Physicians In CLI Study Publish Paper On Pluristem's PLX Cells.
HAIFA, Israel, May 15, 2019 -- Placental stem cell company Pluristem Therapeutics Inc. (NASDAQ:PSTI) announced the publication of a peer-reviewed article by physicians conducting the ongoing Phase 3 study evaluating PLX-PAD cell therapy for the treatment of critical limb ischemia (CLI).
The pivotal study is measuring long-term outcomes and collecting parameters to assess the potential economic benefit of this kind of treatment.
Additionally, an invited commentary that also appears in the European Journal of Vascular and Endovascular Surgery supports the study's design and potential impact.
The paper cites the significant need that exists for new and effective CLI treatment options when revascularization is not an alternative, and the shortcomings and differentiation from other therapies that have failed to demonstrate meaningful benefits in controlled clinical studies to date.
Pluristem's PLX-PAD cell therapy has been successfully evaluated in two Phase 1 CLI studies, with additional supportive data from a Phase 2 intermittent claudication (IC) study.
In these studies, PLX-PAD cells have demonstrated a favorable safety profile as well as significant pain reduction, an increase in tissue perfusion, a reduction in surgical events and significant improvement in HbA1c (blood glucose control) and CRP levels (blood test marker for inflammation in the body).
"Several therapies have been tested to meet the medical need of these patients and have not succeeded in demonstrating meaningful benefits to date," said lead author Lars Norgren of Orebro University, Sweden. "From an immunological point of view, it has been shown that treatments using the patient's own cells, and in particular those with cardiovascular risk factors or CLI, are reduced in functionality. One reason Pluristem's PLX-PAD cell therapy is so desirable is that the young healthy placenta cells being used in the therapy are of a better quality and have the potential for higher efficacy than previously seen."
"CLI is a widely recognized disease leading to losses of limbs. With the aging of the world's population, the incidence of this problem continues to increase," said co-author John Lantis of Mount Sinai West. "For these patients who do not have an option for revascularization, and those for whom the risks of intervention outweigh the benefits, we need another option. An intervention focused on office-based injections that could grow new blood vessels could definitely be a game changer for many patients."
The company recently completed enrollment of half of the study's population (n=123).
An interim analysis may be allowed following a 12-month follow-up period and could support an application for conditional marketing approval in Europe, under the European Adaptive Pathways Program.
Citation: Lars Norgren et al., PLX-PAD Cell Treatment of Critical Limb Ischemia: Rationale and Design of the PACE Trial. European Journal of Vascular and Endovascular Surgery, DOI: 10.1016/j.ejvs.2018.11.008
Contact: Lars Norgren, email@example.com
|Printer friendly Cite/link Email Feedback|
|Title Annotation:||Clinical Research|
|Publication:||Stem Cell Research News|
|Date:||Jun 3, 2019|
|Previous Article:||Noninvasive Tool Monitors Stem Cell Transplantation.|
|Next Article:||Data From Athersys' ARDS Clinical Trial Presented At Meeting.|