Although, no differences in repair tissue were observed at the 20-month end point of the study, the main advantage of these cells over full-depth chondrocytes is the ability to generate very large cell numbers that retain their phenotype, from a single cell.
After the infections with GI.3 and GII.4, serum antibody levels to both VLPs measured at 18 months increased 16 times (end-point titers 51,200 and 102,400, respectively) compared to the pre-infection titers at 12 months (end-point titers 3200 and 6400) (Fig. 1).
The primary outcome was the frequency of episodes of self harm over a defined period (12 months before baseline, 6 months before 6 month assessment, 6 months before end point).
Interestingly, there was no significant difference between treatments in the median progression-free (6.5 vs 6.7 months; primary end point) and overall (13.7 vs 13.8 months) survival after a median follow-up of 15 months.
Reduction in 24-hour ambulatory systolic blood pressure will be assessed at 3 months (primary end point).
The percentage of patients achieving the SBP target significantly increased from baseline to 12 months (secondary end point) in both benchmarking (27.3 40.0%; P < 0.001) and control (27.1 30.1%; P = 0.043) groups.
The percentage of patients achieving HbA1c target significantly increased from baseline to 12 months (secondary end point) in both benchmarking (49.2 58.9%; P < 0.001) and control groups (55.0 62.1%; P < 0.001), with a greater increase in percentage of patients reaching the HbA1c target in the benchmarking group.
Based upon data from a non-randomized, but controlled study from Sweden, a 10-point change in KOOS-ADL (SD of 18.5 pre-surgery and 10.4 post-surgery) has been selected as clinical important difference at the 3-months end-point.
The median follow-up was 30 months for the stool samples (range 9 37 months), with median end point (autoimmunity) of the cases at 20.5 months (range 6 43).
We defined ΔGA/HbA1c as the difference between the nadir point (at 15 to 27 months) and the end point (at 39 to 51 months) and found that ΔGA/HbA1c was positively correlated with diabetes duration and negatively related to beta-cell function.
