ALSFRS R and MRC shared a similar deterioration pattern reaching down to 50 and 40% (resp.) of their initial value within 21 months of observation.
The values of three functional tests, which separately assessed the upper limbs, lower limbs, and the trunk, decreased faster and earlier than ALSFRS R.
No differences in the progression rate of ALSFRS R was found between the pre- and posttransplantation observation period (Figure 5).
When adding age limit, functional stage according to ALSFRS R, and the reduced FVC, the number of patients potentially eligible for a stem cell clinical trial dropped dramatically.
The present study found a mean decline on the revised ALSFRS
of 1.6 points during the control period and of 3.4 points during the training period.
As expected, patients' functional status decreased significantly (z = -2.81; p < .01) from T, to [T.sub.2], with average ALSFRS
scores of 18.16 [+ or -] 12.03 and 15.89 [+ or -] 12.09, respectively.
The average ALSFRS score for responders at 9 months after treatment was 37.
As measured by an average slope of decline of ALSFRS, responders' disease progression was -0.007 point per day, while non-responders' disease progression was -0.1 per day, which was again statistically significant.
Fifty percent had an improvement in the slope of the ALSFRS score, and 67 percent had an improvement in the slope of the percent-predicted FVC.
NurOwn slowed the progression of ALS, as indicated by an improving slope of both the mean ALSFRS and mean FVC curves after therapy.
On ALSFRS, NurOwn slowed the rate of progression by 45 percent, from 1.41 points per month during the run-in period to 0.78 points per month for the three months following treatment, and by 57 percent to 0.60 per month for the six months following treatment.
"I am impressed by the consistency of benefit of IT administration we have seen in both studies, and we saw in this study that almost every subject experienced clinical benefit, either on ALSFRS, FVC or both measures.