The FDA and stem cells

One question people often ask me is “Why is this taking so long?”  and by “this” they mean getting stem cells to the patients who need them.

The answer to that question is complex, but one frequent complaint I hear is that the problem is the FDA being too strict. Almost exactly a year ago I did a post on the fact that neither ACT nor Geron had received FDA clearance for their early trials. Of course that has changed.

As a scientist who studies and worries a great deal about the tumorigenicity of stem cells, I personally think the FDA is doing its job of being extremely careful about the safety of stem cell-based drugs and the need for compelling pre-clinical safety data.

However, could the FDA be moving things along faster but preserving safety at the same time?

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1 thought on “The FDA and stem cells”

  1. Genome Institute of Singapore Scientists Discover How to Control Fate of Stem Cells Without the Risk of Developing Cancer Cells

    Dr Kian Leong Lee and his team of scientists studied how a single signaling system known as the Nodal/Activin pathway tells stem cells what cell type they should eventually become. The pathway is able to specify a wide range of eventual cell types, challenging the current belief that chemical signaling systems are highly specific and only control a limited number of outcomes. This discovery is a major step forward for stem cell therapies and personalised medicine; by exploiting this signaling system, scientists will be able to control the eventual fate of a stem cell by simply adjusting the chemical environment of a cell.

    This method of controlling stem cell differentiation also avoids modifying the genetic material of the cell, a procedure that might lead to the cells becoming cancerous.

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