EMEA-003137-PIP01-21 - paediatric investigation plan

Ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) vector expressing the full-length LAMB3 cDNA (Hologene 5)

Key facts

• Active substance:
  Ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) vector expressing the full-length LAMB3 cDNA (Hologene 5)
• Therapeutic area:
  Dermatology
• Decision number:
  P/0375/2022
• PIP number:
  EMEA-003137-PIP01-21
• Pharmaceutical form(s):
  Living tissue equivalent
• Condition(s) / indication(s):
  Treatment of epidermolysis bullosa
• Route(s) of administration:
  Implant use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/09/2022
• Compliance check done:
  No

Decision

P/0375/2022: EMA decision of 9 September 2022 on the agreement of a paediatric investigation plan for ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) (EMEA-003137-PIP01-21)

Adopted Reference Number: EMA/706927/2022