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

In a discovery that made headline news around the world, Dr. Zheng Cui of the Wake Forest University School of Medicine developed a colony of mice with super-charged granulocytes that successfully fight off any form of virulent transplanted cancer.1 These super-charged granulocytes infiltrate tumor cells and destroy them. The mice given these potent granulocytes are healthy, cancer free, and have a normal life span.

This research project started serendipitously in 1999 when Dr. Cui was testing the effects of administering cancer cells to mice. He found that one mouse did not develop tumors no matter how many cancer cells he administered. Further investigation led Dr. Cui to discover that the mouse that appeared to be immune from cancer had an extra amount of potent granulocytes for specifically killing cancer cells without harming normal cells. When Dr. Cui administered these potent granulocytes to mice with cancer, he cured them.2

This discovery was heavily publicized in 2007-2008, yet no one stepped forward to fund a clinical study to see if this immune-augmentation therapy could cure cancer in humans. When the Life Extension Foundation® learned that this potential breakthrough was not being funded, we immediately made a $200,000 grant to help fund a human clinical trial at the South Florida Bone Marrow/Stem Cell Transplant Institute located in Boynton Beach, Florida.

The rationales behind this human study are laboratory experiments showing that some people’s immune cells can be almost 50 times more effective in fighting cancer than others.3 It is now possible to harvest these super-charged granulocytes from healthy young donors and infuse them into cancer patients with curative intent.

This clinical trial will test this approach in humans with advanced cancer, including metastases, who have not been helped by conventional cancer therapies. The trial has received an IND (investigational new drug) status from the FDA and Institutional Review Board approval. The principal investigator/lead physician for this trial is Dipnarine Maharaj, MD, who has in-depth experience in stem cell transplantation, including transfusion of blood products, hematology, and oncology.

In January of this year, Dr. Maharaj notified the Life Extension Foundation that progress was being slowed because expected funding sources had dried up. Life Extension responded with additional funding commitments to facilitate this critical research.

Dr. Maharaj, the Director of the South Florida Bone Marrow/Stem Cell Transplant Institute, stated, “It would have been impossible for this project to exist without funding from the Life Extension Foundation.”

According to William Faloon, who co-founded the Life Extension Foundation in 1980, “These research grants have been awarded to help find a cure for cancer… Life Extension has no financial interest in the outcome of this research… Life Extension does have an interest in being able to recommend a validated cure for cancer to its millions of supporters worldwide.”

Cancer patients who want further information about participating in this new study can contact Dr. Dipnarine Maharaj, Principal Investigator at 561-752-5522 or Dr. Steven Hirsh of the Life Extension Foundation at 954-766-8433 or log on to Dr. Maharaj’s website www.bmscti.org.

The clinical trial expenses include donor costs and building a healthy Donor Registry which is crucial as these donors are the ‘medicine’ for the cancer patients. There are tremendous costs involved in screening and testing donors, for which Life Extension has provided the main initial funding. However, the clinical trial requires an additional $5 million in order to treat the study’s quota of patients (up to 29 allowed by the protocol). Until such funding is available, patients who wish to get onto the study’s waiting list are encouraged to visit Dr. Maharaj’s website at www.bmscti.org to learn more about the study and fill out an application. Those wishing to contribute financially can also find information about donations on the website.

The following article describes the unique methods used by Dr. Maharaj to treat hematological cancers at his clinic.

The Immune System:  A New Ally in Cancer War, by Stephen Laifer

Hematologist/Oncologist Dipnarine Maharaj, MD, medical director of the South Florida Bone Marrow Stem Cell Transplant Institute, utilizes bone marrow stem cell transplants to combat several common forms of cancer.4-8 One aspect that makes his approach unique is that the body’s own immune system is conscripted into the fight. “Bone marrow stem cell transplant is a procedure whereby we treat patients suffering from different types of blood cancers,” explains Dr. Maharaj. “The essence of the treatment is to repair the body’s immune system using its own healthy stem cells.”

Dr. Maharaj has been involved in bone marrow stem cell research and its possible applications since 1984.4 His roots as an innovator go back to childhood: his father and brothers were engineers. His mother and sisters, on the other hand, were nurses. “My mother wanted me to be involved in medicine,” he recalls. “She would take me to the clinic when I was younger, and I got used to the idea that doctors do good things. But the engineering influence made me also want to be an innovator.”

Medical studies in Glasgow, Scotland led to specializations in stem cell hematology and oncology, which Dr. Maharaj chose because he saw them as an area where he could make a real difference in the quality of cancer care. In Scotland, he was also involved with one of the first groups to explore bone marrow stem cell transplants.4 Today, aside from running the South Florida Bone Marrow Stem Cell Transplant Institute, he is also a lecturer in biological sciences at Florida Atlantic University. “My education helped shape me as a doctor and as a person. But for me, learning never ends,” he says.

Clean Stem Cells

Many of Dr. Maharaj’s patients come to the Institute after being told by other doctors there is nothing more that can be done for them. The first step, he says, is to get rid of the cancer in the patient’s bone marrow. “Often this requires very high doses of chemotherapy to overcome the tumor cells’ resistance to standard doses,”4-8 he says. He favors the analogy of a hammer: “You can crack a nut with a small hammer, meaning standard chemotherapy in this case. But if the nut is resistant, you have to use a sledgehammer.”

Stem cell transplants can either be the patient’s own, after having been cleaned of cancer cells, or they can be from a donor with the correct tissue match.9-12 Dr. Maharaj says the ideal situation in many cancers is to identify a compatible donor, because stem cells are then sourced from an individual who has a normal immune system. However, in the conditions which he usually treats—multiple myelomas, non-Hodgkin’s lymphomas, Hodgkin’s disease and leukemia13-16—patients typically have a better outcome when using their own stem cells. “That’s because these particular diseases tend to be more prevalent in older patients. Infections, graft rejections and other complications tend to be more frequent in older patients when a donor is involved.”

With a patient’s own stem cells, Dr. Maharaj stresses that scouring cancer while the marrow is still in the body is a crucial first step. “Many studies demonstrate that even if you purge the stem cells of the cancer in the lab, if you haven’t first gotten the patient to the point where the tumor is basically eradicated, then the outcome isn’t as positive,”14 he says. In these studies, cancer treatment centers have typically addressed cleaning the stem cells without considering how much residual cancer is still present in the patient. Patient survival in such cases is unacceptably low. “We have found that we first need to get the tumor load to the point where it is undetectable by conventional methods.15,16 Only then will we collect some of the bone marrow and store it, destroy the residual cancer in the patient with high dose chemotherapy and put the stem cells back in.”

And here is where the uniqueness of the procedure is clearly demonstrated: Dr. Maharaj says the clean stem cells allow the immune system to undergo what he calls a clonal expansion.17-22 In effect, the system is “reset” and switched back on; any remaining cancer cells are identified and destroyed by the patient’s own recharged immune system. “We’re enabling the body’s own immunity to fight the cancer. It’s exciting,” says the oncologist, betraying a bit of the engineer’s enthusiasm for innovative solutions.

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.