phase I/II study" Lancet Oncology
2008; DOI: 10.1016/S1470-2045(08)70180-3.

Additional Leukemia Coverage

http://www.medpagetoday.com/HematologyOncology/Leukemia/tb/10495

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StemCells subscribers may also be interested in these sites:

Children's Neurobiological Solutions
http://www.CNSfoundation.org/

Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123

The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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