MHRA-100371-PIP01-21

Key Facts

Active Substance
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
Invented Name
HOLOGENE 5
PIP Number MHRA-100371-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Living tissue equivalent
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Treatment of Junctional Epidermolysis Bullosa (JEB)
Route(s) of administration
Route(s) of administration:
  • Cutaneous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) vector expressing the full-length LAMB3 cDNA.pdf
Published Date 30/06/2023