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Expanded UCB product provides clinical benefit

Cord blood donation

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VALENCIA, SPAIN—The expanded umbilical cord blood (UCB) product NiCord can provide clinical benefits in patients with high-risk hematologic malignancies, according to data presented at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation.

NiCord consists of cells from a single UCB unit cultured in nicotinamide—a vitamin B derivative—and cytokines that are typically used for expansion—thrombopoietin, interleukin 6, FLT3 ligand, and stem cell factor.

The data showed that patients transplanted with NiCord had fewer moderate to severe bacterial infections and shorter hospital stays than patients who received standard UCB transplants.

“We saw a significant reduction in serious bacterial infections during the first 100 days in the NiCord group,” said Mitchell Horwitz, MD, of the Duke University School of Medicine in Durham, North Carolina.

“This is encouraging because this type of infection is a major cause of early death following UCB transplantation. We also saw a significant reduction in hospitalization time in the NiCord group, indicating a faster recovery of these patients in comparison to those transplanted with standard umbilical cord blood.”

These results were presented at the meeting as abstract O090. The research was funded by Gamida Cell, the company developing NiCord.

Dr Horwitz and his colleagues analyzed 18 patients with high-risk hematologic malignancies—most with acute leukemia or myelodysplastic syndromes (90%)—who were transplanted with NiCord.

Ten of the patients received NiCord with a second, unmanipulated UCB unit, and 8 patients received NiCord as a single UCB graft.

The researchers compared these patients to 101 patients who received standard single or double UCB transplants at Duke University from January 2005 to March 2015.

Patients in both groups received a total body irradiation-based myeloablative preparative regimen.

The median time to neutrophil engraftment was significantly shorter in the NiCord group than the control group—12.5 days and 27 days, respectively (P<0.001).

All 18 patients in the Nicord group and 100 patients in the control group had at least 1 infection.

Patients in the NiCord group had a significantly lower incidence of grade 2-3 bacterial infections than patients in the control group—22% and 54%, respectively (P=0.015).

However, there was no significant difference between the groups with regard to grade 2-3 viral infections (39% and 35%, respectively, P=0.729), fungal infections (0% and 5%, respectively, P=1.0), or non-microbiologically defined infections (0% and 17%, respectively, P=0.072).

In the first 100 days after transplant, patients in the NiCord group spent significantly more days out of the hospital than patients in the control group. The median number of days for each group was 74 and 53, respectively (P=0.002).

“These results demonstrate that the rapid hematopoietic recovery from NiCord transplantation results in clinical benefit, in comparison to similar site controls,” Dr Horwitz concluded.

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Cord blood donation

Photo courtesy of NHS

VALENCIA, SPAIN—The expanded umbilical cord blood (UCB) product NiCord can provide clinical benefits in patients with high-risk hematologic malignancies, according to data presented at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation.

NiCord consists of cells from a single UCB unit cultured in nicotinamide—a vitamin B derivative—and cytokines that are typically used for expansion—thrombopoietin, interleukin 6, FLT3 ligand, and stem cell factor.

The data showed that patients transplanted with NiCord had fewer moderate to severe bacterial infections and shorter hospital stays than patients who received standard UCB transplants.

“We saw a significant reduction in serious bacterial infections during the first 100 days in the NiCord group,” said Mitchell Horwitz, MD, of the Duke University School of Medicine in Durham, North Carolina.

“This is encouraging because this type of infection is a major cause of early death following UCB transplantation. We also saw a significant reduction in hospitalization time in the NiCord group, indicating a faster recovery of these patients in comparison to those transplanted with standard umbilical cord blood.”

These results were presented at the meeting as abstract O090. The research was funded by Gamida Cell, the company developing NiCord.

Dr Horwitz and his colleagues analyzed 18 patients with high-risk hematologic malignancies—most with acute leukemia or myelodysplastic syndromes (90%)—who were transplanted with NiCord.

Ten of the patients received NiCord with a second, unmanipulated UCB unit, and 8 patients received NiCord as a single UCB graft.

The researchers compared these patients to 101 patients who received standard single or double UCB transplants at Duke University from January 2005 to March 2015.

Patients in both groups received a total body irradiation-based myeloablative preparative regimen.

The median time to neutrophil engraftment was significantly shorter in the NiCord group than the control group—12.5 days and 27 days, respectively (P<0.001).

All 18 patients in the Nicord group and 100 patients in the control group had at least 1 infection.

Patients in the NiCord group had a significantly lower incidence of grade 2-3 bacterial infections than patients in the control group—22% and 54%, respectively (P=0.015).

However, there was no significant difference between the groups with regard to grade 2-3 viral infections (39% and 35%, respectively, P=0.729), fungal infections (0% and 5%, respectively, P=1.0), or non-microbiologically defined infections (0% and 17%, respectively, P=0.072).

In the first 100 days after transplant, patients in the NiCord group spent significantly more days out of the hospital than patients in the control group. The median number of days for each group was 74 and 53, respectively (P=0.002).

“These results demonstrate that the rapid hematopoietic recovery from NiCord transplantation results in clinical benefit, in comparison to similar site controls,” Dr Horwitz concluded.

Cord blood donation

Photo courtesy of NHS

VALENCIA, SPAIN—The expanded umbilical cord blood (UCB) product NiCord can provide clinical benefits in patients with high-risk hematologic malignancies, according to data presented at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation.

NiCord consists of cells from a single UCB unit cultured in nicotinamide—a vitamin B derivative—and cytokines that are typically used for expansion—thrombopoietin, interleukin 6, FLT3 ligand, and stem cell factor.

The data showed that patients transplanted with NiCord had fewer moderate to severe bacterial infections and shorter hospital stays than patients who received standard UCB transplants.

“We saw a significant reduction in serious bacterial infections during the first 100 days in the NiCord group,” said Mitchell Horwitz, MD, of the Duke University School of Medicine in Durham, North Carolina.

“This is encouraging because this type of infection is a major cause of early death following UCB transplantation. We also saw a significant reduction in hospitalization time in the NiCord group, indicating a faster recovery of these patients in comparison to those transplanted with standard umbilical cord blood.”

These results were presented at the meeting as abstract O090. The research was funded by Gamida Cell, the company developing NiCord.

Dr Horwitz and his colleagues analyzed 18 patients with high-risk hematologic malignancies—most with acute leukemia or myelodysplastic syndromes (90%)—who were transplanted with NiCord.

Ten of the patients received NiCord with a second, unmanipulated UCB unit, and 8 patients received NiCord as a single UCB graft.

The researchers compared these patients to 101 patients who received standard single or double UCB transplants at Duke University from January 2005 to March 2015.

Patients in both groups received a total body irradiation-based myeloablative preparative regimen.

The median time to neutrophil engraftment was significantly shorter in the NiCord group than the control group—12.5 days and 27 days, respectively (P<0.001).

All 18 patients in the Nicord group and 100 patients in the control group had at least 1 infection.

Patients in the NiCord group had a significantly lower incidence of grade 2-3 bacterial infections than patients in the control group—22% and 54%, respectively (P=0.015).

However, there was no significant difference between the groups with regard to grade 2-3 viral infections (39% and 35%, respectively, P=0.729), fungal infections (0% and 5%, respectively, P=1.0), or non-microbiologically defined infections (0% and 17%, respectively, P=0.072).

In the first 100 days after transplant, patients in the NiCord group spent significantly more days out of the hospital than patients in the control group. The median number of days for each group was 74 and 53, respectively (P=0.002).

“These results demonstrate that the rapid hematopoietic recovery from NiCord transplantation results in clinical benefit, in comparison to similar site controls,” Dr Horwitz concluded.

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