Cayden Towery

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Cayden's Stem Cell Experiance

What are stem cells? Where do they come from?

"Stem cells have the remarkable potential to develop into many different cell types in the body. Serving as a sort of repair system for the body, they can theoretically divide without limit to replenish other cells as long as the person or animal is still alive. When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell." From the National Institutes of Health (NIH) Stem Cell Information website:

http://stemcells.nih.gov/index.asp

There are 4 main sources of stem cells:

1)    Fertilized egg derived stem cells (called embryonic stem cells in the press)

2)     Stem cells taken from aborted human fetuses (a human fetus up to two months of age is an embryo),

3)     Umbilical cord blood and

4)     Adult bone marrow & other adult tissues (adipose, skin, etc).

For more info on umbilical cord stem cells go to:
http://www.stemcelltherapies.org/stemcells1.htm

What’s wrong with having treatment with embryonic stem cells abroad?

Quality control and assurance is a major issue with so-called (fetal) embryonic stem cell therapy abroad. The materials being used apparently come from aborted fetuses. When questioned about the QC/QA (Quality Control/Quality Assurance) used to insure that the stem cells they advertise are actually CD34+/CD133 progenitor cells, those involved in use of embryonic stem cells invariably do a song and dance. We at SRI have yet to meet one rep or medical director involved in so-called embryonic stem cell therapy who was willing to provide specific QC/QA certificates of analysis or any copies of lab tests for various infectious diseases. So far, SRI has heard only hype, no actual facts in written form.

The umbilical cord stem cells utilized by Dr. Morales, on the other hand, are processed using the very highest standards and state-of-the-art technology in the world. The cord blood is only collected from healthy mothers who give birth to full term, normal, healthy babies -- which is then screened for all major communicable diseases. Blood that passes muster at this level is then sent to the lab where skilled technicians use special technology to separate CD34+ CD133+cells. These progenitor cells are then expanded in a medium that is free from any animal products (No mouse feeder cells or other animal serums). After peak expansion is reached, the stem cells are frozen in liquid nitrogen and stored. (Certificates of analysis are furnished to researchers by the lab where the umbilical cord blood stem cells are produced).

On to safety concerns: Fertilized egg derived and aborted fetal embryonic stem cells have only been used for less then a decade, mostly by scientists doing research in lab animals. No one really knows what secondary diseases or cancers may arise 20 years or so down the line. Umbilical cord blood stem cells have been used for over 16 years in the treatment of leukemia with virtually no secondary diseases or cancers.

http://14ushop.com/wizard/Embryonic-stem-cell-8-1-04.html

And......from "Stem Cell Research: Slow but Steady Progress" (Oct. 9, 2004)

"What is seldom discussed, however, is that embryonic cell transplantation remains experimental, with glimmers of hope but few benefits to current medical care. There have been no human clinical trials using embryonic stem cells. Even successful animal experiments continue to report tumor growth, host-source incompatibility or rejection and perplexing anomalies. Furthermore, while mice stem cells are relatively easy to work with in laboratories, human stem cells are not, experts say."

For a More Extensive Look at the Scientific Problems that attend Embryonic Stem Cells: http://www.stemcellresearch.org/facts/quotes3.htm

Why are scientists focused on embryonic stem cells and not umbilical cord stem cells?

Many scientists argue that embryonic stem cells are pluripotent, i.e., can give rise to any cell or tissue, while umbilical cord stem cells are far less so. This position has been challenged by findings reported in published studies in mainstream peer-reviewed journals and elsewhere – especially our observations of clinical experiences using these in a variety of types of cases:

Stem Cells from Human Umbilical Cord Blood Show Ability to Form Bone, Nerve and Heart Cells, BOSTON, July 19 /PRNewswire

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/07-19-2004/0002212680&EDATE=

And there is an element of bias insofar as funding is often controlled by agencies that either have vested interest in embryonic stem cells or else have some other kind of blinders on:

http://www.worldmag.com/subscriber/displayarticle.cfm?id=10284

Is the use of human umbilical cord stem cells illegal in the USA?

Cord blood and many other forms of adult stem cells are approved for use in treating a number of diseases and conditions including leukemia in the United States. However, the FDA has not approved cord blood or cord blood stem cells for the treatment of neurological diseases, disorders or injuries.

How is it that American doctors can’t get the umbilical cord stem cells, and foreign ones can?

American law allows labs that process hUCSCs to dispense them only to scientists and physicians engaged in FDA approved animal studies and human clinical trials. It also permits shipment of the cells to researchers and physicians outside the USA who are doing approved research or application under their particular country’s laws. Dr. Morales is allowed to use human umbilical cord stem cells in human patients under Mexican law.

Why can’t I use my own cord blood or that of a relative and have stem cells made up just for my use?

There are a number of reasons this is not doable: (1) Cord blood and the stem cells derived from it is regulated by the FDA as a biologic (Treated like a drug). It is illegal for the cord blood bank to give the stem cells back to the family for the family to use (even on that child who should be the rightful owner and recipient for any condition other than for an FDA approved condition).

While it is acceptable for cord blood labs to procure donated blood to make stem cell production runs for dispensing to scientists doing approved research, they cannot do so for individuals. This would be like the drug giant Merck making a special drug at the request of a consumer! (2) It is cost-prohibitive. The production of stem cells is labor-intensive – which is to say many technicians and scientists are involved. For a lab to devote its resources and manpower to a "special order" would entail some hefty costs. And last but by no means least: (3) Donated cord blood used to make the stem cells used by Dr. Morales comes from healthy mothers who’ve given birth to healthy babies and the blood is screened for all major diseases (American Association of Blood Bank standards http://www.aabb.org/All_About_Blood/FAQs/aabb_faqs.htm#5). Furthermore, since the final "end product" (pure umbilical cord stem cells) has no blood present, cross-matching and such is unnecessary [In over 100+ patients treated by Dr. Morales to-date no rejection or other adverse reactions have occurred. A few patients have had mild responses to growth factors contained in the liquid media that houses the stem cells, but these were readily managed with oral Benadryl ® and such]

Where does Dr. Morales get his human umbilical cord stem cells (hUCSCs)?

The cord blood is donated by mothers in a major hospital on the east coast and is then processed in a medical school-affiliated, state and FDA approved laboratory that uses state-of-the-art technology to extract, expand, and freeze the umbilical cord stem cells (hUCSCs).

How is donated blood screened and processed?

Human umbilical cord stem cells utilized by Dr. Frank Morales comes from healthy mothers who've given birth to healthy babies. It is routinely screened and processed according to FDA and American Association of Blood Bank (AABB) standards:

http://www.fda.gov/cber/gdlns/celltissue.pdf - FDA tissue and cell screening protocols (37 pages)

http://www.aabb.org/All_About_Blood/FAQs/aabb_faqs.htm#5 - American Blood Bank Screening Standards

Blood that passes muster is then processed for removal and culturing of the progenitor (stem) cells using state-of-the-art technology such as:

 http://www.stemcell.com/product_catalog/stemsep.asp

How many stem cells are contained in the vials used by Dr. Morales?

Using a sophisticated technique called flow cytometry, the lab technicians place ~ 1.8 million stem cells in each vial that is destined for use by Dr. Morales. Allowing for a small percentage of die-off during thawing, more than 1.5 million cells are "alive and kicking" at the time of treatment.

How are the stem cells given?

Most infants and small children are given the stem cells via a subcutaneous injection into the tissues adjacent to the belly button. Older children and adults are typically given stem cells by IV drip (A process that lasts about 20 minutes)

Why is a subcutaneous injection used on most children, and an IV approach in most adults?

Many years of injecting cells subcutaneously near the umbilicus (belly button) has shown that this method does produce notable results. It appears the cells migrate slowly out from the injection site and enter the circulation – over a period of hours and even days. Since an IV approach is not always easily done on some patients – especially infants and small children – the "subQ" approach is routinely employed on these patients.

In older patients – as well as some children – direct introduction of the cells into the circulation via IV is used. There are some neurological conditions for which a direct infusion of cells into the circulatory system is deemed the best approach to treating the patient.

The use of a subcutaneous, IV or combination route is decided by Dr. Morales based on his clinical judgment and past stem cell patient responses.

What’s the soonest people have reported seeing improvement or other change following hUCSC therapy?

Some have noticed changes within as little as one hour following treatment. For example, Dr. Morales treated a small child with cerebral palsy using hUCSCs in his clinic in Progreso, Mexico. The child went to sleep almost as fast as the cells went in (SubQ), then perked up within 30 minutes and began moving her head and arms in ways she never had been able to do previously. The effect persisted (No regression). However, most people will not see changes for at least three weeks but usually the beneficial results begin to appear between the third and sixth month after treatment.

What’s the average length of time until some improvement or such is seen (If there is going to be any)?

Patients typically report noting changes around the 3rd to 4th week after treatment.

What’s the longest period from treatment until something was noted?

A few patients have reported change first being seen or manifest at 9 to 12 months following treatment.

As a rule of thumb, when are most of the changes that will take place (if any) seen?

Most major changes are seen during the first 180 days following treatment. They plateau and then diminish over time, although some patients report seeing benefits cropping up more than 1 year following a single treatment.

In the case of those patients who saw results almost from the moment the cells entered their bodies, how can the stem cells work that fast?

There is no way the cells could engraft, differentiate and begin "doing their thing" in a matter of minutes – or hours. It is felt that the initial results are attributable to growth factors present in the liquid that houses the stem cells. Also, the cells themselves may "provoke" the body to create growth factors and other compounds that foster healing and better function.

Is it stem cells becoming new neurons which underlie reported healing and recovery? Or something else?

First of all umbilical cord stem cells almost immediately after injection begin to produce a specific growth factor (GDNF=glial derived growth factor) which has the power to rescue neurons from a lack of oxygen such as what happens when the person has a stroke or traumatic brain injury. This GDNF activity can rescue up to 60-70 % of dying neurons if given soon after the injury. In later stages and in younger patients such as those suffering from cerebral palsy, one type of stem cells has a tendency to become "white matter cells". These cells make up the "wiring" that connects one neuron to the next and to the muscles of the body. When you look at a cross section of the brain the white matter makes up about 60% of the brain’s inner volume. The gray matter is the neurons which are spread over the surface of the brain.

By looking at the MRI or CT scans of the brain, it is often possible to determine which type of stem cell or combination of stem cells should be used for a particular patient. This is because the CD34+CD133+ cells tend to become white matter (glia cells) and blood vessels while the neural progenitor cells tend to become neurons.

Besides rescuing dying tissues by the action of GDNF, they also save cells by a process called "cell fusion". In this method, the stem cells seek out sick and dying cells and melt their body into the dying cells body. This combo cell winds up with the vitality of the stem cell including its cell nucleus. Many cells thus may have two whole sets of chromosomes – a condition called a diploid state (twice the normal numbers of chromosomes). These diploid cells have been studied and have been found to be stable for many years and do not cause cancer or other problems.

How do the stem cells know where to go in the body?

Stem cells home in on specific chemical signals given off by injured, damaged or diseases tissues or organs.

What can be done if the injury or condition is old and may not be producing these signals?

When these signals are weak they require intervention to increase their numbers (Amplification). This is done in several ways as a prelude to stem cell therapy. Steenblock Research Institute’s director, physician David A. Steenblock has pioneered ways to amplify these chemical signals. This body of work forms the heart of a pre-stem cell treatment program that is offered as a comprehensive 3 to 35 day outpatient program, through the auspices of his private practice in Mission Viejo, California www.strokedoctor.com  1-800-300-1063.  

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Courtesy of the Steenblock Research Institute and Dr. Frank Morales

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