Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel
| Combination of | |
|---|---|
| Allogeneic umbilical cord-derived CD34- cells, non-expanded | Stem cells |
| Dorocubicel | Stem cells |
| Clinical data | |
| Other names | UM171 Cell Therapy |
| Routes of administration | Intravenous |
| ATC code | |
Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel is an experimental cancer treatment under investigation for use in hematopoietic stem cell transplantation.[1] It is composed of two distinct cellular components both derived from umbilical cord blood.[1]
The first component is dorocubicel,[2] which consists of CD34+ hematopoietic stem cells that have been expanded ex vivo in cell culture using the small molecule UM171.[3] UM171 is a pyrimido-indole derivative shown to enhance the self-renewal capacity and proliferative potential of hematopoietic stem cells while preserving their undifferentiated state, or stemness.[1] Expansion of CD34+ cells aims to accelerate engraftment and improve immune system reconstitution following transplantation.
The second component consists of non-expanded CD34− cells,[1] which are 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]
Society and culture
Legal status
In June 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Zemcelpro, intended for the treatment of adults with hematological malignancies requiring an allogeneic hematopoietic stem cell transplantation for whom no other type of suitable donor cells is available.[1][3][4]
References
- ^ a b c d e f "Zemcelpro EPAR". European Medicines Agency (EMA). 20 June 2025. Retrieved 28 June 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ World Health Organization (2024). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 91". WHO Drug Information. 38 (1). hdl:10665/378096.
- ^ a b "Zemcelpro (UM171 Cell Therapy) receives positive CHMP opinion for treatment of blood cancer patients without access to suitable donor cells" (Press release). ExCellThera. 19 June 2025. Retrieved 28 June 2025 – via PR Newswire.
- ^ "New stem cell therapy to treat patients with blood cancers". European Medicines Agency (EMA) (Press release). 20 June 2025. Retrieved 30 June 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.