A rapid-acting bone marrow transplant developed by the Israeli biotech Gamida Cell was engrafted in blood cancer patients 10 days faster than standard umbilical cord blood transplants in a phase III trial.
The trial recruited 125 blood cancer patients in more than 50 clinical centers globally. One group received a standard transplant of donor umbilical cord blood cells and another group received Gamida’s treatment omidubicel, which consists of umbilical cord blood cells that are expanded and cultured in the lab.
According to the trial results, omidubicel established itself in the patients and started making healthy new immune cells after around 12 days, measured by counting cells called neutrophils in the blood. This was significantly faster than the 22 days it took in patients given a regular umbilical cord blood transplant.
Blood cancer patients often receive stem cell transplants to replace bone marrow cells that are damaged by chemotherapy or radiation therapy. Donor stem cell transplants can come from adult bone marrow cells, stem cells in the blood, or umbilical cord blood stem cells.
A common problem with bone marrow transplants is compatibility, where the donor’s cells could fail to engraft or even attack the recipient if the cell types don’t match properly. This problem is less common in umbilical cord blood transplants than other sources, but this type of transplant also provides a lower dose of stem cells, which can delay the engraftment process.
To solve this issue, Gamida Cell’s treatment is designed to take donor umbilical cord cells and boost their stem cell count in the lab prior to administering the treatment to patients.
“These results have the potential to substantially move the field forward and represent an important step toward making stem cell transplantation more accessible and more successful for patients with lethal blood cancers,” stated Mitchell Horwitz, Principal Investigator and Professor of Medicine at the Duke Cancer Institute, USA.
“Shortening the time to engraftment is clinically meaningful, as it can reduce a patient’s time in the hospital and decrease the likelihood of infection.”
The company aims to apply for FDA approval in late 2020, with a potential commercial launch in 2021. According to a conference call today, Gamida Cell had completed its phase III enrollment in December. This meant that the trial was luckily unaffected by the onset of the Covid-19 pandemic, which has delayed clinical trials for many companies worldwide.
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