Overview of Omicel
What is Omicel?
Omicel (omidubicel-onlv) is an advanced cell therapy designed to assist the body in recovering its immune system and blood cell production following specific medical treatments. It is categorized as a modified allogeneic hematopoietic stem cell therapy.
Composition and Development
Omicel is created using stem cells derived from umbilical cord blood. These cells undergo a specialized laboratory process known as nicotinamide (NAM) technology. This process is designed to expand the number of hematopoietic stem and progenitor cells while maintaining their functional capabilities.
Unlike traditional cord blood transplants, which contain a limited number of stem cells, this technology produces a more concentrated graft of cells intended to accelerate the recovery of the recipient's blood-forming system.
Mechanism of Action
The primary function of Omicel is to provide a source of healthy stem cells that can migrate to the bone marrow. Once there, these cells begin the process of hematopoiesis, which is the production of new white blood cells, red blood cells, and platelets.
By increasing the quantity of progenitor cells, the therapy aims to shorten the period of time a patient remains without adequate levels of neutrophils, a type of white blood cell essential for fighting infections. This process is known as neutrophil engraftment.
Clinical Application
Omicel is used in the context of hematopoietic stem cell transplantation for individuals with certain blood cancers, such as leukemia, lymphoma, or myelodysplastic syndromes. It is typically utilized when a patient requires a transplant but a matched related or unrelated adult donor is not available.
Before receiving the therapy, patients undergo a conditioning regimen, which involves high-dose chemotherapy or radiation to clear the bone marrow of diseased cells and prepare the body for the new stem cells.
Regulatory References

