Sernova Recap + Excerpts (Timing) | SVA.V Message Board Posts

Sernova Corp.

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Msg  151 of 176  at  6/18/2019 11:02:53 AM  by

jwallisca


Sernova Recap + Excerpts (Timing)

From second link below (FDA) what Sernova is looking for and timing:

Primary Outcome Measures :
  1. To assess the safety of the Cell Pouch™ following implantation, and islet transplantation, by evaluating the incidence and severity of adverse events (AEs) determined to be probable or highly probable to the Cell Pouch™ [ Time Frame: 365 days ±14 days ]
    Safety will be assessed by evaluating the incidence and severity of adverse events (AEs) determined to be probable or highly probable to the Cell Pouch™ following initial Cell Pouch™ implantation, at the time of islet transplantation, and following islet transplantation, and throughout the study up to 365 days ±14 days post-islet transplantation

Secondary Outcome Measures :
  1. Survival of endocrine tissue in the Cell Pouch™ (defined by positive staining of islets during histological analysis) [ Time Frame: 90±5 days post-transplant for sentinel Cell Pouch™ ]
    Survival of endocrine tissue in the Cell Pouch™ (defined by positive staining of islets during histological analysis), as evaluated at day 90±5 days (post-removal of sentinel Mini Cell Pouch™); or post-removal of Cell Pouches™ at any time during the study
  2. Proportion of participants with a reduction in severe hypoglycemic events [ Time Frame: From Day 0 to 90±5 ; Day 90±5 to Day 180±5; Day 180±5 to Day 365±14 following final Cell Pouch™ transplant and/or last transplant ]
    Number of participants with a reduction in severe hypoglycemic events following final Cell Pouch™ transplant and/or last islet transplant
  3. Proportion of participants with a reduction in HbA1c >1mg% [ Time Frame: From Day 0 to 90±5 ; Day 90±5 to Day 180±5; Day 180±5 to Day 365±14 following final Cell Pouch™ transplant and/or last transplant ]
    Number of participants with a reduction in HbA1c >1mg% following final Cell Pouch™ transplant and/or last islet transplant

https://web.tmxmoney.com/article.php?newsid=7178985172350577&qm_symbol=SVA

https://www.clinicaltrials.gov/ct2/show/NCT03513939


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