The group formed in opposition to the FDA’s attempts to create out of thin air a new drug class, the patent’s own stem cells.

 

As an example, IPS cells where new genes are inserted carry the most significant risk to patients.  As a result, ASTCA does not allow this type of genetic manipulation to occur.  Again, IPS may well produce great stem cells with much more capabilities, but this cell treatment is nowhere near ready for prime time, nor even clinical trials in my opinion.  In addition, ASCTA limits what can be done to the cells once they are removed from the body.  For example, ASCTA only allows stem cell processing that mimics how the body would normally treat adult stem cells. 3.  ASCTA creates a new definition for how cells are processed and how each of the “cell lines” can be used.  Slowly at first, check for complications, then more patients, check for complications, then more patients, etc…  In addition, ASCTA is creating a national treatment registry for adult stem cell treatments. This will allow all medical practices to share safety and efficacy data so that one doctors experience with a stem cell line can be used by another.  All of this means the world’s first sensible guidelines for balancing safety with access.  Rather than being mired down in decades of bureaucratic red tape that will limit access without adding to safety, the ASCTA process will slice through red tape while still enforcing strict safety protocols. 4.  Compassionate use.  If a patient has a terminal disease and is waiting around to die because no treatments are available, why does anybody care about taking additional risks by the patent’s own adult stem cells as therapy?  Meaning these patients should have the ability to accept the higher risk of a promising stem cell line without a proven track record.  The ASCTA guidelines allow for this type of controlled compassionate use. These are just a few areas where the ASCTA guidelines exceed and surpass existing guidelines and regulatory theories.  The importance of all of this?  Safe stem cell therapies will now be between you and your doctor, not laden with bureaucracy and the big problems that big pharma brings.

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