Stem cell therapy developer Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT) said that two Phase I clinical trials showed that its PLX-PAD placenta-derived cell therapy is safe and improves quality of life.
The trials studied 21 patients with critical limb ischemia, the end stage of peripheral artery disease. The results of the clinical trials allow Haifa-based Pluristem to select the target treatment dose of PLX-PAD for additional studies focused on the cell therapy’s efficacy.
The studies were designed to evaluate the safety of PLX-PAD cells and included accessing the patient’s immunological profile before and after the local administration of PLX-PAD. In addition, efficacy parameters were assessed and five different doses of PLX-PAD were evaluated.
The trials were conducted at Duke University Medical Center, Stanford University Medical Center, the Center for Therapeutic Angiogenesis in Birmingham, Alabama and St. Franziskus Hospital.
Results included the findings that PLX-PAD cells can be administered safely as an “off-the-shelf” product without a need for matching between donor and patient. Additionally, efficacy was demonstrated across all doses with a statistically significant improvement noted in the pain score and quality of life.
PLX-PAD cells are derived from human placenta, a non-embryonic, adult stem cell source.
Pluristem shares closed yesterday at $1.15, giving a market cap of $24.04 million.
Published by Globes [online], Israel business news - www.globes-online.com - on September 15, 2010
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