"The Wednesday regulatory decision covers the treatment of adults with hematological malignancies, including leukemias and myelodysplastic syndromes, that require an allogeneic hematopoietic stem cell transplant. To be eligible for this therapy, suitable donor cells must not be available to patients. The new product of Montreal-based ExCellThera, known in development as UM171 cell therapy, will be commercialized under the brand name Zemcelpro."
"In other cases, a patient may already have antibodies that would reject donor cells. Cord blood has cells that are less likely to be rejected, but this source also has few cells. ExCellThera's technology works with a small volume of stem cells, multiplying them in cell culture to provide the allogeneic stem cells required for blood cancer patients who lack a suitable donor."
Many patients requiring allogeneic hematopoietic stem cell transplants cannot access matched donor cells because of donor unavailability, age, health, or patient antibodies. Cord blood cells are less likely to be rejected but are limited in number. ExCellThera multiplies small volumes of cord‑blood stem cells in culture to produce sufficient allogeneic stem cells. The UM171 cell therapy, commercialized as Zemcelpro, received European Commission approval for adults with hematological malignancies needing allogeneic transplant when suitable donor cells are unavailable. A Phase 2 trial across the U.S., Canada and Europe reported overall survival of 67% and progression‑free survival of 63%.
Read at MedCity News
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