Pluristem's PLX Cells One Step Closer to Entering Japan's Accelerated Pathway for Regenerative Medicine
Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) agreed with the proposed quality and large-scale manufacturing methods for PLX-PAD cells for use in clinical trials. This agreement is an important milestone for initiation of a Phase I/II study in critical limb ischemia through Japan's Accelerated Pathway for Regenerative Medicine. The new regulatory pathway could potentially significantly reduce time to market for cell therapies such as PLX cells.
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