Welcome to the future! Embryonic Cell Transplant Therapy is no longer a dream but a reality. Embryonic Cell Transplant Therapy was pioneered by Dr. Paul Niehans in Switzerland. Dr. Wolfram Kühnau, friend and disciple of Dr. Niehans, continued his work in Embryonic Cell Transplant Therapy. Today, Dr. Fernando Ramirez del Rio with Dr. Kühnau continue to pioneer this breakthrough procedure. Dr. Ramirez is the Medical Director of the International Spinal Cord Regeneration Center, which specializes in spinal cord regeneration. Our Chief Neurosurgeon is Dr. Carlos Romero Gaitan.

Dr. Fernando Ramirez del Rio has quietly been working miracles in Tijuana Mexico for several years. He has had success regenerating spinal cords using Embryonic Cell Transplant Therapy.

ISCRC  invites you to explore the possibilities of Embryonic Cell Transplant Therapy and the International Spinal Cord Regeneration Center. Feel free to contact them at any time for more information.

Mexico has long been a Mecca for people seeking alternatives to traditional medicine. In Mexico, ethical physicians have treatment options not currently possible in the United States. Europe has a similar philosophy. The International Spinal Cord Regeneration Center is fortunate to have Dr. Fernando C. Ramirez del Rio as the Medical Director, and as an Associate one of the greatest medical minds of the 20th Century, Dr. Wolfram W. Kuhnau.

For years people have been coming to Tijuana for cancer treatments. There is a reason for this. Physicians are using therapies developed in Europe to treat their patients. They do not practice "alternative" medicine but rather "proper" medicine, since there is no alternative to proper medicine. Proper medicine is the ethical applicaiton of safe and effective technologies to the healing arts.

The location of the Center is very convenient for the patient. Being in a foreign country we are aware of the apprehensions people have is comingfor treatment. Our center is less than 500 yards from the Internationalborder, appproximately a one minute drive if coming by car. It is so close it is within easy walking distance. We'll help you arrange lodging and transportation during your stay.

The Treatment

Reconstructive Surgery

In most cases of paralysis, the spinal column has been damaged in some fashion. Using Embryonic Cell Transplant Therapy we can regenerate the nerves in the spinal cord. However, that is only part of the procedure. We have to make sure that once we begin the regeneration process on the spinal cord that there are no other obstacles to recovery. In most cases, we must perform reconstructive surgery.

Two major problems present themselves at the site of the spinal cord injury. These include compression of the spinal canal and cysts that form at the point of injury. At the site of the injury there is usually a narrowing of the spinal canal, which impedes the electrical impulses to the lower extremities through the spinal cord. With reconstructive surgery, we open up the spinal canal, removing any bone, scarring tissue or bullet fragments. We reconstruct the canal so that it has as much room as it did before the injury.

The second problem is cysts that form at the site of the injury. A cyst can also impede the electrical impulses in the spinal cord. They attach themselves to the spinal cord making it almost impossible to remove surgically. If you drain a cyst it is generally a matter of time before it fills up again with fluid. Dr. Carlos Romero Gaitán has developed a shunt that is permanently inserted into the cyst and drains it into the abdomen. This effectively solves the problem of the cyst filling up again.

Post Surgery Treatment

At the time of the surgery the surgical team implants embryonic cells into the spinal cord, which starts the regeneration process. One treatment is not enough to regenerate the damage that has been done. We recommend the patient return to our office every two weeks for additional embryonic cell transplants. The speed of recovery depends on the level of the injury and how frequently the patient comes in for embryonic cell therapy. Someone that is a C5 has a longer period of recovery than that of a L2.

During the bi-weekly visit, the doctors will evaluate the patient to see how much progress has been made and, if necessary, adjust the mixture of the embryonic cells for therapy. The patient will be able to chart their progress in a relatively short time. We have had many patients notice immediate improvements the day after the surgery.

What The Treatment Includes

The treatment program includes the following procedures:

• Initial Consultations
• Pre-Surgery Examinations
• Electromyography Test - Pre-Operative
• Peripheral Nerve Velocity Conduction - Pre-Operative
• Reconstructive Micro Surgery on the Spinal Column
• Orthopedic Reconstructive Surgery on the Spinal Column
• Embryonic Cell Transplants During the Surgery
• Hospitalization for Approximately 7 to 10 days
• Medications while Hospitalized
• Post-Surgery Follow-up Examinations
• Embryonic Cell Transplants over the course of the treatment, administered every two weeks
• Electromyography Test - Post-Operative
• Peripheral Nerve Velocity Conduction - Post-Operative
• Psychological Consultations every two weeks at the clinic location

Postulated Modes of Action

FREQUENTLY ASKED QUESTIONS

1. How does this procedure differ from other treatments?
2. If the procedure works so well, why isn’t everyone using it?
3. Why do you use embryonic rather than fetal cells?
4. Why do you use the blue shark as the donor organism?
5. Are there side effects associated with the treatment?
6. Are there risks involved?
7. What is the healing rate after surgery?
8. How long must the treatment continue?
9. Length of time between injury and treatment: What effect does this have?
10. Will my insurance cover the procedure?
11. The question of guarantee.
12. Why in Mexico?
13. Is there someone with whom I can speak in Spanish?
14. Can I visit your facility?
15. What are the disqualifiers for the program?
16. Does everyone need to have surgery?
17. How soon will I start recovering?
18. How long is the post-surgical recovery period?
19. Can I receive follow-up treatment in my home state or country of residence?
20. What is the current status of FDA approval for the treatment?
21. Are research laboratories studying embryonic cell therapy?
22. Does Christopher Reeve know about this treatment?
23. How can I get additional information on what you do?
24. Conclusion

How does this procedure differ from other treatments?
The real advance of this procedure has been the "marriage" of five separate procedures, including 1) traditional decompression surgery that reconstructs the boney structures of the spinal canal so that it normalizes the support structures for the spinal cord, 2) microsurgery that removes impingements upon the spinal cord, such as scarring tissue, cysts and metallic objects (e.g., bullet fragments), 3) the introduction of live embryonic cells that gradually regrow the neural matrix across the injury site and, later, at progressively lower levels along the spinal cord that may have become atrophied from lack of use or the reduction of nutritional ingredients normally carried by the spinal fluid, 4) specially designed cyst reducing shunts, and 5) the use of scarring inhibitors and growth enhancing, including remyelination, factors.

If the procedure works so well, why isn’t everyone using it?
Admittedly, the procedure is not yet well know. The clinical foundation for the procedure has been progressing quietly for nearly a decade. The physicians doing this work were initially as surprised at its effectiveness as are many contemporary observers. Gradually, this information is being shared at professional meetings in which animal research is providing support for these clinical findings. Nevertheless, it will take time for the views of traditional medicine to become comfortable with the idea that there is actually hope for the spinal cord injured.

Why do you use embryonic rather than fetal cells?
Embryonic cells are utilized for several reasons. They appear to be "site specific," traveling to the anatomical zone associated with that part of the lender organism used for the cell culture. For example, embryonic spinal cells migrate to the spinal cord of the human host. This has been shown to occur even when the cells are injected intramuscularly. In addition, there have been no cases of "host rejection" of embryonic cells, which may occur when fetal cells are used. When embryonic spinal and brain cells are injected at the injury site, and at progressively lower levels as sensory and motor function increases, they produce new growth that forms a neural matrix capable of receiving sensory and motor signals from the human central nervous system.

Why do you use the blue shark as the donor organism?
There are four important reasons for using the blue shark as the donor organism. First, this choice avoids the ethical and moral issue associated with human embryonic cells. Second, the blue shark is a large donor that provides more material for productive use. Third, the blue shark has an unusually strong immune system, which mitigates against viral and bacterial transfer to the human host. Finally, the blue shark has a nine month gestation period, making it biologically similar to the period of human gestation.

Are there side effects associated with the treatment?
We have observed no side effects associated with this treatment. For example, live embryonic cells are accepted by the body, while fetal cells may be rejected. There have been no instances of runaway growth, such as benign or malignant tumors. These clinical findings are also supported by independent animal research.

Recent nonprescribed drug use by the patient, however, may influence response to surgical anesthetics. This should be discussed frankly with the physicians prior to treatment to avoid complications.

Are there risks involved?
There have been no instances of any loss of function as a result of the surgery. In part this is due to the care with which patients are selected. If there is any perceived risk to function, the patient will not be accepted.

In addition, the surgeons are highly experienced and conservative in their medical approach, and strictly follow generally accepted medical and surgical protocols.

The instrumentation used during surgery is new and is comparable to any in the United States.

What is the healing rate after surgery?
When the recommended therapeutic regimen is followed, new neural growth proceeds at the approximate rate of one centimeter per week. The optimal rate of implantation is once every two weeks.

In addition, patients often report several centimeters of new function immediately following surgery and the initial implantation of live embryonic cells. Some of this may be due to decompression of the spinal cord and reconstruction of the boney structures of the spine. These effects, however, are individualistic, and will vary depending on the level and nature of the original injury and the after-injury care the patient had received prior to this treatment.

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.

Why in Mexico?
The answer to this question is best answered by referring to a letter written previously to one of our patients. It refers to the stance the FDA has taken toward procedures that are yet to be approved.

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

I hope that these answers will assist you determine whether this procedure is something that you want to pursue further.

There are two important facts about the International Spinal Cord Regeneration Center  that I want you to know before you proceed.

First, the ISCRC is a medical clinic located in and operating within the laws of the country of Mexico.  All physicians and surgeons working with the ISCRC are licensed by and are working within the country of Mexico and are subject to its laws and regulations. The exceptions are those physicians who have previously evaluated a patient who resides in a country other than Mexico, or who holds a valid medical license from another country but who has evaluated a patient or prospective patient of the ISCRC.  These physicians, however, are not staff members of the ISCRC. Second, the American Food and Drug Administration (FDA) has neither evaluated nor approved any procedure, medical or otherwise, described on this web site or in other promotional materials.  Neither the efficacy (effectiveness) nor the safety or reliability of these procedures has been evaluated by the FDA.  Although we have previously described the use of Blue Shark Embryonic Xenotransplants as a medical treatment, we hereafter make no claims of medical efficacy or safety of this approach. Although both the ISCRC clinic and its staff of physicians are licensed and bound by the laws of Mexico, they nevertheless are currently seeking ways to evaluate these treatments in accordance with the rules, regulations and preferences of the American FDA.

How to reach International Spinal Cord Regeneration Center
International Spinal Cord Regeneration Center

Bonita California 91902

Email: Send email

To receive additional information call
(619) 463-5350 FAX (619) 460-2699
Ask for Dr. Robert Lewis

ISCRC Office Phone (011 52 66) 83-29-44