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Questions and answers about stem cells:
(from the Hospital in China)


What is a Stem Cell (SC)? A stem cell is a cell that can renew itself and become other types of cells in the body. This ability to change into other types of tissue is known as “plasticity”.

What is a cord blood? Cord blood is collected for the baby’s Umbilical Cord after birth. Beike Bio-Tech has performed thousands of these types of collections. All cord blood is tested for infections and possible abnormalities prior to use.

Are stem cell transplants from cord blood safe? Yes, in fact doctors have been using these types of stem cells for over 40 years. The National institute of Health (NIH) has stated that they have seen no cases of cancer or other health issues in relation to this type of transplant.

How soon will I see results? Some patients have noticed improvement within 24 hours. Since this is too soon for the cells to have engrafted we believe these immediate results occur from the Neural Growth Factors used during the transplant process.

What should be done to prepare for a Stem Cell Transplant (SCT)? We advise that you undergo no drastic changes in medication I month prior to treatment, surgery should not be done at least one month prior to treatment and it is advised that you not receive immunizations at least one month prior to treatment.

What are the side effects of a SCT? The side effects are very minimal. Most common is a slight elevation in temperature lasting 12 to 24 hours. Some patients also experience mild to moderate headaches. Many recipients also experience some level of fatigue for a day or two.

What is the FDA’s position on Umbilical Cord Blood Stem Cells? The FDA has approved the use of these cells for over 80 conditions. Unfortunately approval for many illnesses and conditions has been slow to come which is why so many are opting to go outside the US for treatment.

Can you guarantee this treatment will work? No, there are simply no guarantees. People respond differently to treatment as there are so many variables to consider. There are however consistencies within all of our patients in regard to improvements.

Can I use my own cord blood or that of my own child’s? No: You can not transport blood products into the country. They have been frozen which lowers the viability of the cells. Our products are all processed fresh and never frozen. There is no quality control on a product from another lab.

How many patients (Chinese and foreigners) has Beike treated thus far? As of January 2008 we have treated approxiamatky 2500 patients.

In the years Beike has been working with umbilical cord stem cells has there been any cases of patients developing abnormal growths or tumors? No

Have any of Beike's patients suffered severe rejection? No

Have any of Beike's patients died as a result of treatment? No

Does Beike have plans to expand into the US and/or Canada? That process would take many years and several million dollars and this would not be cost effective as doing so would force the prices to be greatly increased.


Can you please explain what is the Nerve Growth factor and the importance of this in Stem Cell Therapy? Nerve growth factors in regards to those used in China are taken from the cord serum and encourage the growth and repair of neurons as well as enhancing the potential of the umbilical stem cells which are infused.
Can you please also explain the significance of the Cord Serum? It is full of many types of growth factors and a wide array of stem cells.
Is Beike doing research into other ways to regenerate white matter? Yes, we are currently conducting research and development of a product based with Amniotic Stem Cells that is looking promissing and hope to be able to offer this to clients in the latter part of 2008. We have also been refining the culture and processing techniques for bone marrow transplants using the patients own bone marrow and have installed a new bone marrow lab at out Hang Zhou facility. Currently we are doing bone marrow transplants only on adults and children with MD but hope to expand this as an option for other children over the age of 8 within a few months.

The Lengthy Version: Do cord blood cells need to be DNA matched and embryonic/fetal stem cells not? It is a misconception that embryonic and fetal cells do not have a fingerprint and can change into any type of cell while umbilical stem cells do have fingerprints and can not transform. It is incorrect to say that this leads to rejection issues with umbilical stem cells as it does not. As for references made to such things as "DNA" and/or "fingerprints" neither really applies to either type in their true and pure forms. It isn't DNA variations per se, but surface antigens, often referred to as "markers", that signal "self" from "other". "Self" being the bodies own matter and "other" being a foreign substance. The consensus of studies published in scientific literature is that human umbilical cord stem cells (hUCSCs) provoke little in the way of adverse reactions due to antigenic recognition by the recipient. Meaning that because they lack markers and the body sees them as "self". This is why anti-rejection medication is not needed when doing a SCT with hUCSCs in the manner that is done by Beike.

How do you make sure that the stem cells you are using are a match for the patient and will not be rejected? Umbilical Cord Stem Cells, aka UCSC’s, do not require matching. In the life span of a stem cell umbilical cord derived stem cells are considered to be the youngest or least mature of all the stem cell types. These UCSC's (Umbilical Cord Stem Cells) simply lack the exterior surface antigens (protein markers) which would indicate to the hosts body that the cell is “other” thus the recipients immune system sees it as “self”. Upon being transfused into the body the UCSC’s will of course be noted by the hosts immune system which will respond by releasing white blood cells, aka WBC’s, in effect sending these white blood cells out into the body to do a search for foreign substances. Upon encountering the stem cells the white blood cell (WBC) will literally bounce around the exterior of the stem cell checking it for very specific proteins which are attached to the cell’s exterior cell body. These proteins are considered a type of antigen marker. When the WBC can not locate the “foreign” antigen markers it reads the new stem cell as “self”. This allows the host’s body to receive the Umbilical Cord Stem Cells with no fear of rejection and thus no matching is required and “rejection” is not an issue.

What are stem cells? Stem cells are unspecialized cells that have two important characteristics that distinguish them from other cells in the body. First, they can replenish their numbers for long periods through cell division. Second, after receiving certain chemical signals, they can differentiate, or transform into specialized cells with specific functions, such as a heart cell or nerve cell.Stem cells can be classified by the extent to which they can differentiate into different cell types:
  1. Totipotent stem cells can differentiate into any cell type in the body plus the placenta, which nourishes the embryo. A fertilized egg is a type of totipotent stem cell. Cells produced in the first few divisions of the fertilized egg are also totipotent.
  2. Pluripotent stem cells are descendants of the totipotent stem cells of the embryo. These cells, which develop about four days after fertilization can differentiate into any cell type, except for totipotent stem cells and the cells of the placenta.
  3. Multipotent stem cells are descendents of pluripotent stem cells and antecedents of specialized cells in particular tissues. For example, hematopoietic stem cells, which are found primarily in the bone marrow, give rise to all of the cells found in the blood, including red blood cells, white blood cells, and platelets. Another example is neural stem cells, which can differentiate into nerve cells and neural support cells called glia.
  4. Progenitor cells (or unipotent stem cells) can produce only one cell type. For example, erythroid progenitor cells differentiate into only red blood cells. At the end of the long chain of cell divisions are t
  5. erminally differentiated cells, such as a liver cell or lung cell, which are permanently committed to specific functions. These cells stay committed to their functions for the life of the organism or until a tumor develops. In the case of a tumor, the cells dedifferentiate, or return to a less mature state. The term adult stem cell refers to any cell which is found in a developed organism (such as an umbilical cord) that has two properties: the ability to divide and create another cell like itself and also divide and create a cell more differentiated than itself. Also known as somatic (from Greek Σωματικóς, "of the body") stem cells and germline (giving rise to gametes) stem cells, they can be found in children, as well as adults. Pluripotent adult stem cells are rare and generally small in number but can be found in a number of tissues including umbilical cord blood.[ Most adult stem cells are lineage-restricted, multipotent and are generally referred to by their tissue origin such as a Mesenchymal stem cell, adipose-derived stem cell, or endothelial stem cell etc.

What is cell therapy? Cell therapy can be defined as a group of new techniques, or technologies, that rely on replacing diseased or dysfunctional cells with healthy, functioning ones. These new techniques are being applied to a wide range of human diseases, including many types of cancer, neurological diseases such as Parkinson's and Lou Gehrig's Disease, spinal cord injuries, and Diabetes. Replacing dead cells in the retina with new ones may someday cure even presently incurable eye diseases such as glaucoma and macular degeneration. To understand how cell therapy works, it helps to understand the role of cells in the body.

Why are stem cells important from a medical perspective?

For decades, researchers have been studying the biology of stem cells to figure out how development works and to find new ways of treating health problems. Because stem cells can give rise to any tissue found in the body, they provide nearly limitless potential for medical applications. Current studies are researching how stem cells may be used to prevent or cure diseases and injuries such as Parkinson’s disease, type 1 diabetes, heart disease, spinal cord injury, Duchene’s muscular dystrophy, Alzheimer’s disease, strokes, burns, osteoarthritis, rheumatoid arthritis, vision, and hearing loss. Stem cells could also be used someday to replace or repair tissue damaged by disease or injury.

Since the stem cells are still an implant could not any implant be rejected? Technically we are not “implanting” the stem cells. We have two delivery methods; one is an “infusion” of the cells, growth factors and cord serum into the blood stream and the other is an “injection” of the cells and growth factors into the spinal canal where they then mix with the SCF (Cerebral Spinal Fluid). * We do not infuse or inject any Red Blood Cells. What creates rejection by the host body is the reaction between the host’s immune system and a foreign substance. When any foreign substance is placed into the body our immune systems are activated by a slight elevation in body temperature. Once activated the body alerts a very specific type of white blood cell (WBC). This type of cell will seek out the newly introduced stem cells. Its job is to determine weather the stem cell is a foreign substance. This determination process is commonly referred to as determining “self” from “other’. The WBC’s will literally bounce around the exterior surface of the stem cell. It is physically checking it for very specific protein markers known as “antigens”. These proteins located on the surface of the cell are like a secrete code and if the WBC does not see the right code it will determine the stem cell to be “self” and thus leave it alone to go about its business. Umbilical Cord Stem Cells lack the antigens that would identify them to the WBC as a foreign cell or as being “other”. The body’s immune system sees them as being “self” and no rejection occurs.

Is it true that umbilical cord derived stem cells have a genetic finger print and this leads to rejection issues? No, this is not true. References made to "DNA" and/or "fingerprints” does not apply to this type of stem cell. It isn't DNA variations per se, but surface antigens, often referred to as "markers", that signal "self" from "other". "Self" being the bodies own matter and "other" being a foreign substance. The consensus of studies published in scientific literature is that human umbilical cord stem cells (hUCSCs) provoke little in the way of adverse reactions due to antigenic recognition by the recipient. Meaning that they lack markers and the body sees them as "self". This is why anti-rejection medication is not needed when doing a SCT with hUCSCs.

Grafting vs. Host Disease (GVHD)
GVHD is one of the most common and life threatening side effects of a stem cell/bone marrow transplant. GVHD occurs when the transplanted stem cells recognize the recipient's body as foreign, and "reject" it. Cord blood transplants have had a noticeable lack of GVHD because the stem cells from the donor do not need to match the recipient as with bone marrow.

Do you use chemotherapy or immunosuppressant drugs? No we never use these types of drugs in our treatment process as they are not needed since there are no issues with rejection.



Questions from other Parents that have been answerd by the Doctors in China:


> "The biggest question I have at this point is if the treatment would be available for my son as well, or if this is just a trial or something?" Yes it is available to your son even if he does not meet the parameters of the case study. Given that we already know the treatment is very safe and will do no harm and taking into consideration the amazing early results of the first 3 children that have been treated we have now opened it up to all children in need. We acknowledge that the earlier in life the children are treated the better the results will be and we do not want any child to have to wait to see the aces of thier loved one's.


> "I'm not very comfortable with going overseas, can I get this done in the United States? We do realize that taking your child far across the seas for treatment in a foreign country is incredible and overwhelming for some parents to even ponder. Unfortunately there is no one else any where in the world even attempting to do what we have just accomplished. This is ground breaking, cutting edge treatment that will not likely be available in the US and/or Canada for several years to come. Even if the US began today to attempt to put together a protocol and treatment such as this it would still take 7 to 10 years or more before children could actually receive it even on a limited basis. Children with ONH can not wait 10 years to see. Some children with ONH have do have a visual decline as thier optic nerves continue to atrophy and degrade. For some children this is in fact a "progressive" disorder. Early intervention is a key component in any treatment involving stem cells and nuerons.


> From Julia: What about wiring the brain tissues? How will the kids understand what they see? Known fact > If a baby is born without enough functional eyesight to process the input they do not develop vision. Eyesight is the act of seeing. Vision is the ability to understand what one sees. The stem cells may be able to improve the child’s eyesight but they can not give the child vision. For vision the child must be taught to understand what they see. As part of my protocol I have included a therapy known as Developmental Visual Training. This is based on a therapy approach know as Neurodevelopmental Patterning. It is a type of therapy commonly used with brain inquired children and one I used with my own son. The work aids in teaching the brain to develop pathways around the area of injury such as is the case with a brain injury and/or reactivating dormant portions of the brain and thus creating pathways within a section of the brain that was previously not in use or perhaps in use for another function as is the case with your children. This type of work has been around for well over 20 years and is used worldwide.


> From Julia: Since the stem cells are still an implant could not any implant be rejected? Technically we are not “implanting” the stem cells. We have two delivery methods; one is an “infusion” of the cells, growth factors and cord serum into the blood stream and the other is an “injection” of the cells and growth factors into the spinal canal where they then mix with the SCF (Cerebral Spinal Fluid). * We do not infuse or inject any Red Blood Cells. What creates rejection by the host body is the reaction between the host’s immune system and a foreign substance. When any foreign substance is placed into the body our immune systems are activated by a slight elevation in body temperature. Once activated the body alerts a very specific type of white blood cell (WBC). This type of cell will seek out the newly introduced stem cells. Its job is to determine weather the stem cell is a foreign substance. This determination process is commonly referred to as determining “self” from “other’. The WBC’s will literally bounce around the exterior surface of the stem cell. It is physically checking it for very specific protein markers known as “antigens”. These proteins located on the surface of the cell are like a secrete code and if the WBC does not see the right code it will determine the stem cell to be “self” and thus leave it alone to go about its business. Umbilical Cord Stem Cells lack the antigens that would identify them to the WBC as a foreign cell or as being “other”. The body’s immune system sees them as being “self” and no rejection occurs.






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