Dr. Graham Creasey, Stanford University Medical Center

Talking about Amanda Barksdale (?) a paralyzed skier who came to him in 2000 for a bladder issue (if you're a ski instructor and you become wet at the top of the mountain, you'll be frozen before you get to the mountain)

Recently she came to me and said she was going to India to get a stem cell transplant. I strongly advised her not to go. How could she make an informed decision?

We all need so much more information about these offshore trials.

Amanda allowed me to share some of the data we collected about her condition.

She's been to India 3 times in the last year or so, and is going back again in 4 months. She gets a variety of stem cell injections and physical therapy. The results have been very difficult to quantify; one big problem is that we just don't have good outcome measures. Amanda herself is convinced that she is getting return -- but the measures we have don't show it in a significant or lasting sense. (He has slides up to show exactly what sensory changes they tried to measure; check the webcast)

Later someone asks what Amanda believes to have been the benefits she's gained . . . Dr. Creasey answers that the main thing she says is that it's added hope to her vocabulary.

So, if you're thinking about getting an experimental trial for a spinal cord injury, here are some questions to ask:

1. how safe is it? if they say 100%, don't go any further
2. what benefits can be expected?
3. what evidence is there for those benefits?
4. what is the study design? is there a control group? is there a chance that i'll be in it?
5. if i take part in this study, will i be excluded from other studies later?
6. what does it cost, and if this is research, should i be paying?
7. has this particular intervention been reviewed by other people?

all these are reasonable questions, and deserve reasonable answers.

There is now a partnership of associations developed to create some standard outcome measures, so that we will have some common language and strictly defined measuring sticks to know what outcomes actually are. One reason this matters is that it will help us build a network of people ready to participate in a network of clinical trials-- a huge win if it happens.