What Would be Your #1 Top FDA Reform on Stem Cells? Take our poll

The FDA is faced with years of a static budget and a rapidly growing stem cell and cell therapy for-profit sector.

It also faces criticisms (some that it has acknowledged are legit) from certain folks in the stem cell field.

If you could change just one thing about the FDA in terms of its oversight of the stem cell field, what would it be?

I realize some people may want to click more than one, but try to pick just your #1 in the poll above.

You can also click “none” if you feel the FDA is perfect or if you don’t like any of my answers you can click “other” (if so please explain in the comments).

11 thoughts on “What Would be Your #1 Top FDA Reform on Stem Cells? Take our poll


  1. Interesting poll Paul. I think Immunity should be the biggest factor with stem cells,. are the cell rejected?


  2. I voted “expand compassionate use” but I would prefer not restrict it to just “fatal” diseases but rather a slightly broader category of chronic diseases for which patients have exhausted their treatment options.


    • Thanks for the comment, Lee. I think the most challenging part is where to draw the line on eligibility.
      I am in favor of expanding compassionate use in the US myself, but I am concerned about an Italy-like situation where things could spiral out of control.


      • I agree with you Lee and that’s what I voted for. And Paul, here’s a question for you: If the stem cells being used on the 32 terminally ill patients were manufactured under cGMP and other appropriate guidelines, would you still characterized what’s going on there as “spinning out of control”?

        According to my reading of the poll, this is exactly the question that was asked and again, I would expand it in the way Lee suggested which of course would require clear guidelines.


  3. Thanks Paul, good poll. I voted for expanded compassionate use and like Lee I’d also go beyond just fatal diseases, to include those without treatment options. If it is proven safe and shows even moderate efficacy, give those people a chance. JMHO


  4. the FDA has to completely change the clinical trial process that was developed for drugs, when dealing with stem cell trials. Phases need to be shortened, safety less restrictive once results have come in, and compassionate use needs to be achieved faster. No side effects, positive results should mean faster to production.


  5. I voted for a more open culture. I find it surprising that firms in cellular therapeutics have to hold “pre-IND” meetings in order to figure out exactly what the FDA is looking for in terms of data. More guidance in early animal studies for these companies would dramatically improve the pre-clinical efficiency and bring treatments to clinic much faster IMO. Generally speaking, its much too early to pick up the pace once studying in humans. Although, once a particular source is deemed safe…it becomes a different argument.


  6. Evangelicals should not be appointed to direct any scientific endeavor.Anyone who still thinks the Earth is 6000 years old are in denial and are just obstructing scientific progress as the NIH director is doing at present
    The patented non embryo destruction HESC’s which have been sitting on his desk for over 2 years is a prime example of obstruction.They are better than what we have now to work with and they blow the obstructionists argument out of the water.The embryo does not have to die,it just needs some place to go to wait out the supposed second coming.Maybe the new Pope can set up a depository for these cells as they wait for the end of times.
    Religious conseratives have been on the wrong side of almost every scientific advancement throughout history.This time is no different.


  7. Paul, A choice here is a lot like ice cream, tough to choice just one flavor.
    I think like most people, especially after hearing about the plight of certain patients, I would pick “expanded compassionate use”. But that said, crafty people looking to make a buck can be very creative, and a person in a desperate situation could be lead into believing false hopes.
    Your Blog provides another layer of education for anyone using the internet with a desire to educate themselves.
    I maybe like many here field calls daily about a person looking for any ray of hope to their affliction. I then also see at conventions and meetings the “chicken hawks” developing the pitch on how to commercialize on it and prey on patients.
    Although Erectile Dysfunction does not fall into this category, it was brought to my attention that now ED can be treated with a Stem Cell Treatment….ouch if its an IM injection! This coupled with the Vampire Facelife is going to confuse the patient and consumer….
    Off to see the POPE! Ciao!


  8. I agree with 1, 2, 4,5 and with Lee in most aspects but wonder if some form of medical and financial protections could be set up for vulnerable patients particularly if they choose to be payors.

    I am completely aware that we are seeing a media driven picture and we have no realistic knowledge of what the FDA has to deal with. I would like to hear from them and then see what CAN be done with the available resources.

    Blaming and dichotomies solve nothing and hurt people. The science v medicine and people against regulation just disrupt innovation in painful ways and slow the progress of getting evidence into practice. Instead of talking up the limitations why not find and grow the process’s that can build collaboration and a future. There are unprincipled components in every area of life. lets not let their darkness block the light and the power of science medicine and informed shared decision making

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