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Manufactured red blood cells (mRBCs) are erythroid cells produced ex vivo from various stem cell sources, including CD34+ hematopoietic stem cells (HSCs) derived from bone marrow, peripheral blood, or umbilical cord blood, as well as induced pluripotent stem cells (iPSCs) and immortalized erythroid cell lines. This technology is being developed as a sustainable alternative to traditional donor-derived blood transfusions, aiming to address global blood shortages and reduce transfusion-related adverse reactions. mRBCs are particularly valuable for patients with rare blood group types or those with inherited anemias and hemoglobinopathies (such as sickle cell disease and β-thalassemia) who require frequent transfusions and are at high risk of alloimmunization. The manufacturing process involves the expansion and differentiation of progenitor cells into mature, enucleated reticulocytes and erythrocytes using specialized bioreactors and growth factor cocktails. In 2022, the RESTORE trial in the United Kingdom, led by NHS Blood and Transplant and the University of Bristol, became the first clinical study to evaluate the recovery and survival of laboratory-grown red cells in human volunteers.
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