Landmark FDA Approval of Expanded Cord Blood Product

In a significant development, the U.S. Food and Drug Administration (FDA) has granted approval to an expanded cord blood product for use in stem cell transplantation. This approval, received on April 17, 2023, has the potential to transform the field of regenerative medicine and bring hope to adults and pediatric patients aged 12 and above battling high-risk blood cancers and other hematological disorders.

First-ever approval of an “Expanded” Cord Blood Product

For over three decades, cord blood has been a valuable resource in regenerative medicine, particularly in hematopoietic stem cell transplant (HSCT).

However, a persistent clinical challenge has been the limited volume of cord blood collected, particularly when it comes to adult patients requiring stem cell transplants based on their body weight.

The newly FDA-approved expanded cord blood product called Omisirge™ developed by Gamida Cell Ltd., addresses this cell volume challenge by significantly increasing the number of donor cord blood stem cells available for transplantation.

A Turning Point for Cord Blood

The FDA's recognition of Omisirge marks a significant milestone in regenerative medicine. This approval paves the way for providing new clinical solutions for patients where an efficacious dose of hematopoietic stem cells is deemed to be the most appropriate course of treatment.

Omisirge, administered intravenously, is derived from a carefully selected cord blood unit. It undergoes a culturing process in the presence of nicotinamide (a form of vitamin B3), which helps expand the progenitor cells found in cord blood. These cells play a crucial role in restoring the patient's bone marrow and blood cell counts post-transplant.

Enhancing Recovery Rates

Omisirge’s core promise lies in its ability to significantly expedite the recovery of important immune cells like neutrophils, which are essential for defending against infections.

A clinical trial led by Dr. Mitchell Horwitz at Duke Cancer Institute, showcased impressive results with Omisirge. Patients who received this therapy experienced faster engraftment of neutrophils reducing the risk of severe infections.

Stem cell transplantation offers new hope to patients

Additionally, the trial uncovered secondary benefits such as reduced hospitalization during the critical 100-day period post-transplant, leading to an improved overall quality of life. Omisirge has the potential to address healthcare disparities by widening access to stem cell transplantation.

In the evolving medical field where finding a fully compatible donor remains a challenge for many patients, Omisirge brings hope as a promising addition to available treatment options.

Shaping the Future of Healthcare

In conclusion, the approval of Omisirge stands as a noteworthy event in the realm of regenerative medicine. ViaCord remains committed to advancing the field and improving patient lives. As we look to the future, we envision a healthcare landscape where innovative solutions like Omisirge become the norm, expanding the horizons of what is possible.

Stay Informed and Explore Further

For more information on cord blood banking and the latest breakthroughs in regenerative medicine, visit ViaCord.

To dive deeper into the science behind the product, read about the FDA's approval in detail here.

Disclaimer: Banking cord blood does not guarantee that treatment will work, and only a doctor can determine when it can be used. Revvity or ViaCord does not endorse or make recommendations with respect to research, medication, or treatments. All information presented is for informational purposes only and is not intended as medical advice.

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