Life Extension is Funding Study of Therapy That Cured Cancer in 100% of Mice

Home Recovery

Innovative treatment naturally calls for a novel approach to patient care. According to Dr. Maharaj, the Institute’s idea is to treat cancer patients in an environment which gives a good quality of life: specifically, an outpatient setting. “In fact, we are the only free-standing totally outpatient stem cell cancer treatment center in Florida,” he states.

Dr. Maharaj points to studies that prove the validity of this approach: in a 2004 study published in the Critical Care Journal,23 for example, 600,000 patients in six states across the US were examined. Incidence of infections in cancer patients were broken up according to disease type. Patients with acute leukemia were 66 times more likely to get an infection (sepsis) in a hospital than a patient coming in with a heart attack. Similar statistics were seen with multiple myeloma (40 times greater risk), and lymphoma (16-20 times greater). Almost 5% of the cancer patients that were hospitalized in the six states were found to have severe sepsis, translating to around 126,000 on average cases nationwide. The data also showed that hospitalized patients with cancer and severe sepsis were more than five times as likely to die than cancer patients not suffering from severe sepsis.

“Patients with hematological malignancies by their nature have a very high risk of infection because it’s a disease of the immune system,” Dr. Maharaj explains. “Intermediate or high-dose chemotherapy patients have an additional layer of risk due to the severe immunosuppressive effects of the chemotherapy. Some of these infections cannot be treated with even the highest-level potency of antibiotics that we have available. And these types of infections are prevalent in hospitals.”

“When I came from Scotland to Florida, I was recruited to assist in the development of the bone marrow program at the University of Miami,” Dr. Maharaj recalls. “What I saw in inpatient programs were major problems with complications directly traceable to infections. I thought that using the same approach to treatment while preventing the complications would be a much more proactive way of doing things.”

At the Institute, infections are controlled by strict attention to hand washing, as well as prophylactic use of antibiotics. “In an inpatient setting, if you give a patient ten times the dose of standard chemotherapy, that means ten times the risk of infection in a hospital. By allowing a patient to recover from treatment at home, we can largely avoid that risk.” Close scrutiny and evaluations also allow early intervention and treatment in the case of post-chemotherapy toxicities, further helping prevent in-patient hospitalizations. “We monitor 47 potential toxicities a day,” he says. “For each of those, we want to see no evidence of bad reactions.”

Another accomplishment at the Institute is the ability to administer high doses of chemotherapy while largely mitigating typical side effects like nausea, vomiting and diarrhea, or mucositis (ulceration in the digestive tract and/or mouth). “To permit treatment in the outpatient setting, we obviously need to avoid these side effects or keep them to an absolute minimum,” says Dr. Maharaj. “Thus we’ll give anti-nausea medications and other drugs in advance, rather than waiting for the problem to occur.”

Spreading the Word

By contrast, Dr. Maharaj says typical inpatient hospital transplant care is reactive; i.e., treatment of complications happens as and when they arise, which only results in prolonged hospitalization. “Reducing or eliminating hospital admissions results in significant cost savings to patients, insurance companies and employers.” At-home recovery also allows patients to return to work or to resume normal daily activities sooner. But even more importantly, adds Dr. Maharaj, patients who receive a totally outpatient bone marrow/stem cell transplant return home following treatments and remain with their loved ones. “As many of our patients have testified, this can be especially helpful from the point of view of mental well-being, because people don’t feel as sick when they are at home compared to when they’re in a hospital.”

The stem cell transplant protocols employed by Dr. Maharaj and his South Florida Institute colleagues are medically accepted and widely utilized in many other transplant centers in the country, as is administration of high-dose chemotherapy. What is not standard, he says, is the outpatient approach to treatment. “It is difficult to understand why this isn’t more widespread,” says Dr. Maharaj. “We are successfully tackling some of the major risk factors found in hospitals, so I am at a loss to explain why there are not more centers that are treating patients with this more preventive approach.”

Indeed, some oncologists argue that the outpatient approach is risky for the patient. “I counter that by pointing to the fact that I have been giving high-dose chemotherapy in an outpatient setting since 1995,24 and we have a 0% procedural mortality rate as well as a demonstrated ability to prevent infections and other complications. Our patients have done very well, and in our hands the outpatient model has proven to be safe and effective.”24 Patient satisfaction is also high: “They love that they can receive their treatment in eight hours, instead of 24 in a typical hospital setting, and then they’re able to go home to be with their families, or back to a hotel in the case of patients visiting from outside the area.”

Dr. Maharaj stresses again that such a positive mental approach is crucial for healing. “When patients know they are going home instead of staying in a hospital, the obvious positive psychological effect improves their outcome.”

Helping Hand

The South Florida Institute is currently taking stem cell transplant research to an even higher level with a series of clinical trials designed to test the rebuilding of a cancer patient’s damaged immune system using the healthy immune systems of young individuals. “It’s a novel cancer therapy using transfusions of white blood cells from these healthy donors,” says Dr. Maharaj, adding that this newly-discovered innate activity for cancer resistance is made possible by specific populations of leukocytes (granulocytes and monocytes) that can be transfused from one individual to another.

Dr. Maharaj says he and his research team were approached by Life Extension Foundation board co-founders William Faloon and Saul Kent, who expressed interest in providing a grant to assist the Institute in getting the clinical trial up and running. “After we had received the necessary federal approvals to start the trial, we had no funding,” he says. “It was clear to me that Life Extension’s founders had been studying the background of this trial and were very well informed. After we met, I could see their commitment to wanting to help patients with cancer. They understand that the majority of treatments we have right now are simply not very effective, and this represents a possible path to a new approach in treatment.”

Dr. Maharaj says the Life Extension grant allowed the South Florida Institute to start screening healthy young volunteers for the trial. While it is obviously too early to chart results, he hopes that these clinical trials will one day lead to an effective, nontoxic treatment that can provide clear clinical benefit to cancer patients who can no longer benefit from conventional treatments. The Institute is also planning to participate in other clinical studies utilizing stem cells in the arena of regenerative medicine for cardiac repair, neurological repair, and also for diabetic patients.

It is a dynamic field of study for Dr. Maharaj, who urges individuals to have some of their own stem cells collected and stored when they are young and healthy, both from a future therapeutic point of view and being able to take advantage of the developments in genetics. “Ultimately, we may be able to predict cancer and other future diseases from your own stem cells,” he says. For Dr. Maharaj, all of this fits in neatly with Life Extension’s model. “To me, the term life extension means prolonging an individual’s life with good quality of life,” he concludes. “And that is precisely what we are trying to do.”

For more information, visit the website of the South Florida Bone Marrow Stem Cell Transplant Institute at www.bmscti.org.