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New Stem Cell Therapy Approved for Cancer Patients Without Bone Marrow Match - Cord Blood

Cord Blood

and Stem Cell Banking

New Stem Cell Therapy Approved for Cancer Patients Without Bone Marrow Match

Scientist testing stem cells

The FDA has recently approved a new cell therapy called Omisirge for cancer patients who are unable to find a suitable bone marrow donor. Omisirge is derived from modified donor umbilical cord blood and is the first “expanded” umbilical cord blood product to receive FDA approval.

Omisirge offers an alternative option to patients in need of a stem cell transplant, especially those suffering from blood cancers. The therapy has been shown to significantly reduce the time it takes for engraftment, which is the process of the transplanted stem cells establishing themselves in the patient’s body.

In a Phase 3 clinical trial conducted by Gamida Cell, the manufacturer of Omisirge, researchers compared the transplantation of Omisirge to standard umbilical cord blood transplantation. The trial included 125 patients with various blood cancers. The results showed that patients treated with Omisirge had a significantly faster time to engraftment compared to those treated with standard umbilical cord blood transplant.

Further analysis also revealed that Omisirge reduced the time to platelet engraftment by 13 days and had lower rates of infection and hospitalization. While the trial did not investigate long-term outcomes extensively, there were no significant differences in factors such as graft-versus-host disease, relapse rate, and overall survival between the two treatment groups.

One of the advantages of Omisirge is its ability to combine the benefits of both bone marrow and umbilical cord blood as a graft source. It engrafts quickly like bone marrow, reducing the risk of infection, but also offers potential long-term advantages, such as better survival rates and lower risk of graft-versus-host disease.

The approval of Omisirge provides oncology experts with more treatment options for patients who cannot find a fully matched bone marrow donor. It may also require a re-evaluation of the clinical algorithms used to select a graft source.

It’s important to note that Omisirge carries similar risks to other umbilical cord products, including infusion reactions, graft-versus-host disease, engraftment syndrome, and graft failure. Patients receiving Omisirge may need to be monitored for signs of serious infections and for potential long-term complications.

This FDA approval represents a significant advance in cell therapy treatment for patients with blood cancers and demonstrates the FDA’s commitment to supporting innovative therapies for life-threatening illnesses.