Angiographic Change After Injection of Beperminogene Perplasmid, a Hepatocyte Growth Factor Gene Therapy Product for the Treatment of Critical Limb Ischemia.

Beperminogene perplasmid (BP) is a hepatocyte growth factor gene therapy product that has angiogenic activity. There are no reports on angiographic changes after BP injection in patients with critical limb ischemia (CLI). Here, we report on angiographic changes after treatment of CLI with BP.

A 62-year-old woman who, for the previous 2 years, had had atherosclerotic non-healing ischemic ulcers on the left heel that were not responsive to endovascular treatment was started on BP injections. BP injections were administered 3 times every 4 weeks. In each session, BP was injected at 8 sites (0.5 mg per site) in the left soleus muscle under ultrasound guidance. Lower extremity angiography (; ) showed neovascularization. The wound healed (), and left plantar skin perfusion pressure improved from 20 to 53 mmHg. There were no other changes in medical treatment related to wound healing or off-loading devices. This is the first observation of an angiographic change associated with BP injection in a patient with CLI.

Figure.

(A) Lower extremity angiography (LEA) before beperminogene perplasmid (BP) injection showing occlusion of the posterior tibial artery (arrow). (B) LEA after BP. Small vascular vessels (arrowheads) are growing from small branches of the tibial and peroneal arteries (arrow). Both angiographies were performed following injection of 24 mL iodixanol contrast agent through the left common femoral artery at a rate of 3 mL/s. BP was injected intramuscularly in the borderline area of ischemia, thereby increasing the number of blood vessels in this area, as shown by LEA. (C) Non-healing ischemic ulcers of the heel. (D) The wound healed after 9 months.

Disclosure

The authors report no financial relationships or conflicts of interest regarding the contents of this manuscript.

IRB Information

This manuscript was approved by Kyoto Daiichi Red Cross Hospital Ethics Committee (Reference no. 1368).

Supplementary Movie. Lower extremity angiography (LEA) before and after beperminogene perplasmid (BP) injection, showing wound blush around the left heal after BP injection.