Amarantus Bioscience Holdings Inc (AMBS)

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Lonza has to complete their work before the trial opens.

"Ongoing engineering run activities are progressing successfully, and Amarantus expects to complete the necessary steps to confirm the process in January. Upon completing the validation studies, Amarantus will be ready from the operational perspective to open the planned Phase 2 clinical study for the treatment of full thickness thermal burns covering over 50% of the body. The trial is being conducted under a Collaborative Research & Development Agreement (CRADA) with the U.S. Army at the Institute for Surgical Research at Fort Sam Houston in Texas."

Milestones towards validation are as follows:

1. Aseptic process simulation execution and qualification of the process and personnel used in manufacturing:
Completed in November 2015

2. Initial engineering run whereby autologous full thickness skin from an adult human donor is produced:
Completed in December 2015

3. Confirmatory engineering run whereby autologous full thickness skin from an adult human donor is produced:
In progress - Expected completion in January 2016

http://www.amarantus.com/news/press-releases/detail/2037/amarantus-provides-update-on-cgmp-manufacturing-validation