Photo courtesy of NHS
Cord blood donation
The expanded umbilical cord blood (UCB) product NiCord can provide benefits over standard UCB transplant, according to research published in Biology of Blood and Marrow Transplantation.
NiCord is a stand-alone graft derived from a single UCB unit that has been expanded in culture and enriched with stem and progenitor cells.
The study showed that patients transplanted with NiCord had shorter time to engraftment, a lower risk of infection, and shorter hospital stays than patients who received standard UCB transplants.
On the other hand, there was no significant difference between the transplant groups when it came to grade 2-4 acute graft-versus-host disease (GVHD), relapse, or survival within 100 days of transplant.
“Our results indicate that rapid hematopoietic recovery from Gamida Cell’s NiCord transplantation approach is associated with clinical benefit,” said study author Mitchell Horwitz, MD, of Duke University School of Medicine in Durham, North Carolina.
Dr Horwitz receives research support from Gamida Cell Ltd., makers of NiCord.
Patient characteristics
The researchers compared 18 consecutive NiCord-transplanted patients and 86 consecutive patients who received standard UCB transplants. All of the patients received total body irradiation-based myeloablative conditioning.
In both arms, most patients received a double transplant. In the NiCord arm, 61.1% of patients (n=11) received NiCord along with a second unmanipulated UCB unit. In the standard UCB arm, 95.3% of patients (n=82) received a double UCB transplant.
Patients in the NiCord arm were older than patients in the standard UCB arm, with median ages of 45.5 (range, 42-57) and 37.5 (range, 28-51), respectively.
Most patients in both arms had acute leukemia or myelodysplastic syndromes (about 89%), although roughly 11% had lymphoid malignancies.
There were no significant differences between the arms when it came to patient sex, pre-transplant weight, cytomegalovirus serostatus, and Karnofsky Performance Status.
Results
The median time to neutrophil engraftment was 12.5 days (range, 10-18) in the NiCord arm and 27 days (range, 23-28) in the standard UCB arm (P<0.001).
All of the patients studied had at least 1 infection of any severity. However, patients in the NiCord arm had a significantly lower risk of infection than patients in the standard UCB arm.
In an analysis adjusted for age, disease stage, and grade 2-4 acute GVHD, the risk ratios (RRs) for NiCord versus standard UCB transplant were as follows:
- Total infection—RR=0.72, P=0.03
- Grade 2-3 infection—RR=0.38, P=0.001
- Bacterial infection—RR=0.42, P=0.008
- Grade 2-3 bacterial infection—RR=0.23, P=0.006.
Patients in the NiCord arm spent a mean of 72.4 days out of the hospital in the first 100 days after transplant, compared to 48.6 days for the standard UCB arm (P=0.001).
After the researchers adjusted for age and Karnofsky Performance Status, patients in the NiCord arm had a mean of 20.2 more days out of the hospital than their peers who received standard UCB (P=0.005).
The incidence of grade 2-4 acute GHVD was 55.6% in the NiCord arm and 41.9% in the standard UCB arm (P=0.31). The rate of second transplant was 5.6% and 11.6%, respectively (P=0.68).
The rate of relapse was 0% in the NiCord arm and 7% in the standard UCB arm (P=0.59). And the rate of death was 5.6% and 16.3%, respectively (P=0.46).
