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.
