July 8, 2003
Boston Cure Project
Results from another MS stem cell transplant trial (this one conducted by Northwestern University) suggest that subjects with advanced disability may not benefit greatly from this radical experimental treatment. As in previous studies of this nature, subjects were chosen based on a recent history of progression (at least 1.0 to 1.5 EDSS points in the past year) as well as nonresponsiveness to interferon and steroid therapy. Of the 21 subjects enrolled in this study, 12 had pre-treatment EDSS scores of 6.5 or more. Monitoring in the months and years following treatment showed that 8 of the 12 progressed by one or more EDSS points, 2 progressed by 0.5 points and 2 were unchanged. (Two of the 8 died more than a year post-treatment from complications related to progressive neurological deterioration.) Of the 9 subjects with initial EDSS scores of 6.0 or lower, 6 progressed by half a point, 2 remained unchanged, and one (the only participant with relapsing-remitting MS) actually improved by 2.5 points.
No control group was used so it is unclear how the participants' outcomes compare with their untreated peers. However, based on average progression rates, the authors assert that the higher-EDSS group as a whole progressed more quickly than expected. This may be due to a bias in selecting participants for the trial or to an actual acceleration of axonal injury by the treatment process itself. The authors also suggest that intense immune suppression might not work as well in those subjects for whom axonal degeneration and not immune activity is the key disease mechanism.
One important point with respect to the group with lower pre-treatment
EDSS scores is that these subjects entered the study later and were not
followed after treatment as long as the higher-scoring EDSS subjects (there
was an average 1 year of follow-up for low-EDSS subjects vs. 2.6 years
for the higher-EDSS group). Therefore, although the preliminary data suggest
that the lower-EDSS group tended to stabilize, only longer-term follow-up
will tell to what extent this benefit is maintained over time.
Copyright © 2003, Boston Cure Project