Japan Grants Safety Clearance to Pluristem's PLX-PAD Cells for Use in Clinical Trials
Pluristem Therapeutics Inc, a leading developer of placenta-based cell therapy products, announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has cleared the Company's PLX-PAD cells for use in clinical trials in Japan. This clearance is required in order to apply for approval to conduct a Phase II study of PLX-PAD in critical limb ischemia (CLI) through Japan's accelerated regulatory pathway for regenerative medicine. This regulatory pathway generally allows for conditional, time-limited marketing approval after a single successful Phase II...
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