Saturday, April 23, 2011

Studies happening in the states

There are two clinical trials happening in the states with umbilical cord stem cells thus far.  One at the Medical college of Georgia and the other at Duke. (this makes reference to both studies)

What is a Clinical Trial?
A clinical trial is a research study designed to answer specific questions about a new treatment or a new way of using current treatments. Clinical trials are used to establish whether new treatments are safe and effective. It is very important to understand that the new treatment being tested is unproven. It may not be better than, or even as good as, existing treatments.

Some research studies are not trials. In some cases, new experimental treatments might be tried on a very small number of people before a clinical trial is started. Again, the new treatment being tested is unproven.
The fact that a procedure is experimental does not automatically mean that it is part of a research study or clinical trial. Experimental procedures should be made part of a formal research study at an early stage in order to determine whether they are safe and effective

Why is Lila not able to be part of a Clinical Trial in the US?
The down side to these studies is that they both require the child's own stem cells.  As most of you know, we have Lila's sisters stem cells stored for Lila's use.  I have spoken with both of these doctors piloting these studies, and they have both said that it will be at leas another two years before these studies are done, and then another two to four years before they have funding to begin a sibling to sibling trial.  So, if we waited for them to come along in the States, Lila would be anywhere from 10-12 years of age before we would even be able to take advantage of a trial that may (or may not) happen. (story about the Duke professor running the trial)
A child who was part of the study at Duke.  We have also talked personally with two other parents whose children participated in the Duke study, and have seen major improvements!  One child was going to be held back in Pre-K, recommended by his Mom, but the teacher said that his cognitive level had met and/or surpassed his peers, and he was more than ready for the regular kindergarten class following his treatment! (story about the Medical College of Georgia and the 1st FDA approved study using umbilical cord cells in some patients and a placebo in others)

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