On Thursday, August 29, Saint Joseph’s Hospital performed the Southeast’s first adult stem cell implant in a patient with Chronic Limb Ischemia (CLI) in an effort to prevent limb amputation. The clinical trial for CLI, a serious condition that involves blocked arteries to the legs, is being conducted at Saint Joseph’s Hospital, in coordination through Saint Joseph’s Research Institute, and is the only hospital participating in the study in the region.
The promising, new stem cell research study may spare patients the devastating loss of their legs by amputation because of diseases such as diabetes. Because of the blocked arteries, CLI patients have a much lower blood flow to the limbs which can progress to severe pain, ulcers, sores, and amputation.“This study is the only one of its kind currently enrolling patients and offers tremendous hope to those patients who face imminent loss of a limb due to diabetes or other disorders,” says Nicolas Chronos, MD, chief medical and scientific officer of Saint Joseph’s Research Institute. “The results of this trial could improve the quality of life for many people while eliminating or reducing hospitalizations and associated medical costs.”
The patient, a 68 year old male (and patient of Jorge Zarge, vascular surgeon at Saint Joseph’s) suffers from severe ischemia as the result of several heart attacks and other cardiovascular problems. The study involves using the patient’s own adult stem cells from bone marrow extracted from the hip, which are then cultured and implanted directly into the damaged area of the leg. When studied in preclinical models, adult stem cells stimulated blood vessel growth resulting in restored blood flow to the leg, saving it from amputation. Results are expected within three months. It’s estimated that 750,000 patients in the United States have CLI, and more than 200,000 patients face amputation every year.
While medications can prevent CLI from worsening, interventional surgery is required to open blocked arteries and restore blood flow. Unfortunately, some surgeries fail within a year and many patient’s are not good candidates for surgery because of the complexity of their illness. For those patients, amputation is their only option. This study may offer those patients a better choice.
Saint Joseph’s is participating in the trial along with at St. Luke’s Episcopal Hospital, Texas Heart Institute, Duke University and Indiana University. A total of twenty patients will be enrolled in the trial and monitored for up to six months with a primary endpoint in three months. Endpoints include safety and the ability of therapy to reduce rest pain, increase skin surface oxygen pressure and improve ulcer healing.
For more information regarding this research study, please contact Saint Joseph’s Research Institute at 404-843-6080 or
www.sjri.org.
