MHRA-100370-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • EX VIVO EXPANDED AUTOLOGOUS HUMAN CORNEAL EPITHELIAL CELLS CONTAINING STEM CELLS
Invented Name
  • Holoclar
  • Holoclar
  • Holoclar
PIP Number MHRA-100370-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Living tissue equivalent
Therapeutic area
Therapeutic area:
  • Ophthamology
Conditions / Indications
Conditions / Indications:
  • Treatment of limbal stem cell deficiency due to ocular burns
Route(s) of administration
Route(s) of administration:
  • Ophthalmic use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
04/09/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100370-PIP01-21-M01 -C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):EX VIVO EXPANDED AUTOLOGOUS HUMAN CORNEAL EPITHELIAL CELLS CONTAINING STEM CELLS.pdf
Published Date 01/05/2026