• Press Center
• Press Release Archive
• Media Kit
• SAAAVE Act Campaign
• Press Releases from 2008 Annual Meeting
• JVS Press Releases
• SVS Position Statements
• Contact Us

Home > Press Center > Mononuclear Cells Can Treat

Contact:
Jill Goodwin
Director of Communications
312-334-2308

Critical limb ischemia (CLI) is a serious condition in which the feet and legs have poor circulation with reduced blood flow and lack of oxygen, resulting in pain (even at rest) as well as open sores that do not heal. Despite advances in the surgical and radiological treatment modalities there still more than 120,000 leg amputations in the United States annually due to CLI.

New research indicates that autologous bone marrow transplantation (BMT) may offer hope to those with CLI and have angioneuropathic foot or leg syndrome. Percutaneous or surgical revascularization cannot be used as a treatment in approximately 40 percent of CLI patients because these procedures can result high amputation (22 percent perioperative) and mortality (within one year about 30 percent) rates. This research was presented at the 60th Annual Meeting of the Society for Vascular Surgery.

Bone marrow mononuclear cells contain stem cells, vascular progenitor cells and several other cell types which are needed for the growth of new blood vessels (angiogenesis), thus improving the blood supply of the diseased leg. Theoretically this alternative method has advantages over angiogenic gene therapy or single growth factor transfer, according to lead author Berthod Amann, MD, from the department of internal medicine at Franziskus Krankenhaus Berlin Vascular Center, Germany.

"We studied 15 CLI patients who had been treated with surgical and catheter therapies without any success and faced amputation of the calf or thigh.  Patients were 39 to 85 years of age, with a mean age of 65 years,” said Dr. Amann. “In addition to CLI, seven patients had diabetes mellitus (Type 2) and all had peripheral arterial occlusive disease.”

Twelve patients were aspirated 450-500 ml of bone marrow fluid under general anesthesia from both iliac crests.  The mononuclear cell fraction was isolated via Ficoll™ gradient centrifugation. In the other three patients 120 ml BM was aspirated under local anesthesia and separated with the Harvesttech SmartPrep™ BM centrifuge. 

The BMCN concentrate of about 40 ml marrow cell suspension was then injected deeply in intramuscular 40-50 sites in the ischemic leg and foot. There were no serious procedure-related complications. The mean follow-up time was seven months and limb salvage was achieved in nine patients. The other six patients underwent major amputation. 

In the successfully treated patients new grown vessels improved the blood supply, and angiography six months post-op showed increased small side branches of blood vessels in one-third of patients. Oxygen and blood pressure at the ankle was roughly doubled from the pre-treatment values. Pain-free walking scores were improved in patients and analgesic intake at one month was reduced to 70 percent and at two months it was down to 30 percent of the baseline dose. Granulation of the ulcers occurred in five patients at six weeks.

“We think that bone marrow stem cell transplantation is a safe and very promising new therapy for patients with leg-threatening ischemia,” said Dr. Amann. “We are now testing the efficacy of bone marrow cells for CLI  in a large randomized study. If the results are as encouraging as in our pilot series, we think that many amputations can be avoided.