He was referred to a new experimental stem cell procedure that a private research company was conducting. TCA Cellular Therapy located in Covington's Lakeview Regional Medical Center had recently received U.S. Food and Drug Administration (FDA) approval to begin Phase I testing involving human test subjects to treat leg ischemia. No longer able to benefit from other treatment possibilities, Wert was a suitable candidate and he became one of 10 people on whom TCA would perform this state-of-the-art protocol.
In laymen's terms, the procedure sounds fairly simple. A TCA nurse draws bone marrow fluid from a subject's hip; the fluid is taken to a laboratory where technicians separate out healthy stem cells, approximately 1,500 cells. These stem cells are then expanded, or multiplied, in a cell culture over the course of 20 to 30 days until the original 1,500 stem cells became 30 to 40 million cells. Even with 30 to 40 million stem cells, this only amounts to two c.c.s of fluid, or a half a teaspoonful, and this is put into a syringe and then injected into the calf muscle.
Dr. Jose Minguell, a leading researcher in the field of stem cell research and scientific director of TCA, says that adult stem cells are multi-potent, meaning they have the ability, unlike other human cells, to change, or differentiate, into other cells.
"The concept is when you put these stem cells into the muscle, the stem cells have the capacity to differentiate into new blood vessels," Minguell explains. "We use a combination of (stem) cells that make not only new blood vessels, but the quality of these new blood vessels is good. The new blood vessels will last in the patient for a long time."
Dr. Gabriel Lasala, a cardiologist and president of TCA, performed the surgical procedure on Wert on Dec. 12. Following the infusion, Wert says he noticed a change almost immediately: color returned to his legs, he could walk further and he was experiencing much less pain. The other nine patients that have received the stem cell treatments have also reported vast improvement in their leg ischemia. Rosalie Kibodeaux was relegated to a wheelchair and was scheduled to have her leg amputated below the knee. Now, blood is circulating to her leg and she can walk.
It's these kinds of stories that make TCA Cellular the best-kept medical secret in the metro area.
"We're so private, the hospital's PR staff didn't even know we existed," says Vicki Nicely, TCA's administrative director. Nicely, Minguell and Lasala are the principal owners of TCA and the driving force behind a company that Lasala says is "ahead of the world" in terms of adult stem cell therapy.
While the public debate continues over the ethical use of embryonic stem cells, the FDA has been approving a number of Phase I protocols for therapeutic use of adult stem cells. Typically, these tests are conducted by universities or a university partnering with a private company due to upfront costs testing organizations have to bear all expenses and because of the high number of researchers available at academic institutions. TCA is an anomaly: it occupies a single floor in the medical office building of the Lakeview medical center, has no university affiliation, has only 10 employees, and, yet, it currently is carrying out four different Phase I stem cell testing protocols.
By selling some of the private shares in the company, TCA can afford the operating expense of testing protocols. And while the TCA brain trust is limited to just 10 people, Nicely, Minguell and Lasala each bring significant expertise in the area of adult stem-cell research. Nicely has extensive experience in the regulatory and administrative processes required for FDA applications, and it is up to her to ensure TCA applications are filed properly and followed up on. Lasala has been involved with research since 1981, and as a clinician who performs the procedure, is the primary investigator in the four experimental protocols.
While Nicely and Lasala are vital partners in the TCA team, they likely wouldn't argue with the notion that Minguell is the most valuable player. As a cellular biologist, Minguell has been researching adult stem cells for many years and was, until 2006, the director of the department of cellular therapy at the Universidad de Chile in Santiago, Chile. Lasala, who has been collaborating with Minguell since 2002, says that the U.S. is behind other countries when it comes to stem cell research and adds that numerous governmental regulations and restrictions have made progress difficult. In order to jumpstart TCA's investigations, Lasala decided it was necessary to recruit talent from outside the U.S.
"This is the elite of stem cells," Lasala says. "There's a doctor in China, two doctors in Europe and Dr. Minguell in South America. And we got Dr. Minguell here."
When he arrived in Covington, Minguell brought with him his U.S. patent for isolating adult stem cells (in this case mesenchymal stem cells) from bone marrow. The patent coupled with his knowledge of how to multiply the stem cells in vitro meant Minguell could extract the cells and multiply them in the TCA laboratory, allowing him and Lasala to focus on developing ways to use the stem cells therapeutically.
With heart disease as the leading cause of death in the United States and Lasala specializing in cardiology, it follows that three of the four TCA protocols involve treating patients suffering from cardiac ailments. In each of these protocols one is for heart attack victims, one is for heart-bypass surgery patients and the other for those with severe cardiac ischemia or coronary blockage the patient will receive an injection of their own healthy stem cells that will, hopefully, increase the organ's ability to contract and pump more blood throughout the body. Nicely says TCA is currently accepting candidates for the cardiac protocols (the Phase I leg ischemia testing is complete) and that many of these applicants have severe physical limitations trouble breathing, active pain and often bed-ridden and are without any other alternatives.
"So you can see why they're calling us," Nicely says as the lines light up on the phone in her office.
It will still be a few years or more before the FDA approves any adult stem cell therapies. Even though TCA's leg ischemia patients have seen dramatic results, Nicely says that the purpose of Phase I protocols is only to test the safety of the stem cell infusion. Phases II and III will look at safety and efficacy. In Wert's case, he doesn't seem to care if his part in this furthering of medical science was only to make sure the procedure wasn't harmful. He sees the positive results every time he gets up and walks out the door.