ST. LOUIS – A clinical trial for patients with critical limb ischemia due to peripheral arterial disease is now enrolling at Mercy Hospital St. Louis, the only trial site in the St. Louis area.
According to the Centers for Disease Control and Prevention, approximately 8 million people in the United States have peripheral arterial disease (PAD). In advanced stages of PAD, blood flow to one or both legs can become severely limited causing a serious condition known as critical limb ischemia, which in severe cases can lead to amputation.
The clinical trial will evaluate the safety and efficacy of an investigational stem cell therapy designed to generate new blood vessels in the lower leg extremities in patients with critical limb ischemia due to PAD. Using Bone Marrow Aspirate Concentrate System (BMAC) from Harvest Technologies, Corp., stem cells from the patient’s own bone marrow are harvested and concentrated and then injected under local anesthesia into the same patient’s affected leg and foot. The main goal of the investigational treatment is to prevent or delay amputation.
The treatment is performed as an outpatient procedure in an operating room using local anesthesia and sedation. This trial is randomized, meaning that not all patients in the trial get the active treatment – one in three patients enrolled will have a placebo injection made from their own peripheral blood.
“Patients with critical limb ischemia can have pain in their feet and legs even when resting; small cuts that don’t heal can result in sores or ulcers,” said Dr. Richard Pennell, Mercy Clinic vascular surgeon and principal investigator for the trial. “The therapy being tested will potentially improve circulation to heal those ulcers and prevent limb amputation, significantly improving the quality of life for these patients.”
Only those patients meeting the predefined approved inclusion/exclusion criteria are eligible for this clinical trial. To learn more about the clinical trial and see the qualifications for participation, visit www.clinicaltrialspotlight.com or call toll-free at 877-547-8839.
Overall, the trial will enroll 210 subjects at up to 50 investigational sites across the US. Subjects over the age of 18 with a confirmed diagnosis of CLI will be randomized to one of two treatment groups at a ratio of two treated with BMAC to one control.
Mercy Hospital St. Louis, part of Mercy’s east Missouri region, is a 979-bed comprehensive teaching hospital. The 80-acre site houses a nine-level heart and vascular hospital, a cancer center, a comprehensive pediatric hospital, a surgery center and a 120-bed skilled nursing center.
Mercy is the sixth largest Catholic health care system in the U.S. and serves more than 3 million people annually. Mercy includes 33 acute care hospitals, four heart hospitals, two children’s hospitals, two rehab hospitals and one orthopedic hospital, 300 outpatient facilities, 40,000 co-workers and more than 2,100 Mercy Clinic physicians in Arkansas, Kansas, Missouri and Oklahoma. Mercy also has outreach ministries in Louisiana, Mississippi and Texas.