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WP n.º

7

Title

Good practices for demonstrating safety and quality through recipient follow-up: Hematopoietic Stem Cells 

Short description 

The WP7 focuses on the development of methods to establish the safety and efficacy of HSC, within the general outline of validation of novel tissue and cell applications. Existing practices will be taken into account, like the guidelines given by JACIE and Netcord-FACT and also the work of the EBMT will be included in the outcomes.

Specific objectives

 

  • To identify the different HSC and the way they are collected, processed, and applied into patients. Also an inventory will be made of methods that are currently in use to evaluate the clinical applications, like clinical trials and patients follow programs.
  • To determine HSC specific criteria and/or parameters for clinical application or research with novel HSC therapies in patients. 

 

Expected outcomes

 

  • A database of well-established HSC products, their clinical indications and their processing methods
  • An overview of existing practices for the evaluation of safety and efficacy of currently known HSC products
  • A guideline in which the minimal requirements for process validation and patient follow-up  are described in order to ensure the safety and establish minimal efficacy of novel cell therapies for patients

 

How the work will be carried out

 

  • Formation of the WP: identification of the member and other experts in the field
  •  (Literature) search of existing HSC products, indications and the methods used for validation and demonstration of safety and clinical efficacy
  • Web oriented working method to assess the outcome of the search
  • First technical meeting (in association with scientific conferences) to discuss the overview.
  • Delivery of a database with existing HSC products, information on processes and indications for use, and methods to effectively establish clinical outcome
  • Second technical meeting to identify minimal requirements for the  assessment of the safety and clinical efficacy of novel HSC
  • Web oriented writing of the concept Guidelines for HSC novelties
  • Third technical meeting to discuss the draft guideline
  • Web oriented correction round for the draft Guidelines
  • Final correction and delivery of the guideline for novel HSC.

 

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