HemAcure - WP5
HemAcure - WP5
HemAcure - WP5

Work package 5: Cell PouchTM implantation, BOEC cell transplantation and preclinical studies

Leader: Dr. Philip Toleikis, undefinedSernova Corp.

 

Main objective

Sernova Corp’s main objective is to demonstrate preclinical safety and efficacy of a haemophilia A patient’s blood cells that have been corrected to express Factor VIII and transplanted within Sernova Corp’s manufactured undefinedCell Pouch™ device.  The objective will be completed in a haemophilia A animal model and the information will become part of the regulatory documentation for a human clinical study to treat haemophilia A patients.

 

Description of the tasks

Sernova Corp's Cell Pouch™
Sernova Corp's Cell Pouch™

To fulfil the objective, Sernova Corp will complete the following tasks:

 

  • Task 1: Manufacture, package and sterilization of Cell Pouches™ to Good Manufacturing Practice (GMP) specifications for the preclinical animal studies.

     

  • Task 2: Receive the human Blood Outgrowth Endothelial Cells (BOECs) Factor VIII expressing product, shipped from undefinedPartner 4 UNILO to Sernova, and test the cells to ensure they meet the criteria for preclinical evaluation.

     

  • Task 3: Complete human BOEC Factor VIII/Cell Pouch™ cell dosing and engraftment studies and use this information to design a safety/efficacy study of GMP human BOEC Factor VIII expressing cells in the Cell Pouch™.

     

  • Task 4: Conduct safety and efficacy evaluation of the GMP human BOEC Factor VIII expressing cells in the GMP manufactured Cell Pouch™ using an established haemophilia A animal model (provided by undefinedPartner 3 UPO).

 

Upon completion of the tasks, Sernova will use this information in preparation of regulatory documentation for a future human clinical study which includes an “Instruction for Use” document with knowledge transfer of the product to be used by physicians to treat Haemophilia A patients.

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