Treatment of Buerger’s Disease Patient
Buerger’s disease is a severe vascular inflammatory disease associated with high risk of amputation
Patient was at a pre-amputation stage and was treated with PLX-PAD cell therapy under compassionate use treatment
After a 12 month follow up period, PLX-PAD restored peripheral blood supply to the injured limb and prevented amputation
PLX-PAD was granted Orphan Drug Designation by the FDA for the treatment of Buerger’s disease and an expanded access program for the treatment of critical limb ischemia
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative-medicine company developing novel placenta-based cell therapy products, recently reported a successful one-year follow up of a compassionate use treatment in a Buerger’s disease patient treated with Pluristem’s PLX-PAD.
The thirty-six years old patient, who was diagnosed with Buerger’s disease approximately four years ago, displayed painful, non-healing ulcers on his foot. Available medical interventions, including revascularization procedures, were unsuccessful in restoring sufficient blood flow to the affected limb and the patient progressed to a pre-amputation stage.
Following his physician’s request and regulatory approval, patient was given a compassionate use treatment of PLX-PAD cells, consisting of two administration to the foot and calf, approximately eight weeks apart.
“The patient was in an advanced stage of Buerger’s disease and was facing amputation,” said Prof Boris Yoffe, Department of General and Vascular Surgery at the Barzilai Medical Center in Israel. “Following treatment with PLX-PAD cells, we observed demonstrable restoration of the patient’s peripheral blood supply to the injured limb, which was manifested by a significant improvement in color, warmth, wound size and reduced pain. One year following treatment, the wound is now fully closed, the patient was able to resume normal activities and amputation was prevented.
This treatment highlights PLX-PAD’s ability to reduce inflammation, stimulate growth of new blood vessels and support treatment in ischemic conditions such as Buerger’s disease and Peripheral Arterial Diseases (PAD). Additionally, the other limb, which was in earlier stages of the disease, also showed signs of improvement demonstrating the cells’ ability to prevent progression of the disease and act as a potential systemic treatment. I am highly encouraged by these results providing hope for Buerger’s disease patients and am happy to see the significant improvement in the patient’s medical condition, quality of life and overall wellbeing.”
“The positive outcome experienced by the patient reflects what we believe is the broad potential of PLX-PAD in treating a wide range of vascular and inflammatory conditions, where improved treatment paradigms are surely needed,” said Zami Aberman, Chairman & Co-CEO of Pluristem. “While we advance PLX-PAD in our ongoing multinational Phase III clinical study in critical limb ischemia (CLI), we are pleased to see more supportive evidence of patients benefiting from our PLX regenerative agents. We are now enabling access to PLX-PAD treatment through our U.S. Expanded Access Program in CLI and will explore to expand the program to include Buerger’s disease patients.”
Buerger’s disease (thromboangiitis obliterans) is a recurring progressive inflammatory disease resulting in clotting of small and medium size arteries and veins of the hands and feet. The specific cause of Buerger’s disease remains unknown. The risk for developing Buerger’s disease increases with heavy smoking. There is no cure available today for Buerger’s disease.
The initial symptoms of Buerger’s disease often begin with claudication, progressing to pain at rest. If the condition is severe, complications like gangrene may accrue which may lead to limb amputation. PLX-PAD has been granted Orphan Drug Designation by the FDA for the treatment of Buerger’s disease.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.