The
therapies previously discussed in this series on alternative medicine
for spinal cord injury (SCI) generally have few side effects, are
minimally invasive, and are relatively inexpensive. Hence, there is
little to lose and potentially much to gain.
However, this is
not the case with the International Spinal Cord Regeneration Center (ISCRC),
located in Tijuana, Mexico. The Center represents an intensive, costly
program, involving inherently risky spinal surgery and a controversial,
shark embryo cell transplantation procedure.
Nevertheless, in spite of
being ignored by the established SCI health-care and research community,
treated individuals believe that they have benefited considerably.
Program
Description:
Staff
Regardless of the
Center’s “alternative” status, ISCRC staff consists of
conventionally trained health professionals. For example, founder and
director, Dr Fernando Ramirez, received training at leading medical
schools in the U.S. and England. He
demonstrates considerable knowledge of not only state-of-the-art,
mainstream science but also of alternative approaches not well
appreciated in the U.S.
By
working in Mexico, a country with a more relaxed health-care philosophy,
he feels that he has much more latitude in attempting to integrate
innovative and established treatments that can help people with spinal
cord injury.
Surgery
The program
generally targets individuals who have sustained a compression injury in
which their cords have been crushed but not completely severed. Although
such injuries are often diagnosed as clinically complete (i.e., no
sensation or movement below the injury site), frequently some neurons
remain structurally intact across the injury site.
Initially, the
spinal cord is repaired during a lengthy decompression and
reconstructive surgical procedure. Doctors remove bone fragments and
scarring tissue from the injury site.
In addition, any cysts that may have developed following injury
are drained, and a shunt is inserted to keep fluid from accumulating.
The spinal column is then reconstructed and strengthened. In the
next step, embryonic neuronal cells obtained from the blue shark are
inserted into the spinal cord at the injury site.
Center staff claim that these cells will eventually form an
infrastructure matrix that will facilitate neural transmissions, and, in
turn, restore some function.
Follow-up
Treatment
Although some recovery is anticipated soon after
surgery, significant improvement requires embryonic shark-cell
injections every two weeks for several years. In these follow-up
treatments, the cells are injected into muscle groups along the midline
on both sides of the spine at levels corresponding with demonstrated
sensation.
Although mainstream scientists are skeptical, these
site-specific embryonic neuronal cells will reportedly migrate to the
patient’s spinal cord even if they are injected into the muscle. Over
time, as sensory awareness improves, doctors give these injections at
increasingly lower dermatome levels (areas on the body that matches a
specific spinal cord level). In
addition to the embryonic cells, nerve growth factors and scarring
inhibitors are also injected to facilitate regeneration. Patients
initiate rigorous physical rehabilitation programs to strengthen
supporting muscles and to retrain neural pathways.
Patient
Outcomes
Since
the program started in the early 1990’s, the Center has treated over
30 people with spinal cord injury. Most patients who have persisted with
the program reportedly have had some functional improvement. The most
dramatic has been the earlier treated individuals who have had the most
follow-up treatments. For example, the center’s first patient Israel
underwent surgery in 1990 two years after an injury due to a diving
accident. After years of follow-up therapy, he is now walking with the
occasional use of leg braces, and he continues to improve. In addition
to overall increased sensory and motor function, a number of the early
treated patients report regained bowel and bladder control.
In
response to criticism that it over relied on the subjective impressions
of doctors and patients to measure improvement, the program is now using
a procedure called dermatomal somatosensory evoked potential. With
this procedure, a low-voltage potential is passed between scalp
electrodes and electrodes placed on the skin at locations on the body
representing functional levels. Because the electrical signal is
transmitted through the spinal cord, signal transmission is interrupted
if sufficient, functional neurons do not exist.
Hence,
by evaluating this signal before and periodically after treatment,
doctors can measure improvement independent of subjective bias. An
independent neurologist board certified and licensed by the State of
California carries out this assessment. Although the procedure addresses
a major criticism, it is expensive, emphasizing the tradeoff that often
exists between the need for scientific rigor and cost containment.
Cost: As
expected from the program’s intensity, the cost is substantial.
Depending on patient’s unique needs, the initial procedure itself
ranges from $30,000 - $45,000, and follow-up treatments are estimated at
over $20,000 per year. As an experimental therapy, insurance coverage is
questionable.
Embryonic
Cell Transplantation - The Controversy:
History
The
most controversial aspect of the program is its embryo cell transfer
procedure. Live cell therapy, involving the transfer of embryonic cells
from other species into humans, has an intriguing history. Based on
procedures developed by Swiss physician Dr. Paul Niehans in the
1930’s, it has been used to treat a wide range of disorders. Although
live cell therapy has considerable acceptance in Europe (as well as some
controversy), it has not been allowed in the U.S.
Over the years, the therapy acquired a reputation and was used by
many famous individuals, including Pope Pious XII, Charlie Chaplan,
Dwight Eisenhower, and Winston Churchill. Today, the procedure is
carried out in exclusive Swiss clinics that cater to the rich.
Dr.
Wolfram Kuhnau, a protégé of Dr. Niehans, developed the use of blue
shark embryo cells and now provides them to the Center. A 90-year old
German physician who currently lives in Mexico, Dr. Kuhnau has a long
history of scientific achievements dating back to the 1930’s,
including collaborations with a Nobel laureate. His rationale for using
blue shark embryo cells was based on the shark’s uniquely strong
immune system, which, it is claimed, enhances transplantation efficacy.
Interestingly, the actual procedure to treat spinal cord injury
was initiated by the first patient Israel, mentioned above.
Specifically, after hearing about Dr. Kuhnau’s work in treating other
neurological disorders, Israel convinced Dr. Kuhnau to treat him and
then facilitated the collaboration with Dr. Ramirez to obtain the
surgical expertise.
Embryonic
Cell Transplantation
Embryonic
cells clearly are unique. Due
to their early developmental stage, they are extremely adaptable and, as
a result, less likely to be rejected by the host. Although remaining
controversial, Dr. Ramirez feels that their program has been
increasingly vindicated conceptually by evolving mainstream science.
Although they would refuse to acknowledge it, he believes that the
scientific community in many respects is catching up to what their
clinic has already done. Until recently, the prevailing dogma was that
cellular implantation into injured spinal cord would not work. Now,
however, scientists believe it is a promising research area with great
potential for restoring function.
For
example, mainstream neuroscientists have recently started transplanting human
embryo cells into the expanding syringomyelia cysts of individuals
with spinal cord injury. The transplanted cells grow and obliterate the
cyst, restoring function lost due to cyst expansion.
Many scientists believe the same approach will eventually be used
to restore function lost to SCI, which, Dr. Ramirez notes is essentially
the clinic’s emphasis. In another example, Dr. Ramirez feels that
recent state-of-the-art research involving neuronal stem cells supports
the clinic’s approach. Basically, these stem cells represent
omni-potential master cells that have the ability to differentiate into
a variety of specific cell types, including function-restoring neurons.
Blue shark embryonic cells should be a rich source of such stem cells.
Although
the transplantation of embryonic cells is gaining increased acceptance,
critics remain concerned about transferring cells representing a vastly
divergent species into the human spinal cord. Given potential (albeit to
date unrealized) long-term risks associated with such cross-species
transplantation, critics believe that the Center has not provided a
compelling rationale to justify the use of blue shark embryo cells. Dr.
Ramirez responds that embryonic cross-species transplantation has had a
history of successful, safe use in Europe that is not well appreciated
by U.S. practitioners.
Although
procedures sound theoretically plausible, critics feel it is difficult
to evaluate the program because specifics and details are lacking.
Furthermore, scientists are uncomfortable with multi-faceted treatment
programs such as this one because it is difficult to identify specific
cause and effect. Improvement could be due to any one or combination of
factors. In addition, as is often the situation with many alternative
programs that operate outside the scientific, academic community, the
Center has not shared its results in professional journals where they
can be scrutinized. Such a process would facilitate mainstream
acceptance. Although acknowledging this deficiency, Dr. Ramirez feels
his focus on patients instead of science is not inappropriate. He
further notes that few scientists have accepted his ongoing invitation
to visit the clinic and become more familiar with its procedures.
Conclusion
In
summary, this clinic represents an intriguing alternative therapy for
individuals with SCI. Although the “experts” tend to dismiss the
program, individuals who have persevered believe in its benefits. By
ignoring the conventional wisdom of science and its widely perceived
glacial pace for creating real-world solutions for spinal cord injury,
did Dr. Ramirez and his colleagues decide to, like in the well-known
Nike commercial, “just do
it”? Or have they taken advantage of a vulnerable population based on
pseudoscientific claims and theories. Clearly, given the nature of the
intervention and its cost, readers should be cautious if considering the
program and carefully weigh pros and cons.
For further
information on the International Spinal Cord Regeneration Center, call
619/463-5350 or see the web site www.electriciti.com/spinal/.
The Center has made available a list of treated patients that can
be contacted.
Adapted
from an article appearing in the September & October 1999 issues of Paraplegia
News (For subscriptions, contact www.pn-magazine.com).
