Early stage stem cell therapy company Arteriocyte Inc. has a lofty ambition: to one day develop allogeneic stem cells from umbilical cord blood that can be used to trigger new blood vessel growth in patients with vascular disease.

Until that is achieved, the company, a January 2004 spinout of Case Western Reserve University in Cleveland, is focusing on adult-derived autologous stem cells, and recently began a Phase I safety trial in patients suffering from chronic ischemia.

Three of 10 patients have completed treatment to date, and the fourth patient is set to start soon, said Arteriocyte CEO Don Brown.

"We hope to have all 10 patients treated by the end of May," he said, adding that the company anticipates meeting with the FDA for a pre-Phase II meeting sometime during the third quarter.

Treatment in the Phase I trial involves harvesting about 200 cubic centimeters of bone marrow from the patient’s iliac crest, then purifying that population to obtain an enriched cell population, which will be flushed into the collateralized bed through a cardiac catheter.

The therapy is designed to facilitate angiogenesis and repair blood vessels damaged by coronary artery disease.

Arteriocyte is based on technologies developed by company founders Mary Laughlin and Vincent Pompili, members of the Case School of Medicine faculty, as well as Steven Haynesworth, associate dean of Case’s College of Arts and Sciences.

Over the last two years, the company in-licensed additional technologies from the University of Minnesota and Stanford University.

Brown said the company’s approach to harvesting stem cells is "distinctly different."

"Other companies go after significant ex vivo expansion of a cell line or cell population, but our view is that you can actually get a therapeutic unit out of marrow harvest or one umbilical cord unit," he said.

Though scientists initially thought that stem cells, when injected into damaged tissue, would engraft to that tissue the same way stem cell transplants do in leukemia patients, it has been proved that improvement in patient function occurs more quickly than the actual engrafting, he said.

"So something else is happening," he told BioWorld Today, adding that results indicated that "the purified cell population comes into an area of damaged tissue and jumpstarts the body’s own repair mechanism."

Arteriocyte is concentrating on patients with chronic conditions, although it might look at therapies for acute settings later on. Other areas of interest include peripheral vascular disease, stroke and renal ischemia.

"Our goal is to initially use autologous [stem cells] and move eventually into allogeneic umbilical cord-derived cells," Brown said. Umbilical cord stem cells "have demonstrated an ability to deliver equivalent, if not better, angiogenic properties," due mostly to the absence of any age-related degradation.

An estimated 4 million are discarded in the U.S. every year, so there’s no shortage of resources.

"The burden of proof" is whether "an allogeneic-derived stem cell [will] live long enough in an immune-competent patient to deliver the same therapeutic benefit," Brown said, and whether "short-term administration may be sufficient to get the repair mechanism going."

To date, the company has received about $250,000 in seed money from Case Technology Ventures, plus a $1.4 million Small Business Technology Transfer grant from the National Institutes of Health in Bethesda, Md., to fund its Phase I trial.

Depending on the safety data from that trial, "we anticipate doing a Series A round later this year," Brown said.

The company has six employees and relies on outside consultants for much of its clinical work. The company has research agreements with University Hospitals of Cleveland.

In separate news, Stem Cell Innovations Inc. presented data Wednesday demonstrating the ability to produce multiple lines of human pluripotent stem cells derived from fetal tissue.

Scientists from the Scotch Plains, N.J.-based company showed that they were able to overcome many of the problems inherent in the production of those cells, known as embryonic germ (GE) cells. The company is able to maintain the state and normal chromosome complement of the cell lines, and also produce cell lines without feeder layers.

Those data were presented at the Keystone Symposium on Stem Cells in Vancouver, British Columbia.

Since GE cells are not derived from early embryos, work can be funded by the NIH.