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Clinical Trials

Date: 2013-05-13

Type of information: Preclinical data

phase: preclinical

Announcement: results

Company: Pluristem Therapeutics (Israel)

Product: PLX-PAD Cells (Placental eXpanded cells)

Action mechanism:

Disease:

preeclampsia

Therapeutic area: Renal diseases - Cardiovascular diseases - Women health

Country:

Trial details:

Latest news:

* On May 13, 2013, Pluristem Therapeutics, a developer of placenta-based cell therapies, has announced that its PLacental eXpanded (PLX) cells tested in preclinical animal models of preeclampsia effectively improved several parameters of the disease. The study was conducted in collaboration with Brett Mitchel PhD, Associate Professor of Internal Medicine at the Cardiovascular Research Institute (CVRI) of the Texas A&M College of Medicine. Dr. Mitchel will present details of the study on May 30th at the Society for Gynecological Investigation Summit in Jerusalem.
Since preeclampsia is a human pregnancy specific disease, defined as the occurrence of hypertension and significant proteinuria, Dr. Mitchell has established and published two preeclampsia rodent models that exhibits the fundamental features of preeclampsia; pregnancy dependent hypertension and proteinuria. PLX cells administered IM were tested against cell-free medium in these two preeclampsia animal models. Pregnant mice that developed gestational hypertension and proteinuria and received PLX cells demonstrated several positive physiologic, immunologic and histologic findings indicating that PLX cells could be effective in treating preeclampsia.
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.
Pluristem’s is now looking forward to continuing this research with a goal to enter the clinic as soon as possible for this common, potentially lethal disease.
 

Is general: Yes