Drugs and Medicinal Substances

Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel

Antineoplastic and Immunomodulating Agents

Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel is a cancer treatment for use in hematopoietic stem cell transplantation, authorized for medical use in the European Union in August 2025. It has two cellular components, both derived from umbilical cord blood. The first, dorocubicel, consists of CD34+ hematopoietic stem cells expanded outside the body in cell culture with the small molecule UM171, which is meant to enhance their self-renewal while keeping them undifferentiated and so speed engraftment and immune reconstitution. The second component is non-expanded CD34- cells, a mixed population of cord blood cells that are not manipulated in culture and are believed to support the graft through paracrine signaling. Nothing here is medical advice.

Facts
Approved Use
Treatment of adults with haematological malignancies (blood cell cancers) who need an allogeneic stem cell transplant after myeloablative conditioning and have no other suitable donor cells 2
First Approved / Isolated Year
2025 1
Significant Risk
Acute graft-versus-host disease was reported in 60% of patients up to 100 days after transplant and chronic graft-versus-host disease in 13% up to one year; common side effects include low blood cell levels, high blood pressure, infections and engraftment syndrome 2
Classification
Approval Status
Approved 1
ATC Class
L: Antineoplastic and Immunomodulating Agents 1
Connections

Long-Form Articles

Sources
1. Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel (Wikipedia)
  • Lead paragraph
    cancer treatment for use in hematopoietic stem cell transplantation
  • Lead paragraph [approval-status]
    It was authorized for medical use in the European Union in August 2025.
View the Source
2. New stem cell therapy to treat patients with blood cancers (EMA, 2025)
  • Body, indication
    to treat adults with haematological malignancies (blood cell cancers)
  • Body, side effects and risks
    Acute graft-versus-host disease (GvHD), when donor/transplanted cells attack the body
View the Source
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