Date: 2012-08-16
Type of information:
phase: 2
Announcement: authorization of a phase 2 clinical trial
Company: Pluristem Therapeutics (Israel)
Product: PLX cells (PLacental eXpanded cells)
Action mechanism: The PLX cells are mesenchymal-like adherent stromal cells (ASCs) derived from full term placenta. The cells are expanded in the company\'s proprietary bioreactor system, which provides a three dimensional (3D) microenvironment that enables full control over the manufacturing process, large-scale growth of these cells and batch to batch consistency. PLX cells are immune privileged and possess immunomodulatory properties.
Disease: thromboangiitis obliterans (Buerger\'s disease)
Therapeutic area: Rare diseases - Inflammatory diseases - Cardiovascular diseases
Country: India
Trial details:
Latest
news: Pluristem Therapeutics, a developer of placenta-based cell therapies, has received permission from the Indian Ministry of Health to proceed with a Phase II clinical trial for the treatment of thromboangiitis obliterans (Buerger\'s disease). This Phase II trial will be potentially followed by a larger multi-national Phase III study in the U.S., Europe and India.
Last August, the FDA designated Pluristem’s PLX cells orphan status for the treatment of Buerger\'s disease, a severe disease affecting the blood vessels of the extremities (See http://biopharmanalyses.fr/product/?pageid=293). The disease is a recurrent, progressive inflammation and clotting of the small and medium arteries and veins of the hands and feet. Severe pain and ulcers of the extremities may occur, which may lead to amputation.
