These findings included:
- A progressive, significant (p<0.05) reduction of systolic blood pressure to the level of normal pregnant mice within 3 days of PLX cell administration. Additionally, PLX cells had no effect on blood pressure when given to normal pregnant mice.
- Significant (p<0.05) reduction of urinary protein excretion to levels seen in normal pregnant mice within 4 days after PLX cell administration. Additionally, PLX cells had no effect on urinary protein excretion when given to normal pregnant mice.
- Significant (p<0.05) increase in endothelial function (as measured by acetylcholine-induced relaxation) to levels seen in normal pregnant mice within 4 days following PLX cell administration.
- Significant (p<0.05) reduction in the weight of the spleen to levels seen in normal pregnant mice within 4 days following PLX cell administration. Additionally, PLX cells did not increase the spleen size in pregnant mice demonstrating the lack of immunogenicity of these cells.
- No significant differences in the number of pups per litter or fetal demise per litter was observed for all groups suggesting PLX cells do not harm the fetus.
Dr. Mitchell stated, "We were pleasantly surprised that a one-time treatment with PLX cells during pregnancy was able to safely and effectively normalize blood pressure and kidney function in mice with experimental preeclampsia. Our preliminary results suggest that the factors secreted by these cells were able to restore endothelial function while having no deleterious effects on the mother or the fetuses. Since there are currently no treatments for preeclampsia, we are hopeful that women with PE will soon benefit from this promising cell therapy."
Zami Aberman, Chairman and CEO stated, "While specific mechanisms remain to be determined, this preliminary data demonstrating that Pluristem's PLX cells are a potential novel therapeutic for the treatment of preeclampsia is very exciting. We look forward to continuing our research with a goal to enter the clinic as soon as possible for this common, potentially lethal disease that currently has no acceptable treatment."
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