Pluristem Therapeutics has closed enrolment for its Phase II trial of placental expanded (PLX-PAD) cells to treat intermittent claudication (IC), a peripheral artery disease (PAD). Patient enrolment was conducted at 30 clinical sites in the US, Germany, South Korea, and Israel. The Phase II trial will be conducted to determine safety and efficacy of PLX-PAD cells compared to placebo to treat IC. IC is caused due to deposition of fats in the arteries of legs and leads to symptoms such as muscle pain, cramps, numbness or a sense of fatigue, usually in the calf muscle, which occurs during walking or similar exercise. The firm completed enrolment of 172 people. Pluristem's IC trial is evaluating the safety and efficacy of PLX-PAD cells as compared to placebo. Both were administered via intramuscular injections in 172 patients with IC, Fontaine class IIb, Rutherford category 2-3. The primary efficacy endpoint is the change in maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints include hemodynamic and quality of life measurements. Safety parameters are also being assessed. The prevalence of IC in the US alone is approximately 14 million patients, representing a cost of approximately $2.5 billion annually to the national healthcare system.