Updated on 22 December 2015
Pluristem Therapeutics Inc., Israel's developer of placenta-based cell therapy products, has reached an agreement with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) on the design of the final trial needed to apply for conditional approval of PLX-PAD cells in the treatment of critical limb ischemia (CLI).
The approval of the protocol for the 75-patient trial was part of a larger agreement on the development of PLX-PAD via Japan's new accelerated regulatory pathway for regenerative medicine.
"With this achievement we have advanced our strategy to expedite commercialization of our cell products. Pluristem is now positioned favorably to accelerate negotiations with those Japanese pharma companies interested in becoming dominant players in the expanding regenerative medicine market in Japan," stated Pluristem Chairman and CEO Zami Aberman.
The trial will collect data on 75 patients suffering from CLI. These patients will be randomized into three groups of 25. Group one will receive an initial 150 million PLX-PAD cell dose followed eight weeks later by a second 150 million cell dose; group two will be treated with an initial 300 million PLX-PAD cells followed eight weeks later by a second dose of 300 million cells; group three will receive two doses of placebo.
The cells will be injected into a leg muscle using a standard syringe. Efficacy and safety will be determined from outcomes measured nine months after administration of the first dose.