Meningitis damage repaired with adult stem cells

A 20 year old young man from Bedford, Texas was about to lose his arms and legs due to the clotting of blood in his vessels caused by meningitis but no longer.

The treatment involved doctors and technicians at Parkland Hospital in Dallas, Florida, Israel and the Dominican Republic, and one aunt with a computer search.

(While it's wonderful that this young man was rescued, I can't help but wonder how many other experiments are going on in other countries, led by US doctors. Remember that Dr. Wilkerson of Houston did his first experiments using adult stem cells in Brazil.)

From the Fort Worth Star Telegram (Free subscription required):

Lampkin's medical odyssey has taken him from his home in Bedford to a hospital in an island country for a treatment the U.S. Food and Drug Administration has not approved.

Sudden onset
It began when Lampkin, a freshman attending Cisco Junior College on an athletic scholarship, returned home for spring break.

That Friday he was fine. But on Saturday while visiting friends, he complained of having a headache and went to bed early, said Michelle Gideon, Lampkin's godmother.

The next morning -- Easter Sunday -- she found him lying on a bedroom floor.

"One side of his face looked totally normal, but the other side was swollen and looked like he had chickenpox," she recalled.

Lampkin was rushed to Harris Methodist H.E.B. Hospital, where he was treated for bacterial meningitis. Those chickenpoxlike spots were signs of clots cutting off blood flow.

Antibiotics helped stabilize Lampkin, who was transferred to Parkland Memorial Hospital in Dallas.

There doctors planned to amputate his legs at the knees and his arms at the elbows.

But an aunt searched the Internet for other treatments and found Grekos, who was using adult stem cells to stimulate tissue regrowth, improve circulation and reduce diabetic amputation rates. Grekos, director of cardiology and vascular disease at Regenocyte Therapeutic in Florida, flew to Dallas to escort Lampkin and his mother to the facility.

"If there was any hope of helping this young man we wanted to offer it," he said.

Once Lampkin was in Florida, his blood was drawn and sent to a lab in Israel.

Although it was Passover and the lab staffers were on vacation, they agreed to process the blood, Grekos said. The cells were then replicated into millions of super cells that Grekos' company has branded "Renocytes." The cells can become almost any type of new cell or tissue, he said.

Follow-up: HPV Testing, Men, and Prevalence

I did a little research on testing for HPV, especially in men.

The CDC site on HPV is here and it's up to date. http://www.cdc.gov/std/HPV/STDFact-HPV.htm

Digene, http://www.digene.com/labs/labs_hpv_01.html is a swab test for women. Negatives are true negatives for current risk of cancerous changes at the cervix. If negative, then 99.5% accurate - no HPV present at that time. (Can not rule out past infection, but only 1 in 1000 chance of cancerous changes without active infection.)

There is no approved test for males. A few urologists will test with the Digene test - but it's not very sensitive and can miss a lot of disease.

There is a blood test for some of the strains of HPV. However, one article (free online) states that less than 60% of the women who had HPV never become "seropositive."

The new article in the Journal of the American Medical Association from March on the numbers of infection in women is free at http://jama.ama-assn.org/cgi/content/full/297/8/813
Table 1 is very good - and look at the married women: infection rate is 17%. However, for those who said they'd never had sex, the infection rate is 5% and for those with only one partner, 11%.

More on HPV, mandates, and tax money

All State Medicaid programs must offer the vaccines recommended by the (Federal) Advisory Committee on Immunization Practices, under the Vaccines for Children program. The States don't have to mandate the vaccine, however.

Some of the docs I've talked to are convinced that Medicaid and uninsured patients will have an easier time accessing and affording Gardasil than insured patients - unless the insurance companies are forced to cover it somehow.

I predict that within just 2 or 3 years, the private insurers will see that the girls who receive the vaccine don't have to have nearly as many repeat paps, fewer colposcopies and biopsies. Eventually, in 5 or 6 years, there will be fewer freezing and laser therapy treatments. Somewhere in there, they will begin to cover and strongly encourage the vaccine, without being forced.

It turns out that the transition from infection with the more virulent strains to a precancerous or even carcinoma intraepithelial neoplasm (cancerous cells in the surface layer - the kind that leads to repeat pap smears, colposcopy and biopsies and then freezing or laser ablation or removal of the surface layer of the cervix. The pathology-reported names given to these spots on the cervix include "Low Grade Squamous Intraepithelial Lesions, High Grade SIL, Carcinoma in Situ ) can occur within 2 to 3 years, although most take 10 years or so.

From an article available here, free on line,

The traditional view has been that this process takes years, if not decades, to occur after initial HPV infection. Recent studies suggest that these changes may develop more quickly than previously thought. Winer et al followed women after initial HPV infection for the development of CIN 2/3.

As shown in Figure 3, approximately 27% of women with an initial HPV 16 or 18 infection progressed to CIN 2/3 within 36 months [20]. A second study of a large health maintenance cohort found that approximately 20% of women 30 years of age or older who were initially infected with HPV 16 developed CIN 3 or cervical cancer within 120 months.

Women who had an initial HPV 18 infection had approximately a 15% risk of developing CIN 3 or cervical cancer at 120 months [21].

The strong correlation between infection with high-risk types of HPV and LSIL, HSIL, and cervical cancer suggests that HPV DNA testing would be a useful tool for the management of women with abnormal Pap test results, especially in the case of those with equivocal test results. In the case of an equivocal Pap test result, HPV DNA testing can help determine whether the individual should be referred for colposcopic assessment [22].

(Ault, Kevin. "Epidemiology and Natural History of Human Papillomavirus Infections in the Female Genital Tract." Infect Dis Obstet Gynecol. 2006; 2006: 40470. Published online 2006 January 30. doi: 10.1155/IDOG/2006/40470. Copyright © 2006 Kevin A. Ault.)


The biggest financial gain to the Medicaid program and then the insureres - as well as the biggest gain in decreased worry and actual pain and suffering of women - will not be from a decrease in diagnoses of the cancer, itself. It will be from the decrease in the visible warts, as well as precancerous changes from the occult infections that can't be seen with the naked eye and the repeat testing and biopsies, along with the cervical damage from excisions, lasers and freezing which can lead to infertility and premature births.

More information at this summary of another research paper. And this paper reports on 2 year risk of developing CIN.

Med Associations Announce Position Statements on HPV Vaccine

Washington State is planning to offer the Human Papilloma Virus vaccine free to girls. New Hampshire has made the vaccine available on an "opt in" basis. Florida's Legislators are considering following Texas Governor Rick Perry in making the vaccine mandatory, with an "opt out" option, similar to the way that Hepatitis B and other mandated vaccines are regulated. (The vaccine would also have been mandatory under the bills that had been introduced in the Texas Legislature before the Governor's Executive Order.)

Two letters (via email) concerning the HPV arrived since yesterday, one from the Christian Medical and Dental Association and the other from the American Academy of Family Physicians. There is also a newspaper article that covers the Statement of the Texas Medical Association. (I'm a member of each.) Another group forwarded the statement from the Catholic Medical Association.

All encourage the voluntary use of the HPV, because of the safety and efficacy of the vaccine and the ethical practice of preventing disease. And all discourage making the vaccine mandatory.

The Catholic Medical Association (CMA) statement is available online, but in "Macromedia FlashPaper" form, which I've never seen before. The statement is well thought out, with excellent ethics and medical basis. The short statement explained by the 5 page document is:

Does the CMA Support Use of the HPV Vaccine?
The CMA supports widespread use of Gardasil for girls and women in the age range for which the vaccine has been recommended by the ACIP, because it is effective, safe and ethical to use, provided certain conditions are met.

Those conditions include continued teaching concerning abstinence outside of marriage and allowing parents to give informed consent.


The Christian Medical and Dental Association gives the following analogies:

The condom, safe-sex message is like telling your teen not to speed and then giving them a radar detector. HPV vaccination is like telling your teen not to speed, while reminding them to wear their seat belt. You want them to have protection from harm if they are in an accident – whether their fault or not.

and for the Christian philosophical basis for the vaccine:

As Jesus taught us in the story of the woman caught in adultery, Scripture teaches that we can/should show compassion by protecting others from the consequences of sin (while not endorsing sin or promoting continued sin). Facing death by stoning, Jesus protected her and offered forgiveness before calling her to a path of righteousness. He showed grace and compassion, not requiring her to commit to some standard prior to offering protection.

The American Academy of Family Physicians' (AAFP) email contained concerns about the ability to fund the vaccine and to obtain enough vaccine to administer it to all the eligible girls. The AAFP already had a provisional statement, but the move in several states, including Texas, to make the vaccine mandatory prompted the following:

"The AAFP feels it is premature to consider school entry mandates for HPV vaccine until such time as the long term safety with widespread use, stability of supply, and economic issues have been clarified."

Recently, there has been increasing state level action considering mandating HPV vaccination with proof of vaccination required for school attendance among other mandates. Upon review of the situation, the Commission on Science felt that this usage does not fit the classic public health model for infectious diseases such as measles. Several issues arise when considering a mandated school entry requirement. These include:



HPV does not adhere to the public health model for control of infectious disease in a school setting. (e.g. measles, chicken pox)

Universal school entry requirement would come at a cost of approximately $900 million per year to provide coverage for the female birth cohort (2 million girls: $120 per dose plus $25 administration fee; 3 doses). This would be a significant burden on state public health budgets.

There would have to be an assurance of supply of 6 million HPV doses per year to meet the school entry cohort. Given the recent experience with shortages of new vaccines such as the MCV4 for meningitis and Thimerosal-free influenza vaccine for three year olds, it is not clear that this new vaccine could be produced in adequate amounts to meet such demand at this time.

As with the costs for public health departments, there is concern that physician practices may not be able to afford such a large scale requirement at this time.

The Texas Medical Association leaders gave interviews to reporters concerning their reaction to the Governor's Executive order.

"We support physicians being able to provide the vaccine, but we don't support a state mandate at this time," said Dr. Bill Hinchey, a San Antonio pathologist and president-elect of the TMA, which represents 41,000 physicians. "There are issues, such as liability and cost, that need to be vetted first."

Other reasons cited by doctors in Texas and across the country include the vaccine's newness; supply and distribution considerations; the possibility opposition could snowball and lead to a reduction in other immunizations; the possibility it could lull women into not going for still-necessary cervical cancer screenings; gender-equity issues; and the tradition of vaccines starting as voluntary and becoming mandatory after a need is demonstrated.

Hinchey said that TMA leadership expressed their concerns to Perry on Tuesday. He said the TMA arrived at its position after debating the issue in committees in recent days.

A spokeswoman for Perry reiterated Tuesday that the governor stands by the order. She said he is listening to the discussion but thinks the vaccine is safe and effective.

Texas Governor pulls a fast one (HPV shot)

In all the excitement about Texas becoming the first State to mandate the vaccination against a Sexually Transmitted Disesase, no one seems to have noticed that Governor Rick Perry ordered the Health Department to make it easier on parents who wish to opt out on vaccinations for their children.

Parents' Rights. The Department of State Health Services will, in order to protect the right of parents to be the final authority on their children's health care, modify the current process in order to allow parents to submit a request for a conscientious objection affidavit form via the Internet while maintaining privacy safeguards under current law.

The current relevant law is all over the website containing Texas Statutes. I'm not at all sure that I tracked it all down, but most of it is in The Education Code, especially Chapter 38 and some is in the Health and Safety Code. The "opt out" provision is in 38.001, which was passed in 2003. I believe that this law was the first time in Texas that there was a formal way for parents to object for philosophical reasons, without having to claim health risks.


However, the law concerning the paperwork is in 161.0041 of the Health and Safety Code, and has higher requirements than the parental consent for abortion rulings!

Sec.A161.0041. IMMUNIZATION EXEMPTION AFFIDAVIT FORM.
a) A person claiming an exemption from a required immunization based on reasons of conscience, including a religious belief, under Section 161.004 of this code, Section 38.001 or 51.933, Education Code, or Section 42.043, Human Resources Code, must complete an affidavit on a form provided by the department stating the reason for the exemption.
(b)The affidavit must be signed by the person claiming the exemption or, if the person is a minor, the person ’s parent, managing conservator, or guardian, and the affidavit must be notarized.
(c)A person claiming an exemption from a required immunization under this section may only obtain the affidavit form by submitting a written request for the affidavit form to the department.
(d)The department shall develop a blank affidavit form that contains a seal or other security device to prevent reproduction of
the form. The affidavit form shall contain a statement indicating that the person or, if a minor, the person ’s parent, managing conservator, or guardian understands the benefits and risks of immunizations and the benefits and risks of not being immunized.
(e)The department shall maintain a record of the total number of affidavit forms sent out each year and shall report that information to the legislature each year. The department may not maintain a record of the names of individuals who request an affidavit under this section.

Added by Acts 2003, 78th Leg., ch. 198, Sec. 2.163, eff. Sept. 1,
2003.

In order to opt-out, the parent has to send a "written request" for the paperwork to the Department. The law actually states that the legal affadavit has to have "a seal or other security device" to prevent copying. Can this be done online?

Texas: First to Mandate STD Vaccine

That'll shock 'em on the coasts, won't it? Not to mention France and England, since the story has gone global.

Governor Rick Perry reportedly (free registration required) has signed an order mandating that teen girls in the State of Texas receive the vaccine against four strains of the Human Papilloma Virus by 12 years old and that the State pay for the vaccines that are not covered by health insurance. Two of these strains cause most cases of cervical cancer, and the other two cause most of the big, ugly genital warts that, while they don't cause cancer, can obstruct the urine or bowels and definitely cause bleeding and pain.

We all hope that our daughters and sons will meet their perfect mate, get married while they are both virgins. Then, we wouldn't have to worry about 99.7% of all cervical cancer. However, as Dr. Gene Rudd of the Christian and Dental Medical Association has said, no matter how well we raise our daughters and sons, their future husbands and wives may not have benefitted from the same background. A virginal wife can catch the virus from her husband on their wedding night(and vice versa - although he has vastly less risk of cancer of the penis in the US).

Another shock will probably come when (what the Houston Chronicle and the Austin American Statesman are calling) "the Governor's base" does not rise up in revolt and rants.

There is a strong lobby in the State against mandated vaccines (largely driven by objection to mercury preservatives, the vaccinations that are grown in human cell cultures and the troubles with the pertussis [whooping cough] vaccine from the '70's and '80's.) However, while good people who probably agree with the Governor's pro-life, pro-family views on other issues, these are not quite large enough to be called the Governor's "base."

In my opinion, the Governor decided that the vaccine is too important to leave to politics - especially in a State still healing from the redistricting fight of 2003, that ended up with first the Democratic Representatives and then the Democratic Senators running away from Austin and leaving the State to stall legislation.

I wish he would go ahead and let both the boys and girls get the shot -- Take a look at this video on "herd immunity." If we're going to do this thing, we might as well eradicate as much of the virus as possible.

I am concerned that no one knows how long the vaccine's effects will last.

On the other hand, this is Texas.

We don't like the government mandating anything. We can be convinced that some things are for the good - at least for other people - if you sell it right(grin).

The Governor must make a huge effort to convince the parents of Texas that this is good for the boys and girls in Texas, and that the money spent on the vaccine ($360 per girl, for 3 shots over 6 months) will save lives and money by preventing cervical cancer, genital warts and even anal cancer in both men and women.

Texas, Adult Stem Cells, Multiple Sclerosis

Opexa is a division of Pharmafronteirs (or it's the other way around, I'm not sure) which is based at the Woodlands, near Houston, Texas.

The company specializes in cell therapies, based on adult stem cells and the controlled manipulation and replication of adult cells.

Multiple sclerosis (MS)is a disease that causes the loss of the myelin around nerves. Think of myelin as insulation that speeds the transmission of nerve signals. When myelin is lost, nerve signals can't go where they're needed, as fast as they are needed. People end up weak, with tremors, and the lack of balance, loss of coordination and the loss of the ability for the muscles that enable us to breathe and cough to function.

We know that MS is a sort of autoimmune disease in most cases. The cells that are supposed to fight infection and keep abnormal or injured cells that can cause cancer actually decide that the myelin needs to be destroyed.

For over 4 years, Pharmafrontiers or Opexa has been running a series of experiments using T cells - the specialized white blood cells that mature in the Thymus and which are supposed to kill foreign cells, like bacteria or cancer cells.

The company has a technique for isolating the patient's specific T cells that attack their myelin, growing them in the lab until they have millions, and then treating them so they can't multiply. The treated cells are then injected under the skin of the patient, and the body really notices the cells, and uses all the immune system to attack them - and all or most of the T cells in the body that act like them. So the myelin is not destroyed anymore - or at least not as fast.


Opexa are now in Phase IIb - meaning that they know it's safe to use in people (Phase I tests) and are finding out more about how much is needed and who can be helped.

There's a great first-person story about someone who is being treated as part of the experiment at "I Have MS."

For a couple of very pretty videos that explain all this much better than I ever could - and the press release by the company about the Phase IIb trial -- take a look at the Opexa site, at this page.

Added:

Opexa is selling the treatment as "Tovaxin™" - a vaccine.

That's how vaccinations work, by the way. Our bodies are convinced to make antibodies and specialized white blood cells to kill or destroy the foreign bacteria, virus -- and someday, cancer and all sorts of cells that inappropriately make those antibodies and attacks against our own normal cells, treating them as though they are damaged or foreign. As long as our bone marrow is healthy, we seem to be able to make a nearly unlimited number of those white blood cells (there's also some "depots" or reserves out in the lymph nodes and in the liver, spleen and the gut lining where the cells lurk and wait for their chance to multiply and fight disease, evidently). And I think this is how "allergy shots" work.

Follow the DNA trail - "superbugs"

Google News search alerts sent me to Weazlesrevenge blog, and an article originally published in (of all places) WIRED magazine about resistant strains of Acinetobacter baumannii that - it turns out - moved from European hospitals back to the war zone in Iraq.

Since biochemistry in college, I've never been able to figure out why E. coli hasn't wiped us all out. E. coli, the bacteria that normally makes up the bulk of the intestinal contents and which causes disease when people are exposed to a new strain, is able to exchange genetic information with other bacteria in just about every way possible. E. coli is the reason you're told "don't drink the water" in some countries and remember the spinach?

It appears that one of the strains of Acinetobacter that has been a deadly problem for our soldiers injured in Iraq (reported by Forbes magazine in 2005) is another adaptable bacteria:

When a team of geneticists unlocked the secret of the bug's rapid evolution in 2005, they found that one strain of multidrug-resistant Acinetobacter baumannii carries the largest collection of genetic upgrades ever discovered in a single organism. Out of its 52 genes dedicated to defeating antibiotics, radiation, and other weapons of mass bacterial destruction, nearly all have been bootlegged from other bad bugs like Salmonella, Pseudomonas, and Escherichia coli.

At first, it was assumed that the bacteria came from the dirt and dust in the field in Iraq, resulting in contamination of war-zone hospitals and moving on to the secondary evacuation hospitals and eventually back to the US. Instead, DNA infectious disease detectives discovered that the germ originated in Europe and moved to the Iraqi hospitals by hitchhiking on medical personnel and equipment.


Little packets of circular DNA called "plasmids," protected packets called "phages," and even loose DNA in the environment, allow the exchange of information between one individual bacterium and another. Here and here are sites that explain the processes in more detail. And it may have you looking at that raw fruit or vegetable or the funny spot on the bread a little differently.

Never fear, the WIRED author tied the bacterial infection in with high tech informational nature of the magazine. I appreciate the twist on words:

In the open source world of bacteria, everyone is working for the resistance. Ramping up the immunity of any single organism, while dramatically increasing the size of the population most susceptible to infection, only helps the enemy. To an aspiring superbug, war is anything but hell.