EMEA-002737-PIP01-19 - paediatric investigation plan

Autologous CD3+CD4+CD25+CD127-FoxP3+ polyclonal regulatory T cells ex vivo expanded

Key facts

• Active Substance:
  Autologous CD3+CD4+CD25+CD127-FoxP3+ polyclonal regulatory T cells ex vivo expanded
• Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-Metabolism
  • Other
• Decision number:
  P/0251/2022
• PIP number:
  EMEA-002737-PIP01-19
• Pharmaceutical form(s):
  Suspension for infusion
• Condition(s) / indication(s):
  Treatment of type 1 diabetes mellitus
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  PolTreg SA

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/07/2022

Decision

P/251/2022 : EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for autologous CD3+CD4+CD25+CD127-FoxP3+ polyclonal regulatory T cells ex vivo expanded (EMEA-002737- PIP01-19)

AdoptedReference Number: EMA/579390/2022