Upon approval of Pluristem’s investigational new drug and investigational medicinal product dossier submissions in the US and Europe, Pluristem plans to initiate Phase I clinical trials by administering PLX-PAD to patients afflicted with critical limb ischemia, who have not responded to traditional medical or surgical interventions.
In connection with these planned clinical trials, Pharmicell will distribute PLX-PAD to the clinical sites at Charite-Universitatsmedizin, and Franziskus-Krankenhaus, both located in Berlin.
Zami Aberman, president and CEO of Pluristem, said: PLX-PAD should be stored in a location close to the clinical sites in Berlin, so it could reach the patients in a timely manner when treatment is required. Collaborating with Pharmicell gives Pluristem the advantage of storing this ready-to-use cell product under stringent conditions in a German regulated facility prior to dispensing it for patient use.
Pharmicell is a biotherapeutics company, which is in manufacturing and banking of sterile cell therapy products. Pharmicell Europe is a subsidiary of South Korea-based FCB Pharmicell, a leading stem cell company in Korea with on-going clinical trials for the use of autologous bone marrow derived stem cells in myocardial infarction and spinal cord injury.
Pluristem Therapeutics is a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products, stored ready-to-use, that are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source.
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