PSTI’s meeting with the Paul Ehrlich Institute (PEI), the German regulatory authority for advanced therapy products (ATP) allows designing 2 Phase IIb clinical trials Read more…
PSTI announced (4/26/10) interim results from its Phase I clinical trial utilizing its placenta-derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). A total of 21 patients, representing 77% of the cohorts required to complete the Phase I dose-escalating studies in the US and Germany have been dosed with PLX-PAD. This includes 15 patients dosed in Germany, representing the complete patient enrollment in that country.
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PSTI (3/2/10) received approval from an independent Data Safety Monitoring Board (DSMB) to advance its placenta-derived cell therapy product, PLX-PAD.
- This Phase I study in the EU is to evaluate the safety of PLX-PAD for 3 dosing levels in 15 patients for the treatment of Critical Limb Ischemia (CLI), the end-stage of peripheral artery disease (PAD).
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Pluristem Therapeutics (NASDAQ: PSTI) is engaged in the production, research and development of placental-derived adherent stromal cells (ASCs). PSTI commercializes non-personalized (allogeneic) cell therapy products for the treatment of various severe degenerative, ischemic and autoimmune disorders. Focus: PSTI develops a pipeline of products that are derived from the human placenta, a non-controversial, non-embryonic, adult stem cell source. These placental adherent stromal cells (ASCs) are expanded in proprietary PluriXTM 3 dimensional bio-reactors; which imitates the natural micro-structure of bone marrow and does not require supplemental growth factors or other exogenous materials. Read more…