Tuesday, July 16, 2013

Dr. Dipnarine Maharaj MD Interview with Turkish Newspaper (2011)

Interview Questions


Dr Maharaj


Q: Please state and spell your name.



Q: Please provide the name of your clinic.


The South Florida Bone Marrow Stem Cell Transplant Institute.


Q: Could you tell us about your medical training and background?


Dipnarine Maharaj, MB.ChB. , MD, FRCP(Glasg.), FRCP (Edin.), FRCPath. FACP.


Dr. Dipnarine Maharaj is the Medical Director and founder of the South Florida Bone Marrow/Stem Cell Transplant Institute, one of the few completely outpatient bone marrow/stem cell transplant facilities in the country.  He was also involved in the establishment of bone marrow/ stem cell transplant programs at the University of Miami and for other communities in Florida. He has been involved with clinical research studies using stem cells in the areas of cardiac regeneration, neurodegenerative diseases, and cancer treatments.  Most recently, he has secured an Investigator-initiated IND from the FDA to study a novel treatment of solid tumors using only healthy white blood cells.   His innovative approach to medicine has earned him international recognition.


Dr. Maharaj earned both his medical degree and research doctorate at the University of Glasgow Medical School. He is also certified in Internal Medicine by the Royal College of Physicians of the UK, and has accreditations in Hematology, specializing in oncology and bone marrow transplantation.  He has been a lecturer on Internal medicine, hematology, and bone marrow transplantation at medical schools and universities in the US and Europe, and is currently Professor at the Charles E. Schmidt College of Biomedical Science of Florida Atlantic University.  Dr. Maharaj maintains professional memberships in the American Medical Association, American Society of Clinical Oncology, American Society of Hematology, International Bone Marrow Transplant Registry, American Society of Blood and Bone Marrow Transplantation, and the American Society of Internal Medicine.


Q:  We understand that the US Food and Drug Administration granted you an Investigational New Drug (IND) to perform a clinical trial regarding a new cancer therapy.  Could you provide us with details of your cancer treatment?

The South Florida Bone Marrow/Stem Cell Transplant Institute is now running a new clinical trial protocol (08001-BMSCTI) for investigating a novel cancer therapy using transfusions of white blood cells from healthy donors. This investigative new cancer therapy was developed from the exciting research results of studying natural cancer resistance in a unique strain of lab mouse (SR/CR mice) and in some healthy humans.

This newly discovered innate activity for cancer resistance is mediated entirely by specific populations of leukocytes (specifically granulocytes and monocytes) that can be transfused from one individual to another for highly effective treatment of advanced cancers. We hope that the results from this clinical trial and other on-going research efforts 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.

There are over 100 million cancer patients in the world - 10 million of them in the US alone. Each day, over 16,000 of these people die because there is no effective treatment for them, or because they no longer respond to conventional cancer therapies. For such people, a new kind of therapy is their only hope for survival.

Clinical trial 08001-BMSCTI will study an investigational new cancer treatment. It will study the ability to transfer naturally occurring cancer-killing activity (CKA) in the granulocytes of selected donors into the body of a cancer patient.

Healthy young volunteers will be screened for the level of CKA, blood types, HLA types, infectious disease status, CMV status etc. by blood tests and physical examinations. The selected volunteers will become part of the Donor Registry. The test results of selected volunteers will be used to match with specific patients.

When a qualified patient is identified for treatment, granulocytes from several matched donors in the Donor Registry will be mobilized by two medications and collected by a well-established medical procedure called "apheresis" or "pheresis." A pheresis machine separates donor granulocytes from other blood products that will be immediately returned to donors so that the health impact on granulocyte donation is much smaller than on whole blood donation. Granulocyte mobilization and collection by apheresis have been used in clinical practices for a long time with very good safety record.

Qualified patients will be selected according to general health condition, disease status and match criteria. Freshly collected granulocytes from matched donors will be given to patients via IV infusion. Granulocytes cannot be stored or shipped for later uses.

Q:  Tell us about what is necessary to successfully complete Phase I-II of the trial


There are three elements.  1.  Primary need is funding.  2.  Recruitment of young healthy donors to provide the cells of their normal immune system, which is resistant to cancer.  3.  Patients with different types of cancers who satisfy the eligibility criteria of the treatment protocol.


Q:  Can you tell us about your success rate of treatment thus far?


To date we have treated five patients.  The protocol requires an interim analysis after the treatment of 20 patients.  To give information at this time would be premature and could be misleading.


Q:  Can you distinguish between stem cells produced in bone marrow and stem cells produced in one’s blood.


Stem cells are produced in an individual’s own bone marrow.  The different types of cells are endothelial stem cells, hemopoietic stem cells, and mesenchymal stem cells.  These cells are released into the blood on a daily basis and the numbers can be increased by different stimuli, for example:  inflammation, and different drugs.


Q:  Please describe the different methods of harvesting such stem cells.


The stem cells can be physically extracted from the bone marrow or medications can be given to the patient, which releases the stem cells into the blood from which they are harvested using an apheresis machine.


Q:  Can you describe the perfect donor of stem cells?


A young healthy individual.


Q:  We understand that you are currently negotiating with several prominent medical groups regarding making your treatment available in Turkey and some other Southeastern Europe countries.  What can you tell us about this?


We are very excited about the opportunity of taking our program and treatments and making it available to more patients in Turkey and Southeastern European countries.  We have an innovative, totally out-patient bone marrow stem cell transplant program which is the only one of its kind in the State of Florida and possibly in the United States.  We have treatment protocols for blood cancers where we have been able to successfully produce long-term disease free survival in these patients.  We are also developing treatments for chronic diseases such as cardiac, neurological and metabolic disorders such as diabetes.  In addition, we perform cord blood banking as well as an adult healthy stem cell collection and storage program.  


We are currently in discussions with several prominent medical groups that are dedicated to making our treatment available to residents of this region.  We are excited about making our treatment available to Turkey and other neighboring countries, and we are hopeful to conclude some sort of agreement in the foreseeable future.


Q:  Where can Turkish patients receive such treatments?


A:  Currently Turkish patients would need to come to South Florida to receive treatments on an out patient basis.  The duration of the patient’s stay will depend on their diagnosis and conditions.


Q:  Do you see a time when this technology will be available in Turkey?


A:  We are hopeful that once we have completed our clinical trials to partner with different groups to make this treatment available on a worldwide basis.


Q:  Do you believe that you can cure cancer?


I have been treating patients with different kinds of blood cancers since 1984.  We have shown long-term survival in many of these patients using stem cell transplants either from the patient’s own bone marrow or a donor.  We are currently investigating whether we can translate the curative cancer treatment developed in mice into humans.  This is based on the transfer of a cancer resistant immune system from young healthy donors into individuals with different types of solid cancers.

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