EMA/PE/0000238064 - paediatric investigation plan

allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded (MC0518)

Key facts

• Active substance:
  allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded (MC0518)
• Therapeutic area:
  Immune system disorders
• Decision number:
  EMA/PE/0000238064
• PIP number:
  EMA/PE/0000238064
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of acute graft-versus-host disease (aGvHD)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/04/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000238064 : EMA decision of 16 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for allogeneic bone marrow-derived pooled mesenchymal stromal cells ex-vivo expanded

Adopted Reference Number: EMADOC-1700519818-2038334