Monday, January 22, 2018

Stem Cell treatment for PD

A word about stem cell clinical trials.  Here’s a research update on stem cells, one of many promising avenues in PD research: https://www.michaeljfox.org/foundation/news-detail.php?stem-cells-safe-in-pre-clinical-parkinson-disease-study I’ll quote from the update, dated August, 2017: Currently, there are no approved or accepted stem cell treatments for Parkinson's disease, and so, The Michael J. Fox Foundation urges people with PD to view so-called clinics offering stem cell therapies for PD with 'buyer beware' skepticism. 

There are new stem cell study results related to PD coming out all the time, but almost all are in petri dishes or in animals.

That means if somebody is promising treatment using stem cells, you should look at their claims long and hard.   If they say it is a clinical trial, but then want you to pay big bucks, then you need to ask a whole lot of questions, and probably want to grab your wallet and run.  Genuine clinical trials don’t cost you anything.

I looked up stem cell research trials on ClinicalTrial.gov.   Legitimate stem cell research is still carefully trying to see if the therapy is effective – and safe.  For example, studies at major medical centers use only 4 or 12 patients to check for safety of stem cell therapy – they want to risk as few people as possible.  So why would a non-university center take any warm body older than 16 (yes – age 16), for doing a “study” of 3,000 patients.  The non-university (read for-profit) center has a very interesting page on their website:  ... [We]  are not offering stem cell therapy as a cure for any condition, disease, or injury.  No statements or implied treatments on this website have been evaluated or approved by the FDA.  They want your money, but what they are offering is not a cure.  Hmmm.

Further, the for-profit clinic is offering patient funded research.  In a real clinical trial, treatment costs nothing for the people who participate.  Like I said: You probably want to run.  Legit studies are still finding out of the treatment is safe.

Remember that inclusion in the government clinical trial database does not mean it’s been okayed by the government.  In fact, Clinical Trials.gov states: Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators.

This just in: the FDA has issued a Warning Letter to American CryoStem, the manufacturer of stem cells used by for-profit clinics to "treat" PD and other conditions. The FDA said these stem cells are a drug being marketed without benefit of FDA approval.  Further - and this is really scary - the FDA found "evidence of significant deviations from current good manufacturing practice requirements... such as potentially being contaminated with microorganisms or having other serious product quality defects. Specific deviations included unvalidated processes, an inadequately controlled environment, lack of control of components used in production, and a lack of sufficient and validated product testing." So the company isn't checking thoroughly to make sure the cells aren't contaminated, among many other basic controls. These are cells that the clinics want to put in your brain.  For further information, see:  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm591371.htm 

Stem cells might be wonderful, and some very gifted researchers are working hard to find out how stem cells work, how stem cells can be used to treat PD, and if they are safe.  But our wanting this to be the answer doesn't make it the answer. 

God knows that we want a magic pill but the closest thing we have so far is exercise.

Image from Pixabay.

No comments:

Post a Comment

Great tools to use during the Pandemic

Some organizations have stepped up for pwp who have lost socialization, and usually exercise programs and support groups.  Even for those ex...