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Zemcelpro: EMA Recommends approval for Novel Hematopoietic Stem Cell Transplant Therapy
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In a significant step forward for patients with hematological malignancies, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting conditional marketing authorization for Zemcelpro. This innovative medicinal product is intended for adult patients with blood cancers who require an allogeneic hematopoietic stem cell transplantation (HSCT) but lack a suitable matched donor [[1]].
What is Zemcelpro?
Zemcelpro is an experimental product composed of allogeneic umbilical cord-derived CD34− cells, non-expanded/dorocubicel, designed for use in hematopoietic stem cell transplantation. It consists of two distinct cellular components derived from umbilical cord blood:
- Dorocubicel: CD34+ hematopoietic stem cells expanded ex vivo using the small molecule UM171. UM171 enhances the self-renewal capacity and proliferative potential of hematopoietic stem cells while preserving their undifferentiated state [[1]].The expansion of CD34+ cells aims to accelerate engraftment and improve immune system reconstitution following transplantation.
- Non-expanded CD34− cells: A heterogeneous population of umbilical cord blood-derived cells that may include supportive stromal or immune-modulating cell types. These cells are not manipulated in culture prior to administration and are believed to contribute to the overall graft function and engraftment process through paracrine signaling [[1]].
Did You Know? Hematopoietic stem cell transplantation (HSCT) is a procedure to replace damaged or diseased bone marrow with healthy stem cells [[2]].
The Role of Hematopoietic Stem Cell Transplantation
Hematopoietic stem cell transplantation (HSCT) is a medical procedure used to replace damaged or diseased bone marrow with healthy hematopoietic stem cells [[3]]. These stem cells, found in the bone marrow and blood, are capable of developing into all types of blood cells: white blood cells, red blood cells, and platelets [[2]]. HSCT is frequently enough used in the treatment of cancers like leukemia and lymphoma, as well as other blood disorders.
The goal of HSCT is to restore the bone marrow’s ability to produce healthy blood cells. This can be achieved through different types of transplants
