The American Stem Cell Therapy Association (ASCTA) released it’s stem cell treatment guidelines yesterday. These are the blue print for how stem cell therapy will be practiced by physicians all over the country. 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. These guidelines are much more advanced and specific than any other produced to date. The ISSCR released guidelines last year for clinical translation (moving cells from the lab into treatments). The Regenexx procedure team applauded these ISSCR guidelines as general guideposts for moving from research to the bedside. However, these guidelines were not specific enough to provide a road map for how that translation would actually occur, instead they were more a healthy thought provoking exercise for all the stakeholders involved in stem cell work. The American Stem Cell Therapy Association has now provided that road map for everyday safe stem cell use. Some high points of the guidelines:
1. Many patients who could be helped by stem cell therapies will not have access to them in time to prevent more disability or their demise. To allow these patients to access safe stem cell therapy more quickly, the ASCTA reduces the types of stem cells being used to the safest candidate, the patent’s own adult stem cells. There are many stem cell types, all with great potential but many with great potential risks. There is a video on this topic.
2. Many stem cell preparations being proposed are potentially hazardous. 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.