How to Volunteer for Clinical Stem Cell Research

Now that Pres. Obama has revoked the Bush administration's restrictions on federal funding of embryonic stem cell research, patients everywhere are wondering how they can participate in a stem cell research study at the clinical level. Unfortunately, except in one special exception (see the Tips section below) it's still too early to talk about clinical research using embryonic stem cells. Scientists are still experimenting with animals to make sure treatments are both safe and effective. As to the Obama action, the National Institutes of Health has to write guidelines for conducting ethical research using federal tax dollars. (That will take until the middle of summer.) Once those guidelines are in place, NIH will begin evaluating research proposals and awarding grant funding. So, the promise of embryonic stem cell research is still far from being fulfilled in a clinical setting.

But there is already a lot of clinical (i.e., human focused) research being done using adult (non-embryonic) stem cells. These clinical trials are being conducted in a variety of diseases and disorders. Here are some tips on how to find and volunteer for clinical stem cell research. (NOTE: Stem cell research involving blood diseases such as leukemia has been ongoing for decades.)

Difficulty: Moderate

Instructions

Things You'll Need:

• Internet access
• Time to read
• Determination

1. 
    
   Start by learning about stem cells

   Learn all you can about stem cells and stem cell biology. There's an awful lot of misinformation floating around. It's important that you understand the basics: the difference between embryonic stem cells, adult stem cells, and induced pluripotent (iPS) cells. The NIH is a great place to start. See the Resources section below for a link to NIH Web pages that give you all the information you need.

2. 
    
   Learn the FDA clinical study process

   Learn all you can about clinical studies approved by the U.S. Food and Drug Administration (FDA). Stay away from treatments and therapies (usually offered outside the United States) that have not undergone the FDA-monitored pre-clinical and clinical experimentation process. These unapproved stem cell treatments are probably scams: unproven scientifically, hugely expensive, mostly ineffective and possibly dangerous. See the Resources section below for a link to FDA Web pages that provide a thorough background briefing on the clinical research process.

3. 
    
   Be aware of stem cell scams

   Speaking of scams, before you are tempted to apply for stem cell treatments offered in clinics outside the United States, educate yourself on the dangers of expensive, unproven stem cell therapies. The Resources section includes a link to the Web site of the International Society for Stem Cell Research. The organization offers a free 8-page handbook downloadable in PDF for patients tempted to go overseas for stem cell treatments. It includes a long list of questions to ask the treatment provider before you spend a nickel.

4. 
    
   Search the FDA database

   Once you've educated yourself about stem cells, clinical trials, and stem cell scams, you can easily locate clinical trials approved by the FDA that are recruiting patient volunteers. The FDA database is simple to search using key words (e.g., "stem cell AND heart attack"). I did a search recently on "Parkinson's AND stem cell" and found one clinical trial sponsored by two NIH institutes. The study was launched in 2002 and is still recruiting patients. The Resources section has the link to the search engine at ClinicalTrials.gov.

5. Once you've found a clinical study that you're interested in, read the eligibility requirements. These will tell who will be accepted and who will be rejected and why. If you meet the basic requirements, find the contact information. Then call or send an e-mail to ask for more information.

6. 
    
   Talk to your doctor

   Lastly, consult your physician before applying for a clinical study. He or she may know something about your physical condition that would prevent you from participating in a study. It is important for clinical researchers to know everything about your physical history before accepting you.

Tips & Warnings

• You don't need a Ph.D. in biology to volunteer for a stem cell-based clinical study. But you really do need to bone up on the basics. Follow every step above and you'll be armed with enough information to ask the right questions and be accepted in the right study.
• Keep in mind that nobody in the United States is conducting clinical studies using controversial human embryonic stem cells (the ones Pres. Obama just addressed in his executive order) - yet. This summer, Geron Corporation will launch the first clinical trial ever using human embryonic stem cells to treat spinal cord injury.
• A final word on stem cell scams: make sure you ask the treatment provider about the preclinical and clinical research performed prior to using the drug or treatment in the clinic. Was the research monitored or approved by a government agency or hospital review board? Ask to see peer-reviewed studies published in journals. Don't rely on anecdotal information from clinic patients. Get scientific evidence.

Resources

• NIH Stem Cell Information Pages
• FDA Clinical Trial Background Information Pages
• ISSCR Patient Handbook
• ClinicalTrials.gov (FDA clinical trial database)

[sonni57]

on 3/17/2009 Good info on volunteering for stem cell research.