Posted On: 08/03/2016 10:03:36 AM
Post# of 30082
From the Edison report:
Phase II ESS-W Clinical trial planned for H215
Amarantus expects recruitment to start in H215 for a two- to three-site Phase I/IIa trial with an improved and better standardised version of ESS-W in 10 patients with deep partial and fullthickness burn wounds (data expected in 2016). Efficacy will be compared to that of meshed spitthickness autograft (AG). Studies are expected to receive partial funding by a US government grant from the Armed Forces Institute for Regenerative Medicine (AFIRM); $1m has already been secured and additional funds may be available. Amarantus anticipates that total study costs will not exceed $2.5-3.0m. Subsequently, a Phase III registration study would be needed for approval (which may require less than 100 patients).
Phase II ESS-W Clinical trial planned for H215
Amarantus expects recruitment to start in H215 for a two- to three-site Phase I/IIa trial with an improved and better standardised version of ESS-W in 10 patients with deep partial and fullthickness burn wounds (data expected in 2016). Efficacy will be compared to that of meshed spitthickness autograft (AG). Studies are expected to receive partial funding by a US government grant from the Armed Forces Institute for Regenerative Medicine (AFIRM); $1m has already been secured and additional funds may be available. Amarantus anticipates that total study costs will not exceed $2.5-3.0m. Subsequently, a Phase III registration study would be needed for approval (which may require less than 100 patients).
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