Trials & Filings

MFDS Clears Pluristem for IC Trial

Fourth country added to multinational trial

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Pluristem Therapeutics has received approval from the South Korean Ministry of Food and Drug Safety (MFDS) to conduct a Phase II study using PLX-PAD cells for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD). The IND approved by the MFDS mirrors INDs already approved by regulators in the U.S., Germany and Israel. South Korea will be the fourth country participating in this multi-national trial involving the use of PLX-PAD in IC. CHA Bio&Diostech C...

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