How long must
the treatment continue?
In general, patients should expect
to spend from two to five years on the road to recovery.
Several factors
determine the length of time that the treatment must continue for maximal
recovery to occur. The most important is the level of injury. Higher
levels will typically take more time than lower levels. Also important
is the amount of spinal cord soft tissue that remains across the injury
site. The greater the percentage of tissue that remains, the shorter
the period of recovery we should expect. This soft tissue provides a
lattice of fibers around which the new neural fibers will construct
a live cell matrix, which will carry the necessary stimuli for sensory
and motor function.
The commitment and will of the patient
to continue the hard work of post-surgical physical therapy is also
a determining factor. The most successful patients are the most persistent.
Length of time
between injury and treatment: What effect does this have?
Although it is considered better
to initiate the treatment sooner rather than later, we find instances
in which the length of time seems not to matter. However, over time,
the mind-body connection appears to lose its memory of muscular movement.
Even when the neural connections are in place, there will still be the
need for muscular retraining, which accounts for much of the time required
for recovery.
In summary, the length of time between
the injury and the treatment does not necessarily impact negatively.
If given a choice, however, it is better to begin the procedure as soon
as feasible. In cases in which metal supports have been implanted, it
is usually wise to wait a year to allow fusion to take place prior to
surgery.
Will my insurance
cover the procedure?
Some insurance companies may
pay for the surgery, but will probably not cover the embryonic cell
transplants. You would need to speak with your own carrier on this matter.
The question
of guarantee.
The answer to this question is
more complex than simple. Each person with a spinal cord injury is different
from all others. They occur at different levels, some higher or lower
along the spine, or with multiple injury sites. Transplanted neural
cells tend to grow at a rate of 1 cm / week. Patients with a level C-3
injury, for example, will advance toward full recovery more slowly than
will a patient with a T-6 injury. In addition, the damage to the cord
itself will vary. In some cases, the cord is cut completely. This is
the patient we cannot assist. Some cords, although not transected, will
be more severely damaged than others, with less neural mass across the
injury site. Those with more neural mass at the injury site will typically
progress more quickly than those with less. In other cases there may
be cysts that are pressing against the cord, or scarring tissue that
is constricting the cord and constraining the neural impulses that must
be present for sensation and mobility. Metal objects such as bullets,
plates or Harrington rods may be present, which contribute to the uncertainty
for a specific outcome.
In addition, patients with spinal cord
injuries will differ as to their commitment to recovery or the strength
of their will for doing the very hard work, such as physical therapy,
that is an integral part of any recovery program.
It is because of these complex reasons
that a guarantee for a particular degree of recovery cannot be given,
or a precise time prediction made.
What can be said is this: The physicians
are very conservative as to who they admit into the program. They follow
strict traditional surgical protocols, and they will not perform any
surgery in which there is a risk that the patient will be made worse
by the procedure. They have progressed very slowly to be certain that
these new ideas and techniques are actually valid, and that patients,
when they follow the suggested procedures, will gain in ways not previously
known to our medical science.
It is also a fact that our patients are
making progress, although at different rates due to the variables listed
above. None of our patients have regressed or experienced biological
rejection of the embryonic cells. Most have experienced some degree
of recovery immediately following the surgery, with steady progression
as a result of the new neural growth that occurs across the injury site
due to the introduction of live embryonic cells.
The question about the FDA is appropriate,
and is not difficult to understand. In part, it is rooted in the history
of the medical profession. For most of its duration, the world of
traditional medicine has believed that once a major injury to the
spinal cord had occurred there was no hope for recovery. Although
this is beginning to change, deep skepticism still abounds, especially
in those quarters responsible for giving the stamp of approval to
a procedure that purports to genuinely assist in this process.
The typical approach to overcoming
these barriers in the United States is the avenue of animal research,
which takes substantial funding and facilities and time. It takes
years of preliminary research, first on animals and then humans, and
then additional funds to present the case to the FDA. The ****** Project
(name deleted), for example, is well known for its research models
with animals and is well funded, but when presented with a patient
of ours who had demonstrated new levels of functional ability, denied
that it had occurred, even though the patient was originally diagnosed
at that facility as being "complete" and the progress is documented
by both EMG results and by a renewed lifestyle. It would seem that
some medical and research personnel there, as elsewhere, may be assuming
that genuine progress is actually not possible. One might ask, then,
why such facilities continue to request additional grant moneys. It
is an interesting paradox to observe.
In the meantime, there continue to
be individuals who are injured. They continue to need some form of
valid assistance. The clinic actually began its work under pressure
from its first patient, Israel. He knew of Dr. Kuhnau's research with
live embryonic cell implants. He knew Dr. Ramirez's reputation as
an orthopedic surgeon. He came to them and begged them to do a procedure,
for he had nothing to lose. He was effectively quadriplegic, and wanted
desperately to return to his career as a deep water diver.
Dr. Ramirez finally agreed. He obtained
the services of Dr. Romero, a neurosurgeon who had much experience
with decompression surgery, but who had become disenchanted with its
results when done as the only intervention. The rest is history. Israel
is now walking, with occasional assistance, and has returned to diving.
He continues to make further progress.
There is also a rather jaded and parochial
outlook in the US on procedures that have been developed in Europe.
The procedures used by the clinic are actually a combination of several
approaches. First, decompression at the injury site. Second, microsurgery
to remove scarring tissue. Third, a procedure developed by our neurosurgeon
to drain cysts continuously in order to prevent them from developing
again, which they will. Fourth, the xenotransplant therapy developed
in Germany by Dr. Kuhnau, now residing in Mexico. Fifth, a strong
adherence to rehabilitative medicine in the form of both EMG analysis
of functional changes and physical therapy procedures to strengthen
muscles and retrain neuromuscular pathways. Finally, there is the
belief that both psychosocial support and the creative use of the
mind for healing are important adjuncts.
These procedures, each of which has
its adherents and which have their own forms of validation, have not
been used previously in tandem. General acceptance faces an uphill
battle. In the meantime, patients are being helped.
Although to the uninitiated the procedure
sounds too far out on the cutting edge to be evaluated or trusted
by traditional medicine, you will discover that in fact the physicians
are very conservative and adhere strictly to traditional surgical
and rehabilitative protocols, while at the same time are observing
the benefits of these additional measures and therefore are willing
to proceed even in the face of detractors who have not evaluated their
outcomes.
In fairness, however, to those who
distrust, there have been too many examples of those who have used
the personal tragedies of the spinal cord injured for personal and
unethical gain. It is difficult sometimes to decipher the valid program
from the ones that have done irreparable damage to the profession
at large.
We would
be concerned if someone approached this important decision without
a degree of healthy caution. Answering your probing and insightful
questions is an important part of our work. We have found that those
who explore most deeply before committing to the treatment are the
most successful patients.
Is there someone
with whom I can speak in Spanish?
Yes. Dr. Ramirez, the medical
director, speaks fluent Spanish as well as English. If you are more
comfortable speaking Spanish, he will be pleased to discuss the procedure
with you.
Can I visit your
facility?
Yes. We encourage you to do so.
You might want to make your visit coincide with your medical evaluation,
but this is not required. We ask only that you make an appointment to
be certain that the medical staff, and preferably some of our patients,
are available to speak with you. You can contact us by e-mail or phone
to make the arrangements.
What are the
disqualifiers for the program?
The typical disqualifiers for
treatment fall into three categories: Medical, Immigration and Naturalization
status, and Financial.
The program cannot currently treat patients
whose spinal cord has been severed completely. This is not the same,
however, as a diagnosis known as "complete," which refers to the measured
absence of sensory and motor function below the injury site, typically
made at the time of the injury by the original treating facility. Most
of our patients have been previously diagnosed as complete, but are
nonetheless making substantial progress in terms of measurable increases
in function.
A patient will be disqualified if there
is a risk, as determined by both the orthopedic surgeon and the neurosurgeon,
that a patient may lose function as a result of the surgery. This includes,
for example, a bullet fragment that may shift position during surgery
and transect the cord or move higher, thereby reducing function through
additional compression against the cord. Infectious diseases, if present,
are in need of treatment before surgery can be approved.
A patient may also be disqualified if they
are currently using non-prescribed (illegal) drugs for recreation or
pain relief. If this drug use is recent but not current, a frank discussion
with the medical evaluation team is necessary. The reason for this caution
is medical rather than legal. Patients who use certain types of non-prescribed
drugs place themselves at risk during the surgery, and undermine the
biomedical effectiveness of the post-surgical embryonic cell therapy
program.
The treatment program is sophisticated,
complex and time consuming, requiring a high level of technical and
medical proficiency, and professional commitment to the patient. There
are also substantial direct costs associated with the program that cannot
be avoided. Unfortunately it is for these reasons that the program must
require that a patient be able to sustain the financial costs of treatment.
Finally, a patient whose country of citizenship
is not currently in the US or Mexico will need a valid US or Mexican
VISA. The patient unable to obtain a current visitors VISA to either
country will be disqualified by virtue of the fact that they will not
be able to travel freely between the US and Mexico. Patients with a
valid Mexican VISA could choose to stay in Mexico for the duration of
the treatment, with occasional travel to the United States.
If you are unsure of your current status,
we can discuss your case with an attorney specializing in immigration
law or refer you directly for an appointment.
Does everyone
need to have surgery?
No. There are instances in which the anatomical status of the spinal
cord or spinal column does not require surgical correction. In these
cases, it is possible to proceed directly to the embryonic cell treatment.
How soon will
I start recovering?
Usually immediately. Patients typically report, confirmed by EMG measurements,
several centimeters of new function below the injury site shortly after
surgery. This is often due to decompression of the spinal cord at the
injury site. Patients who follow the recommended medical regimen for
embryonic cell implants, coupled with frequent rehabilitation therapy,
will then typically observe one centimeter of new function per week.
It should be noted, however, that the neural
growth of 1 cm per week does not automatically translate into new movement.
There is a latency period during which the brain-body connection must
undergo retraining and strengthening. This is what is referred to as
the "hard work" of recovery.
How long is the
post-surgical recovery period?
Immediately following surgery,
complete bed rest is required for a period of two to three days. Most
patients are feeling strong by this point and wish to return to their
wheel chair, which is permitted. It is typical for patients to feel
strong enough to travel by the fifth day, but this will depend upon
individual differences. Normally, patients report minimal pain following
surgery.
Following each embryonic cell implant procedure,
patients are requested to refrain from strenuous exercise, such as rehabilitation
therapy, and to avoid strong sunlight for a period of 48 hours.
Can I receive
follow-up treatment in my home state or country of residence?
There are patients who are receiving the embryonic cell treatment in
their state or country of origin. This does require a physician willing
to cooperate with the procedure and who has the technical skills necessary
for administration of the biomedical materials.
In this instance, the biomedical materials
must be transported in a frozen state by a carrier experienced in transporting
biomedicals.
Patients who choose this option are required
to return to the clinic for periodic evaluation.
Other patients have chosen to relocate
closer to the clinic, either temporarily or permanently, so as to take
advantage of the rehabilitative and consultative capabilities of the
clinic staff.
What is the current
status of FDA approval for the treatment?
The FDA has not approved the
embryonic cell treatment, nor has it actively rejected it. The complex
approval process is beyond the capabilities of ISCRC resources to actively
pursue at this time.
Nevertheless, the basic premises of the
surgical procedures, such as decompression, orthopedic reconstruction,
microsurgical removal of scarring tissue and the shunting of cyst fluids,
falls well within FDA guidelines. (Please also refer to the question
"Why in Mexico?" above).
Are research
laboratories studying embryonic cell therapy?
Live embryonic cell implants
are gaining wider attention in the research laboratory, with supporting
evidence being offered almost daily. A recent meeting of The 6th
International Neural Transplant Meeting, (February 13-16, 1997,
Hotel del Coronado, San Diego, California) co-sponsored by the American
Paralysis Association and the American Society for Neural Transplantation,
among others, and chaired by Fred H. Gage of the Salk Institute, provided
exciting evidence that supports the idea that live embryonic cell transplants
are indeed a viable option for spinal cord injuries. This research supports
the contention that new neural growth does occur, and that sensory and
motor function can be recovered. Other research has focused on different
delivery systems, such as embryonic cells encapsulated in special gels.
In Brazil, surgeons have demonstrated that a patient’s own nerves
can be successfully transplanted to the injury site.
Dr. Carlos Romero Gaitán, ISCRC chief neurosurgeon
and professor of neurology at the University of Baja California, has
presented papers to the Mexican Medical Congress on the topic.
Although progressing slowly, the procedures
being developed by the ISCRC are gaining the attention of animal researchers
specializing in embryonic cell implantation and recovery from serious
spinal cord injuries. The ISCRC has been ahead of its time by courageously
applying knowledge known for decades in other countries to the successful
rehabilitation of human injury.
Does Christopher
Reeve know about this treatment?
Not to our knowledge. We believe
it is unethical to approach any individual directly without a formal
request for information.
How can I get additional
information on what you do?
You can contact us by telephone,
e-mail, fax or US postal. We encourage you to do so. We will be happy
to send you additional information, and answer your questions in person.
In addition, you can order a video tape
of the procedure, which includes interviews with medical staff and patients.
A monograph by Dr. Wolfram Kuhnau, who studied embryonic cell transplantation
for decades in Germany, is also available for purchase. Ordering information
can be obtained by referring back to our home page.
Conclusion
We do hope that these answers
will assist you determine whether this procedure is something that you
want to pursue further.
Please feel free to contact us
if you have additional questions.