Some Facts About Our Unique Stem Cell Therapy
1. What are stem cells and how do they work in the treatment of various diseases?
Stem cells are found in most, if not all, multi-cellular organisms. They are characterized by their ability to renew themselves through mitotic cell division and differentiate into a diverse range of specialized cell types.
The mechanisms of how stem cells can treat different kinds of diseases vary, for example, in the treatment of neurological diseases, the stem cells after implantation, have several ways to repair the damaged areas including:
1) The stem cells can secrete nutritional elements and provide nourishment to the neural cells and tissue.
2) The stem cells can locate together around the damaged area and prevent any further damage.
3) The stem cells can differentiate into similar cells such as neurons, neurogliocytes, oligodendrocytes, etc., in the surrounding tissue once they are injected into the patient´´s body and locate to the specific area of damage.
4) The stem cells can attend to the rebuilding of the patient´´s damaged neural network, improving the overall functioning.
5) The stem cells carry normal gene systems which after implantation, have the ability to repair the patient´´s genetic disorder and produce normal proteins, correcting the deficiency.
6) Once the stem cells survive and differentiate inside the patient´´s body, they will maintain the repairing process and proliferation throughout the person’s lifetime.
2. How do stem cells know where to go and what to do?
We have a unique process which directs the stem cells toward the damaged area; we employ gene-targeting techniques. For example, with the treatment of a stroke, the patient will have some neural scarring in the damaged area of the brain. We use a series of medications designed to activate the cells in the scar tissue, allowing these cells to produce some chemotactic signals which attract the stem cells to locate directly to the area of the neural scarring.
3. What kinds of stem cells does your medical center use and are they safe?
We currently use neural stem cells and retinal pigment epithelium derived from a spontaneously aborted fetus and mesenchymal stem cells from either bone marrow (autologous), umbilical cord or cord blood.
In recent years, there are at least three Phase I clinical trials using fetal stem
cells to treat neurological diseases which have been approved by the American FDA that include:
1) For Autism:
2) For Spinal Cord Injury(SCI)
3) For Amyotrophic Lateral Sclerosis ALS(ALS)/ Motor Neuron Disease(MND)
4) For Cerebral Palsy(CP)
5) For Stroke
6) For Eye Disorders
7)For Brain Injury
8)For Parkinson’s Disease(PD)
9)For Muscular Dystrophy(MD)
The stem cells we use for transplant are processed and produced in the SFDA certified GMP facilities. They are in full compliance with the NICPBP (National Institute for the Control of Pharmaceutical & Biological Products, SFDA) standards for clinically used stem cells. This ensures the highest product quality and safety.
4. Where do the stem cells come from? How are they processed and are they in anyway purified? Should there be a concern about them forming into the wrong type of cell and possibility resulting in the formation of a tumor?
The neural stem cells come from the neural system of the fetus (less than 4 months old) and the mesenchymal stem cells are from cord blood,
which are collected and further processed and manufactured by the National Industrial Base of Stem Cell Technology, i.e., the cells are separated, expanded in-vitro and purified under the strictest and effectively controlled environment before they are sealed in vials for clinical implantation. These stem cells will not differentiate into any other kind of cells except neuron precursors.
To date, we have treated just over 1,700 patients and in the past 6 years of administering the stem cell treatment there have been no cases of cell rejection, or the development of tumors.
5. Are stem cells pre-tested for HIV and Hepatitis? What else do you test them for?
Yes, the stem cells have been pre-tested for HIV and Hepatitis, as well as for bacteria, viruses, mycoplasma and the stem cells´´ oncogenicity, etc., so that the safety of these stem cells can be assured.
6. Is stem cell treatment safe? Is it really effective?
We use systemic safety evaluations to control the safety of the stem cell treatment: We started the safety evaluation of stem cell treatment 10 years ago, with a study group of 30 volunteers who participated. Currently, all 30 volunteers are still in perfect health and to date, since 2005, we have treated over 1,700 patients using the stem cell treatment and there has been no single case of major observed safety problems or complications after the stem cell implantation procedure, although there can be some minor side effects associated with the treatment such as headaches or muscle weakness, these can be easily overcome in a short amount of time.
Our doctors are very familiar with the biological nature of stem cells and we can guarantee the safety of the treatment throughout the entire procedure. Strict safety regulations are put in place, for the production of the stem cells, for the quality control of the stem cells prior to implantation, to the strict monitoring after the implantation, and finally in regards to the patient´´s follow up, every detail is scrutinized and the guidelines strictly adhered to.
7. How do I know if I am a good candidate for stem cell therapy?
The first step is to send us your medical records and diagnostic test results. We will then analyze your case. If your disease or disorder does not have a specific treatment program, and the symptoms become increasingly serious, with severe neurological functioning damage, and biotherapy could help with nerve remodeling, improve functioning, change the quality of your life and prolong it, then we will suggest you have stem cell treatment if you don´´t have any contraindications.
8. How long should I expect to stay in Beijing for the treatment?
Generally 4 weeks is required, with 4 stem cell injections via the subarachnoid cavity by lumbar puncture, or a tissue injection such as stereotactic brain injection, intramuscular injection, or intravenous injection. For some other diseases, the hospitalization time is different depending on patient´´s individual situation.
9. Can you use adult stem cells from my own bone marrow?
Yes, if you do not have a genetic or hereditary metabolic disease, and you are young enough, we can use your own bone marrow stem cells.
10. Can you explain how your hospital extracts and processes stem cells?
We extract stem cells by using several different methods. Some examples are, separating the stem cells from a patient´´s bone marrow, collection through fetal cord blood, or spontaneously aborted fetuses. The “National Industrial Base of Stem Cell Technology” will culture, proliferate, and differentiate the stem cells to increase their numbers and then transfuse them back into the patients. Our doctors use medications and biofeedback techniques to regulate the stem cells´´ proliferation and differentiation inside the patient´´s body, in order to form the regular synapses and complete the nerve remodeling and repair the nerve damage.
11. Can you explain how stem cells are infused into the body?
We inject the stem cells between the L3-4 intervertebral discs by lumbar puncture: we direct the stem cells to the brain or spinal cord place of injury by CSF circulation. The entire process includes signal induction, receptor orientation, gene regulation and other techniques.
12. How many implantations will I receive during one treatment?
One treatment includes the injection of 5 million stem cells into the subarachnoid space, and the number of implantations is between 3 and 4.
13. What should I expect to experience during the stem cell treatment and what are the risks?
Generally speaking, the patient won´´t feel any discomfort during the stem cell treatment, and their neural functioning will improve gradually. Only a small number of patients (less than 10%) develop a minor fever, headache, nausea, or vomiting. But these reactions won´´t last more than 3 days and they will be controlled in a short amount of time.
14. Do the doctors use anesthesia during the operation?
Most of the procedures only require local anesthesia, and we will use some sedative medication for the nervous patients. The patients will be awake during the operation and it will be a painless procedure that will allow them to communicate to the doctor during the entire process.
15. What other drugs and/or carrier medications does the doctor combine with the stem cells for therapy?
The stem cell therapy is part of the whole treatment. During pre-operation we will use medication to improve the brain´´s microenvironment in order to make sure the injected stem cells can survive inside the body; During post-operation some medication will be used to protect the stem cells from being self-eliminated, and to help the stem cells locate, proliferate and differentiate in the damaged area. At the same time we combine rehabilitation training to help the stem cells develop the desired functions.
16. How long after surgery will it be before I can bathe or shower?
The lumbar operation wound is very small. The patient can shower after 3 days with waterproof bandages to keep the wound protected from the water. If the patient receives the brain stereotaxic injection, he/she can come in contact with water at least one week after the procedure.
17. For Batten disease treatment, I want to know the type of stem cells being used? How many cells? Is there a reason the number of cells can’t be increased? It is my understanding that in the Stem Cells Inc., trial for Batten disease the last 5 patients received 1 Billion purified neural stem cells. Little improvement was observed. The patients were stabilized for a time but improvement was minimal. 20 Million is 2% of the cells used in the US trial, why are these numbers so different?
For the treatment of Batten disease, our doctors prefer to use neural stem cells, and in the treatment procedure, there are 4 separate stem cell injections (once per week) with 5 million stem cells in each injection. According to our clinical research and laboratory tests an individual can only handle a limited number of stem cells from external sources effectively. For children suffering from Batten disease, 5 million stem cells in each injection is the most effective number. If we implanted more stem cells into the patient´´s body there would be no improvement but it would add to the cost and more importantly, it would add a risk of developing encephalitis and other side effects.
18. Tell me more about the "cocktail" or neural growth factors that you use before the stem cells are administered. Would it be possible to administer this product in the USA at intervals between trips to China for stem cell treatments? How often could it be administered?
The "cocktail" treatment is unique and very effective and was developed by Dr. Wu and Dr. Wang. It combines a group of medications. The combination and the dosage of the medications are changed at various intervals throughout the treatment process and are dictated by the patient’s condition.
The "cocktail" treatment focuses on adjusting the neural-immune-endocrine system:
1) Before the stem cells implantation, a series of medications are used to prepare the brain´´s internal environment to ensure the stem cells have the best opportunity for growth.
2) Certain medications are used to induce the damaged area into producing special signals that attract stem cells after the implantation. (The stem cells are attracted to the damaged area and begin the repairing process with the damaged neurons).
3) Medications such as neural growth factors assist in the differentiation of the stem cells to help the new neurons express normal functioning in the patient´´s body.
19. From other parents I have heard some hospitals have an age restriction on patients that they will treat with stem cells. Do you have similar restrictions? What is the reason for these restrictions?
Previously, the minimum age for stem cell treatment was 3 years old. This age was imposed by Dr. Wu´´s medical team because the stem cell treatment technology was not as advanced at that time. Now the treatment technology is far better and completely safe and our medical center has now treated patients as young as 4 months old. The safety while treating such young patients can be guaranteed because of the increased effectiveness and development of the stem cell treatment technology over the past several years.
20. What class/type of anticonvulsants or anti-seizure medications do you use on Batten disease patients?
To treat Batten disease patients the doctors prefer to use anti-seizure medications with a less toxic effect. First, they will choose a more effective medication to control the seizures; second, they will adjust the dosage of the current medication to reduce the damage to the liver functioning and renal functioning. After being admitted to our hospital, the doctors will assess the patient and choose the proper medications and dosage for the treatment. Everything is individualized.
21. Is it possible for you to manufacture the TPP1 enzyme and deliver it with a shunt or via lumbar puncture?
The stem cells, after implantation, can produce the TPP1 enzyme themselves. They come from normal genes. Also the stem cells, after implantation, can suppress the part of the defective expression of the TPP1 enzyme in the body.
22. When I send my records to your hospital, does a doctor read my medical information?
When your records arrive at our hospital, we will send them to an appropriate neurological stem cell doctor (one of a few experts who can control stem cell generation, growth, expression function and transformation).The doctor will evaluate your neural functioning, and design an appropriate treatment plan for you.
23. Is general anesthesia used?
We ordinarily do not need to use general anesthesia.
24. Is other therapy done in addition to stem cell infusion?
The stem cell treatment includes ectogenic stem cell transplantation with corresponding medication, including oral and venous medications, and the biofeedback is a very necessary part of the therapy as well.
25. What types of rehabilitation training is done?
The rehabilitation training is a necessary part of the overall stem cell treatment. The rehabilitation doctor will give the patient Physical Therapy, Occupational Therapy and Speech Therapy according to the patient´´s needs. These therapies will help the injected stem cells to have more accurate and effective functioning.
26. What will my treatment schedule be like?
The treatment schedule will be designed according to each patient´´s unique medical condition. In general, the duration of the treatment is 3-4 weeks long. Ordinarily, during the first week we perform necessary examinations, and make the preparations for the stem cell infusion, including improving the microenvironment, cleaning out the toxins, nourishing the nerves, and doing rehabilitation training. After that we transplant the stem cells and begin to do some post-operation treatment, including immune and endocrine regulation, etc., to make sure the infused stem cells can survive, and to promote cell proliferation, differentiation and improve neuro-functioning. The stem cells will be implanted once per week.
27. Does the doctor have to penetrate the spinal canal to infuse the stem cells?
Yes, but the stem cells are infused by a highly experienced neurologist.
28. If I have to have surgery, how long will it take for the wound to heal?
Patients undergoing the lumbar puncture procedure need to rest in bed for 6 hours without a pillow, after the surgery. If there is no discomfort after that time period, the patient can participate in some light activity after 2 days.
29. Will I lose very much blood?
The stem cell implantation procedure will not cause much blood loss, commonly less than 10ml, so the patient will not need a blood transfusion, except in the cases of severe anemia or a blood disease.
30. If there is surgery, can I fly back home before the wound has healed?
The lumbar operation patient would not be able to fly home before the wound has healed. The patient will stay in the hospital for some time to make sure the stem cells can survive and differentiate. When the patient is discharged, the wound will have completely healed and they can fly home at that time.
31. Tell me about your research with brain protection therapy. Are you able to protect the myelin sheath?
The treatment not only protects the myelin sheath, but we also use a series of medications to protect the whole neuronal cell body: the medications can clear away oxygen radicals, anti-EAA and protect against calcium overload.
32. Does your medical center also offer conventional treatment besides stem cell therapy?
Our treatment program is a combination of conventional medicine and stem cell therapy, but we do offer conventional treatment, especially for the patients with certain neurological conditions caused by non-neural degeneration or non-inherited diseases such as post-stroke, brain trauma, etc.
There could be a significant difference between the conventional treatments. For example, to treat a post-stoke patient, the principal therapeutic goal of conventional medicine is to prevent a recurring stoke, by removing the risk factors, while our stem cell therapy would allow the restoration of some of the lost brain functioning by re-establishing the neural connections.
In our center, it’s basically the patient’s decision whether they want to have only the conventional medicine or a program that combines both conventional and stem cell therapy. We have also successfully treated over 100 post-stroke and brain trauma patients with conventional medicine only.
33. What is the most effective way to contact us?
Our hospital´´s fax number is +8610-83614168. However, the most effective way to send your medical information is by email( firstname.lastname@example.org ), which can be processed more conveniently, so that our specialists can quickly receive it and make a treatment plan in a shorter amount of time.