Stem Cells Help Treat Heart, Leg Blockages on Louisiana Medical News

Stem Cells Help Treat Heart, Leg Blockages

By: TED GRIGGS

A small, privately held Covington laboratory is breaking new ground in treating heart disease and limb ischemia with adult stem cells.

TCA Cellular Therapy has completed or is in the process of completing Phase I or Phase II clinical trials that include repairing heart muscle damaged in heart attacks as well as treating severe leg and coronary ischemia.

In late March, TCA medical director Dr. Gabriel Lasala presented the preliminary findings of the severe limb ischemia Phase I trial at the American College of Cardiology's annual i2 Summit.

"These are patients with severe blockages in the legs who are not candidates for bypass, stents or anything," Lasala said. "Most of these folks are people who were going to have an amputation of the leg. They can't walk. They've got gangrene, things like that. They're in bad shape."

The trial included 10 patients and all demonstrated significant recovery, Lasala said.

TCA's successes include Penny Kibideaux, who was scheduled for a leg amputation when her physicians sent her to Lasala. Kibideaux received a stem cell infusion in November and a few weeks later was able to walk through malls to do her Christmas shopping.

Lasala said the difference between TCA's approach and others is that TCA uses two different kinds of stem cells in treatment, in this case the patient's own endothelial progenitor cells and mesenchymyal stem cells.

TCA takes bone marrow from the patients' hips and multiples the stem cells in incubators in its lab, which Lasala said is Louisiana's only GMP, or Good Manufacturing Practices, stem cell processing facility. The cells are then mixed and infused into damaged veins.

Lasala said TCA's scientific director, Jose Minguell, PhD, came up with the idea for combined stem cell therapy. His hypothesis is that the complex process of forming mature blood vessels involves several types of cells, including smooth muscle cells, and growth factors. Unless all of the components are available, the blood vessels will not form properly and will be unable to deliver the appropriate blood supply to the leg.

"To Dr. Minguell, it did not make any sense to use what they call serum 34 cells, which is hematopoietic stem cells, to create muscle because they are not muscle precursors," Lasala said.

Researchers have tried this approach over the last several years, the thinking being that the cells will change and become muscle, Lasala said. But research has shown this does not happen, the hematapoietic cells do not become muscle.

TCA has also applied its technique in a Phase I trial for patients with severe coronary artery disease, patients so ill that operating is not an option, Lasala said. Lasala presented the preliminary results of that trial at the International Conference on Cell Therapy for Cardiovascular Disease in New York in January.

Phase II trials for both limb and coronary ischemia are nearing completion, and Lasala said he expects to present the results of both trials by the end of the year.

TCA is also designing protocols to treat neurological diseases such as spinal cord injuries, Parkinson's disease and Amytrophic Lateral Scelerosis, also known as Lou Gehrig's disease. The company is seeking the U.S. Food and Drug Administration's approval to use stem cells to treat ALS and anticipates new uses for the treatment in other cardiac diseases, such as idiopathic cardiomyopathy, which leads to weakened and often enlarged hearts.

Meanwhile, Lasala said TCA will need to raise money from private investors or through research grants in order to perform Phase III ischemia trials.

Those trials are very expensive and involve 400 or 500 patients, he said.

"There's no way we can do that, but the results are spectacular compared to any results that anybody has published," Lasala said. "So we're very positive about what we have, and we hope that some foundations will help us raise some capital or investors will want to get involved and put some capital in."

All of TCA's investors are doctors, Lasala said.

The company is pursuing two strategies to raise money. TCA is forming a tax-exempt organization, or 501(c)(3) corporation, that can raise money to fund the most expensive part of the Phase III study, Lasala said. The charitable foundation can raise the capital needed to pay for patients' treatment.

The second approach will be to try to raise capital from investors, Lasala said. The government of Dubai has approached TCA and talked about buying 51 percent of the company, Lasala said. That would eliminate any funding problems.