EMEA-000635-PIP01-09 - paediatric investigation plan

expanded human autologous mesenchymal adult stem cells extracted from adipose tissue (CX-401)

Key facts

• Active substance:
  expanded human autologous mesenchymal adult stem cells extracted from adipose tissue (CX-401)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/20/2010
• PIP number:
  EMEA-000635-PIP01-09
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  • Treatment of anal fistula of Crohn´s disease associated aetiology
  • Treatment of anal fistula of cryptoglandular aetiology (Non-Crohn)
  • Treatment of non-inflammatory anal fistula
• Route(s) of administration:
  Intralesional use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  19/02/2010
• Compliance check done:
  No

Decision

P/20/2010: EMA decision of 19 February 2010 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for expanded human autologous mesenchymal adult stem cells...

Reference Number: EMA/63059/2010