Hip Replacement Alternative

By Amy Price PhD
My husband underwent adult stem cell therapy in hopes of staving off hip replacement. The technique in the USA was in the early stages and his hip degeneration was acute. In the end he underwent bilateral hip resurfacing in the UK. The procedure was successful and gave him his life back. The UK surgeons were most interested in stem cell therapy and they were working on getting stem cells federally funded particularly for revision surgery which happens when the artificial hip wears out after about fifteen years.

It was exciting to learn about six hip patients who underwent a very creative stem cell procedure in Spire Hospital, Southhampton UK. This procedure could prevent thousands of people from needing to have an artificial hip fitted.

Here is a short breakdown on how they are doing this. Surgeons are using the patient’s own stem cells to rejuvenate the affected bone and donor bone to speed the process. The stem cells are extracted from the patient’s pelvis, purified and cultured in an organic mixture that promotes growth. When the cells had multiplied they were mixed with cleaned, ground-up hip bone from other patients who had hips replaced.Surgeon then excised dead tissue from the ball of the hip and filled the cavity with the mixture of stem cells and donated bone.

Professor Richard Oreffo of Southampton University explains that stem cells send out chemical signals to attract blood vessels. "Bone is a living vibrant tissue. These stem cells generate new tissue and drive new blood vessel formation to bring in nutrients," he said.

Dr Dunlop is hopeful that this therapy will fix the hip for life. Early reports look promising with good results in 5 out of 6 study participants. The television footage on this was stunning. One patient who had his procedure a year ago looked like he had never experienced a hip problem.
Scientists and doctors are working together to expand this study and to explore the viability of using artificial bone. This would eliminate the problem of donor generated deficits being passed on although I suspect those already in need of new body parts are happy to take their chances.

This news is hot on the heels of research by scientists in New Jersey USA who have successfully isolated nerve growth factors in mesynchemal stem cells and grown them out as published in the latest issue of the Journal of Neurochemisty. Cell biology and Genetic engineering advances may soon provide real answers for those with untreatable neurodegenerative conditions and even those who have sustained brain injury.
Scientist and doctor teams are now considering how this therapy could be applied to other degenerative conditions.

Predictive Medicine

By Amy Price PhD

Predictive medicine can change our tomorrows today. Regenerative medicine can replace artificial body parts with lab grown technologies while genetic breakthroughs can save families from generations of genetic disability. It is possible that new knowledge of human genetics and cell biology is likely to transform medical practice. Three likely scenarios could evolve:

•Genetics will lead to the classification of diseases on the basis of the underlying genetics or biochemistry, rather than by symptoms alone leading to preventive rather than crisis orientated treatments.
•Genetic information will identify people who are likely to respond to drugs, or to be harmed by them (pharmacogenetics). This is already possible with certain psychotropic drugs on an experimental level but has not trickled down into mainstream medicine.
•Genetic variation will be a new ‘susceptibility factor’, permitting monitoring and early treatment or, perhaps prevention, of an increasing proportion of common, multifactorial diseases, such as coronary heart disease, hypertension, stroke, cancer, diabetes and Alzheimer's disease. Even stress management can be amplified with knowledge of individual genotypes

It is the genetic variation susceptibility factor which is considered to be the change maker for the advent of predictive medicine. This could lead to regenerative medicine on a cellular (somatic) level or even in vitro gene manipulation (germ line therapy) which could prevent intergenerational transfer of genetic disabilities.
Predictive medicine, when it comes, will be based on a much wider use of genetic testing, at present the gap between what the healthcare system is geared up and trained to deliver and what is scientifically viable is huge. For example there are treatments approved for traumatic brain injury that are effective but most be given within a couple of hours of trauma. This can’t happen now because emergency room personnel are not adequately trained or equipped to diagnose MTBI... As with any new technology applied to health in the context of a complex delivery system, implementation is not going to be simple.

First, of course, there needs to be demand from medical personnel and the general public. Typically wide spread change will only take place after the following criteria are established:

•Demonstration of clinical effectiveness and patient safety – through statistically valid clinical trials
•Cost-effective for general use – through economic analysis of trials and other data;
•Standardization of technology, and quality control – generally through outside regulation of suppliers and laboratories;
•Allocation of resources;
•Recruitment and education and training (or retraining) for health workers – including specialists, MDs, nurses, counselors and technicians. For instance a surgeon who makes a good living performing spinal fusions and cervical repairs will need significant convincing, retraining and motivation to become an early adopter of treatment that makes the previous way of doing business obsolete.

Predictive, regenerative medicine may be the wave of the future. History teaches us that the way to greatness is to find a way to serve many. My dream is to witness a generation of scientists and medical professionals join in unity with a foundation of integrity to build a tomorrow for the patients and public who have make their careers possible.

References:

Materials adapted from Open University Course Materials (accessed july,2009)

Instant stem cells...Freeze Dried Anyone?

By Amy Price PhD

I recently shared some posts on umbilical cord banking information. Dr Fran Verter of the Parent’s Guide to Cord Blood Foundation shared with us how this works. It seems storage and transport can introduce complications so I wondered what would happen if we eliminated those high tech freezers and freeze dried the stem cells instead. Could they be reconstituted and retain the integrity needed to reproduce?

I located a journal article on Plos One along with others who are using these techniques. Apparently the first generation reproduced DNA accurately which is no surprise as this is a forensics basics but the other portions of the cell needed for healthy growth didn't survive. They are now getting success rates in the 90% range for cells they have reconstituted and then reproduced. The University of Rochester, Image above, is showing some interesting research on using freeze dried cells for bone repair and tissue engineering

This solves a lot of storage problems, should reduce costs and cells could last for years. The ones used in the studies were three years old and over. It is anyone's guess how long this could take to become a viable option for human adult stemcell storage but what a great concept...Stemcells To Go

Diabetes Type 1 and 2 Adult Stemcell Trials Underway

By Amy Price PhD

The Journal of the American Medical Association, reported on a study of young adults with newly diagnosed diabetes. These young people were treated with their own stem cells. 20 out of 23 reduced or ended dependence on insulin as their bodies took over production of insulin. Twelve patients stayed off insulin for extended periods, while eight relapsed and returned to low-dose shots. Three didn’t respond. The average time individuals avoided insulin shots was 31 months

The concept driving the research is as follows. In type I diabetes, the patient’s immune system turns on the beta cells that produce insulin, the hormone that breaks down the glucose we eat in food. Eventually, the immune cells will virtually eliminate all of the body's beta cells, and glucose levels will start to climb. Researchers considered if they wiped out the original immune system and replaced it with stem cells it could reset the person’s immune system with disease free cells.
Patients are fist treated with chemotherapy to reduce overactive immune system. Stem cells extracted from the patient’s own blood are grown out and later returned through intravenous injection. This procedure is carried out within six weeks of initial diagnosis for best chance of recovery.

The procedure is certainly not risk free as complications of the stem-cell treatment included pneumonia in two patients, low sperm counts in nine of the 17 men in the study, and endocrine dysfunction in three patients.

Levels of C Peptide were measured as this substance shows up when cells are making insulin. 20 out of 23 participants showed improved insulin production.

Julio Voltarelli, and colleagues at the University of Sao Paulo, Brazil, with colleagues in the U.S. worked on this project. Voltarelli's team has managed to show that the stem cells can give long-lasting beta cells a chance to grow — at least ones that can produce insulin for about three years. Other researchers are pursuing intriguing new stem cell options, including stem cells that can be grown from a patient's own skin, which would eliminate the need for extracting immune stem cells from bone marrow.

No one considers this a cure yet but it is a step in the right direction “A cure is needed, but it will probably not come from a single breakthrough,” wrote Christopher D. Saudek of Johns Hopkins University in Baltimore, in an accompanying editorial. "I wouldn't use the word cure," says Dr. Richard Burt, one of the co-authors from Northwestern University. "But it appears we changed the natural history of the disease. It's the first therapy for patients that leaves them treatment-free — no insulin, no immune suppression for almost five years."
"Every door that we open leads to another door," says Burt. "All research is built by sitting on the shoulders of other studies. This trial is something that will contribute to and move the field of stem cell therapy forward." It is, as Burt says, a start. For a Julio Voltarelli and colleague webcast click here

A study using donor adult bone marrow stem cells has garnered FDA approval with a company called Osiris Approximately 60 patients will be enrolled in this trial. Male and female patients are eligible and must be between the ages of 18 and 30 years old. Patients must have been diagnosed with T1DM based on the ADA criteria and must be screened for clinical trial eligibility between 2 and 16 weeks from initial T1DM diagnosis.

If you or someone you know has recently been diagnosed with T1DM and you would like more information, please contact us at Diabetes@Osiris.com.

There is also a study underway as of March for type 2 Diabetes. The university of Miami in conjunction with other sites are starting clinical trials combining adult stem cell therapy with hyperbaric oxygen as this combination was quite promising in an initial pilot study. As of January 2009 Researchers were planning to recruit patients between the ages of 45 and 65 who have been diagnosed with type 2 diabetes after age 40 and have had the disease for more than five but less than 15 years. The media contact for this research is below. You can read more at http://www.diabetesresearch.org/Newsroom/NewsReleases/DRI/oxygenstemcells.htm
Media Contact:
Jeanne Krull
University of Miami Miller School of Medicine
305-243-4853 / 305-812-6668
jkrull@med.miami.edu

The image is borrowed from a blog with a really concise nicely done diabetes information site http://kirstyne.wordpress.com/2007/09/03/another-reason-to-keep-your-weight-in-check-diabetes/
More information can be found at http://www.diabetes.org/

Two Hearts, The FDA and Stem cells

By Amy Price PhD
My email informs me people are hungry for real help on finding medical providers who can offer stem cells. They want to know are stem cells a viable alternative, Can you find me quality information instead of hype, and what is your view on the FDA in this regard?

This field is moving very rapidly and what was not possible only a year ago is happeneing today.I have sen great and not so great results for orthopedic, heart, blood and some wound healing applications but it is important to realize that this therapy is still in experimental stages and there are no guarantees.

A few pioneers have moved through the opposition and fear of new therapies to pave the way for university hospitals who are now offering up stem cells in the way of research. One good example is new heart tissue grown out in Los Angeles "We seek to actually reverse the injury that has been caused by the heart attack, by re-growing new heart muscle to at least partially replace the scar that's formed," says Dr. Eduardo Marban of Cedars-Sinai Heart Institute

Watch CBS Videos Online
A tale of two hearts summarizes this nicely. Both hearts were damaged. The first heart was in a young man whose parents are dedicated medical professionals. They waited eagerly for FDA clearance so they could take their son for a legal stem cell repair. The wait was too long and emergency surgery ensued. The young man lived but sustained brain damage and paralysis. This heart could have been repaired with adult stem cells. A company that developed the stem cell technology was less than one hour from them. The cultural mindset opinion that procedures performed outside of North America because of FDA restrictions were too risky cost them deeply.

On the other spectrum was a banker friend well known in the diplomatic community? His heart was damaged and he was urged to change his lifestyle and lose weight. He picked up over the counter diet pills later banned by the FDA and marched to the treadmill like a soldier in boot camp to the acclaim of family and treating professionals. Noticing his lips and finger tips had an ominous bluish tinge, I asked to see the pills. They contained amphetamines in the form of herbs. We urged him to see his cardiologist and to stop the pills but he chose to soldier on until a month later he collapsed on the treadmill and was taken to hospital where his chest was sawed open and major heart surgery took place as it was the only way to save his life.
The FDA found a niche because when humans are physically vulnerable they will pay or do almost anything for survival. They keep us safe from predators in the marketplace. They help us with food labels and medical warnings. Dieters have been known to ingest tapeworms, destroy their stomachs, livers, kidneys, hearts and intestines to lose a few pounds. Doctors who see patients on whom they conduct treatment for a fee will say I have to be honest with you the chances aren’t great but if it is your choice we can proceed. They are applauded for their ‘honesty’ whether the treatment succeeds or not. We say go ahead because even false hope is better than none at all. Likely none of us would hire a roofer who said I will work on your roof but because of pre-existing structural damage it likely won’t work out! The FDA has a tough job and emotional stakes run high.

On the other hand the FDA is a bureaucracy with allegiances and political agendas, not because they are necessarily evil but because this is a given for group behavior. They are shaped by society and moved by mass public opinion. They also make mistakes and if some of the lifesaving drugs we have today would have needed FDA approval masses would be dying while wars were fought that have little to do with how well something works.

Do I think most people or their doctors have enough medical training to make an informed choice about stem cells? No…but I am not sure the FDA is in a position to make this choice for the best interests of the people and I would welcome some of the transparency they have promised.

Would I consider not having FDA approval for a therapy before using it on myself or family? I would not consider a banned or illegal substance but I would have non FDA sanctioned treatment or off label use of pharmaceuticals. It has in the past improved my quality and likely my length of life. I would not consider a choice like this lightly. The risks need to be weighed against the benefits and I would have to know and trust the doctor involved whether in this country or somewhere else on the globe.

Parkinson's Disease Stem Cell Sequel

By Amy Price PhD

I found an interesting addition to the Parkinson's post's in the form of an article from Nature. Many thanks from helpful individuals at the Open University in the UK for passing this on.

In the article in Nature Suchowersky O. Transplantation therapy for Parkinson disease: the good, the bad and the enigmatic. Nature clinical practice. Neurology. 2008 Sep;4(9):465
Parkinson disease (PD) affects an estimated 1 million cases in North America . Motor symptoms in PD initially
respond well to dopaminergic replacement medications, but because PD progresses the drugs gradually lose effectiveness after about 10 years resulting in gait dysfunction and complications such as dyskinesias
PD is not just a disorder of the dopaminergic system but involves other neurotransmitter systems which inform autonomic dysfunction, mood disorders, fatigue, pain, sleep disorders and cognitive function. Dopaminergic cell replacement, even if successful is thought capable of treating only motor symptoms.
Over 20 years ago, transplantation of fetal ventral mesencephalic cells into the putamen was
performed on a small sample of participants with reportedly good results. Regrettably further studies with larger participant pools failed to confirm the initial reports (Freed CR et al. [2001] N Engl
J Med 344: 710–719). PET and pathological analyses revealed adequate survival of grafted
neurons, and there was untreatable runaway dyskenesia. However clinical benefit was seen in
a small subset of patients, 16 years on autopsy results are available Mendez et al. showed survival of
grafts without PD pathology for 14 years in five patients (Mendez I et al. [2008] Nat Med14: 507–509). Another patient showed good clinical improvement l 5 years plus, before gradual worsening of motor function and development of gait and balance problems (Kordower JH et al. [2008] Nat Med 14: 504–506). Autopsy results from this patient 14 years after transplantation showed great graft survival but grafted neurons had pathological
changes typical of PD, including Lewy bodies and activated microglia (cell scavengers) were seen in large numbers
Liet al. reported similar graft pathology in three patients up to 16 years after transplantation (Li JY et al. [2008] Nat Med 14: 501–503). These results indicate that for stem cell therapy to be effectual long term in D research needs to be initiated to investigate the spread to youn grafted neurons and determine strategies to resolve this issue. I would hope that advancement in the area of Adult Stem Cell research will make this possible in the near future.

I am finding the stem cell story is not so new. I did hear about a very young women stricken with metasticized spinal cancer who was treated at Sloan Kettering with grown out adult stem cells taken from her own bone marrow over fifteen years ago. She is now a successful professional with no trace of malignancy in her body. I also remember twenty five years ago in Canada I knew three terminal patients who underwent adjustments to the bone marrow transplant protocol that involved growing out their own bone marrow cells. One person enjoyed a year free from blood cancer and then relapsed but the other two lived. It is strange that when I go to Pub Med , Google Scholar or even the University library there is no trace of this research performed for "humanitarian reasons"

There is also a lot of interest in the London Project where stem cell trials are close to human trials for those with macular degeneration. Pfizer is quoted as expected to announce backing of stem cell therapy, apparently with joint labs in Cambridge Mass and Cambridge UK but on the Pfizer site I didn't see this in place.

Individuals are reporting encouraging success for adult stem cell treatment where they are thier own donors particularly for orthopedic and cardiac applications. These treatments are largely privately funded. It would be great to see this in the mainstream covered by insurance and available for people regardless of income levels

Parkinson's Adult stem cell Breakthrough and more

More about Parkinson’s and stem cells….Keeping you posted as I learn too… The photo showing where damge occurs is from web MD (2002)

Would you be surprised that the technology to implant neural tissue in humans to alleviate Parkinson’s Disease was available as early as 2001 and in case studies has produced more successful remission than any drug on the market and with fewer side effects?

Michel F. Levesque, M.D., F.R.C.S.(C), F.A.C.S.Cedars-Sinai Medical Center in Los Angeles, Associate Clinical Professor of Neurosurgery at the UCLA School of Medicine, and member of the UCLA Brain Research Institute applied for Phase 11 FDA approval in several years ago. This was granted but sponsor complications and new rules by the FDA have put this phase on hold until Levesque and company can jump through the new hoops and negotiate more sponsors. This is tragic for Parkinson’s patients who could die or degenerate significantly before help is available.

It seems that the FDA would apply the same standard to our own cells that they do to foreign drugs. Pharmaceuticals take a ten year, 750,000 million dollar investment on average to bring to market and to start to make a profit. I do wonder about the stability of stem cell companies that have not counted the cost or prepared a strategy and stored up ammunition for battle. What did they think was going to happen? Nevertheless it makes one long for the days when scientists bit the bullet and practiced on themselves and family members. The results produced their own script. It seems today the trend is to scorn the establishment while begging to get into ‘the inner circle’. This cannot in all fairness be blamed on the FDA but rather on the inconsistencies of human nature and the need to belong. It is tragic that ethics and human decency for ‘the little people’ are tossed aside in the parade of blind ambition that ignores the simple concept that if you take away from the foundation (those that have supported your growth) the structure will destroy you…but I digress, on with the story….

It does seem strange that it is a woman’s ‘right’ to terminate a child but it is not an individual’s right to choose their own stem cells. The right to terminate brings death and is endorsed but the right to life through the harvesting of our own stem cells is denied by an outside source.

It is not like the FDA is even particularly good at culling out the problem children in the industry or adding to medical knowledge. A simple Google search on major drugs and problems in approved FDA pharmaceuticals is an eye opener in politics and commerce rather than the mainstream of patient safety for which they purport to represent.

Levesque and his colleagues did a successful case study with a man suffering from Parkinson’s in 2001 and yet in 2009 Parkinson’s patients are still dying needlessly. The FDA is still a bureaucracy which people are distracted into attacking while Scientists followed by the masses line up on the adult stem cell or embryonic bandwagon instead of putting partisan economics and politics aside to join together as scientists to promote healing and answers for those without hope.Here is a little about the study below:
“MATURE NEURONS DERIVED FROM THE PATIENT’S OWN BRAIN CAN BE TRANSPLANTED BACK SAFELY AND IMPROVE SYMPTOMSWe recently presented the clinical outcome of our autologous method at the International Congress of Parkinson’s disease and Movement Disorders in Rome. In accordance with our institutional review board, we transplanted a patient with advanced Parkinson’s disease with differentiated neurons derived from an initial needle biopsy. At three years post-operatively, the overall Unified Parkinson’s Disease Rating Scale (UPDRS) improved by 81% while “on” medication and 83% while “off” medication. We demonstrated here the long-term clinical remission of Parkinson’s disease symptoms in a single patient.Because of their biocompatibility, safety and potential integration into the host striatum, autologous adult neural stem cells and stem cell-derived neurons represent an effective alternative to current cell therapy aimed at the restoration of dopamine neuronal loss in Parkinson’s disease. Under the guidance and supervision of the Food and Drug Administration (FDA) office of Cellular, Tissues and Gene Therapies and the Center for Biologics Evaluation and Treatment (CBER) we are about to begin Phase II trials using this promising cell therapy.
CONCLUSION
Degenerative and traumatic disorders of the brain represent an enormous burden to the patient, their family and health care providers. The current debate between the embryonic stem cell proponents and those who are opposed to their use distracts from other avenues with promising outcome, such as adult stem cell therapy. It also overlooks other important issues of resource allocation between basic and clinical research, health insurance, and patient care. Scientific knowledge has rapidly progressed in the last five years (written in 2004) and stem cell research and therapy remains a very promising field for treatment of neurological disorders. In a recent biotechnology industry meeting, a presentation had the approximate title: “Businesses are from Mars, Academics are from Venus”. What was forgotten there is that patients are from planet Earth and this is what should guide our efforts “ (Levesque, 2004)For the complete story read here and for an update on where things are today check out this link

Love S et al., Glial cell line-derived neurotrophic factor induces neuronal sprouting in human brain, Nature
Medicine 11, 703-704, July 2005
Slevin JT et al., Improvement of bilateral motor functions in patients with Parkinson disease through the unilateral intraputaminal infusion of glial cell line-derived neurotrophic factor, Journal of
Neurosurgery 102, 216-222, February 2005
Gill SS et al.; “Direct brain infusion of glial cell line-derived neurotrophic factor in Parkinson disease”;
Nature Medicine 9, 589-595; May 2003 (published online 31 March 2003)