Cerebral Palsy: Cord Blood Stem Cell Research and Treatment in Clinical Trials – Update

For those of  you who follow our blogs, you know well that this is a topic of interest for us.  It bears repeating – our job as lawyers is to properly investigate potential claims of malpractice in areas such as cerebral palsy and seek redress for our clients when the evidence demonstrates a connection between birth injuries and medical care, but the much more important topic for our clients and victims of cerebral palsy is in the field of medical research. It is through research efforts – including clinical trials – that this dreaded condition will be ameliorated and hopefully eradicated. Trust me, after practicing law for over 35 years, I’m not worried about job security – the frailties of the human condition will more than suffice to fill our file cabinets with people to help due to the negligence of others.

We have reported previously on various topics involving cord blood and stem cell research as they relate to a number of conditions, including cerebral palsy.  It seems that months have passed since there has been any significant news about two programs underway: one at the Medical College of Georgia and the other at Duke.  Earlier this month, an update came across the social media network via a post by Singularity Hub – Cord Blood Stem Cell Treatment for Cerebral Palsy in Clinical Trial | Singularity Hub.

Here’s our encapsulated version regarding the studies and Singularity Hub’s report.

Photo provided by MSNBC

Duke University

According to the website ClincalTrials.gov, Duke began a clinical therapeutic trial – identifier: NCT00593242 – in January 2008 (estimated completion date of January 2011) whose primary purpose is listed as treatment of newborns with hypoxic ischemic encephalopathy (HIE) – inadequate oxygenation in the perinatal period for purposes of this study – through the controlled “collection, preparation and infusion of a baby’s own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.” For information concerning the inclusion and exclusion criteria for participation in this clinical trial, see the online posting. Essentially, the babies are then to be “followed for neurodevelopmental outcome at 4 – 6 and 9 – 12 months at Duke’s Special Infant Care Clinic. MRI’s will be obtained between postnatal weeks 1 and 4, and, for study purposes at 4 – 6 postnatal months.”

While other aspects of processing and administration are no doubt part of the key components of this project, it is readily apparent that the end-point goal is discovery of an effective treatment of cerebral palsy for the identified neonates in the study and then development of a second stage clinical trial to take such treatment modality to a greater number of potential beneficiaries.

Medical College of Georgia

For detailed information on this study, which began in February of this year, similar information is available through ClinicalTrials.gov under identifier NCT01072370.  This clinical trial investigation has a patient population consisting of children from ages of 2 to 12, “whose parents have saved their infant’s cord blood, who have non-progressive motor disability, and whose parents intend to have a cord blood infusion.”  Again – for full details regarding inclusion and exclusion criteria, see the full online posting.

For those parents who may be interested in determining if their child would qualify to participate, the study is still recruiting participants.  The contact information is also available at this link: Contact: James E Carroll, M.D.     706-721-3371     jcarroll@mcg.edu

Today’s report from Singularity Hub provides some encouraging – albeit anecdotal – news of potential progress.

The anecdotal evidence in support of treating cerebral palsy with cord blood stem cells is astounding. Much of it has actually been been performed at Duke University by one of the investigators in the pilot study: Joanne Kurtzberg. Among those that have been successfully treated at Duke include Ryan Schneider, Maia Friedlander, Chloe Levine, and Dallas Hextell. All had CP or CP-like symptoms and all made remarkable recoveries after cord blood stem cell treatments. Dallas Hextell, who showed improvements just 5 days after his therapy was featured on the Today show (the original report contains video compliments of MSNBC).

In addition to the early good news coming out of these projects, one other lesson is learned – for the time being, the storage of cord blood is an important component for those hoping to participate in such studies – particularly that being conducted at the Medical College of Georgia.  We have earlier reported on this topic as well.  You may want to refer to our early posting for some basic information if you are interested.

Obviously, the implications – if these projects prove to be successful – are far-reaching. The enthusiasm of the participants in these research projects is not limited to them alone. The words of the author, Aaron Saenz, from Singularity Hub somewhat tells it all:

So we have some exciting news for cerebral palsy, and some exciting news for those thinking about cord blood. What about the rest of us? Well the MCG and Duke work has some far reaching implications. Neurological damage, whether it’s caused by oxygen deprivation or some other injury, is one of the most difficult things to heal in the body. Work in animals (like that done by Carroll on rats) show that stem cells can not only help damaged brain cells recover, but they can also replace cells that have died. We may find that stem cells therapies have a wide range of applications for many different forms of brain damage. Kurtzberg is researching many different ways cord blood could be used (autologous or through donors) to treat a variety of conditions. In other words, today stem cells conquer cerebral palsy…tomorrow, the world.

Let’s all hope that Mr. Saenz is a prophet.

Research – Stem Cells: Adult Stem Cells Producing As Much Excitement in Research Community as Embryonic Cells

We continue to report on stem cell research since it is clear that the joy and exuberance of researchers may one day (hopefully not too far away) translate into cure and joy for many afflicted with and suffering from  a variety of diseases.  While our earlier reports have somewhat centered on stem cell research in the field of cerebral palsy, rep0rts continue to surface as to a variety of other positive advances relating to adult disorders.  

As a side note – you may wonder why a law firm, whose task it is to represent those injured by the negligence of others, would have any interest in positive medical news.  The answer is quite simple – having had the privilege of representing injured clients and making their lives a bit better monetarily, lawyers are always limited in just how much they can do to improve the quality of life for their clients. It is the medical community that will ultimately make the difference in alleviating if not curing these life-altering disabilities.  Therefore, we at Nash & Associates have  decided that in our blog, we will not only report on strictly legal issues (verdicts, key appellate decisions, changes in the law, etc.), but also on key medical news  (the good, the bad and the ugly) including significant medical advances. Contrary to what many cynics say about the legal profession – it is not all about the money.

This point in history marks a period of approximately one year since President Obama removed limitations on research into embryonic stem cells.  While significant amounts of research money was to be devoted toward this research, the financial crisis has no doubt had an impact on freeing up this financial commitment.  What is of significance, however, is that the answers to many advances in treatment options using stem cells may lie in non-embryonic stem cells. A recent posting in Top News suggests that the excitement in the research community is in large part based on their recent discovery that adult stem cells taken from a patient’s bone marrow or belly fat may yield positive results equaling those of embryonic stem cells.

Dr. Joshua Hare, Director of the Interdisciplinary Stem Cell Institute at the University Of Miami Medical School stated that adult stem cells are more flexible than they had thought. The embryonic stem cell may not be the one that proves to be really successful in the actual therapy.

His institution has already been injecting the area around a patient’s heart so as to help heal the tissue injured in a heart attack.  It is also noteworthy that adult cells are also being used in research programs to bring about improvement in functioning of patients with  injured spinal cords.

For those of you interested in advances in stem cell research, there are many excellent blogs and reports appearing on almost a monthly, if not weekly basis. You may want to check out The Stem Cell, The Stem Cell Blog and a new friend of ours on Twitter – cellresearch. There is also a very helpful and informative site created by the National Institute of Health, which provides a very good basic understanding for the public of what stem cells are, the government’s policy on stem cell research, current research projects and the like.

Children With Cerebral Palsy May Benefit From Cell Transplants

Since our firm at any given time handles a number of cases involving cerebral palsy, I am constantly trying to find useful information about new developments in therapy, research, procedures – anything relevant to the topic of preventing or helping those who suffer from cerebral palsy.

This morning I came across a report in Medical News Today –Children With Cerebral Palsy May Benefit From Cell Transplants – which, I must admit, I had not heard of before.  Apparently a group of Chinese researchers are now hypothesizing that a type of cell known as olfactory ensheathing cells (OECs) may hold promise for treatment of infants and those in early childhood with cerebral palsy.  

Clearly this research by the Chinese is not yet being conducted on a large scale level. Nevertheless, I thought I would report on this since the ‘science’ (in which I don’t purport to have expertise) seems logical and potentially noteworthy. With those qualifiers in mind, here is what’s behind this ‘thinking.’  Rather than try to give you the layman’s recap of OEC’s, I’ll let the article speak for itself.

Transplanted OECs, known to retain exceptional plasticity and promote olfactory blood vessel growth while offering neuroprotection, have been demonstrated to be potentially useful for a number of neurological disorders, including multiple sclerosis, spinal cord injury and amyotrophc lateral sclerosis (ALS).

So what does this mean for those who suffer from cerebral palsy? The corresponding author Dr. Hongyun Huang of the Beijing Rehabilitation Center provides the details:  “We conducted a randomized, controlled clinical trial with 33 volunteers, 14 of whom completed the six-month study, to determine if transplanted OECs were effective in treating children and adolescents with CP, given that CP shares many of the same features of other degenerative diseases.”

According to Dr. Huang, a protocol was developed from this hypothesis based on their knowledge of a key location “in the brain’s frontal lobes (defined as the “Key Point for Neural network Restoration (KPNNR)” based on previous studies) for injecting OECs and that the injected OECs would produce Schwann cell-like myelin sheaths around demyelinated axons.”  Demylinated axons are often referenced as a rather consistent finding when imaging the brains of victims of cerebral palsy.

Buoyed by the findings of this admittedly small trial group, Dr. Huang reports:

“Our results showed that transplanting OECs into CP patients could improve the neurological function of the patients and did not cause significant side effects. The procedure may be a plausible method to treat this as yet incurable disorder.”

For anyone who saw the recent 60 Minutes report (21st Century Snake Oil) on charlatans advocating a cure through injection of stem cells (for virtually any malady under the sun), caution takes center stage with all such reports.  No – I’m not suggesting that the Chinese study is voodoo medicine by any stretch of the imagination.  For those who keep up with this field of stem cell research and its potential applicability to treatment of cerebral palsy, you are aware of the recent (early February of this year) announcement by the FDA of an approved trial for stem cell research for victims of cerebral palsy. In addition to our having reported on this FDA-approved trial, I have also reported on a collaborative research program called Newborn Possibilities Program in Arizona, which is yet another collaborative effort using stem cell research concepts to improve the lives of these children.

While hope reigns eternal that meaningful research will lead to meaningful cure or improvement in the quality of life for cerebral palsy victims, Cell Transplantation associate editor Dr. Cesar V. Borlongan offers the following words of caution concerning the Chinese (and other) stem cell clinical trial:

In parallel with recently FDA-approved US clinical trials of cell therapy for adult stroke and cerebral palsy, this clinical study in China advances the use of stem cells for treating brain disorders, but a very careful assessment of this experimental treatment needs to be exercised in order to gauge its safety and efficacy.

Through social networking media such as LinkedIn and Twitter, I have come across some fascinating people who have devoted their lives to stem cell research.  If perchance any of my ‘connections’ and ‘followers’ out there have further information about this Chinese research and other stem cell research programs involving cerebral palsy, I would greatly appreciate your sharing your information with the Nash Law Firm community of readers by posting helpful comments to this blog.

Obstetricians’ Opinions Divided Over Umbilical Cord Blood Banking: Some Doctors Refuse to Cooperate

Earlier this week, ABC Australia posted a fascinating report on a modern practice by parents paying significant sums of money to store  (or bank) their baby’s umbilical cord blood.  While cord blood has been used widely by patients (not related to the donor) in other medical settings such as bone marrow transplants, this new practice is designed to help the donor babies later in life for treatment of conditions that they hope science will discover meaningful solutions for in the coming years.  According to the report, “The hope is that the young, versatile stem and immune cells in the blood could eventually be used to repair damage caused by anything from cystic fibrosis to a heart attack with no risk of rejection.”

What is occurring, however, is that not all physicians are accepting of this concept.

The subject of this news story, a West Australian mother, Barbara Ayling, has cerebral palsy.  This is one of the conditions that parents and researchers are hoping will prove to be treatable through stem cell research using umbilical cord blood.  Ms. Ayling and her husband had made arrangements to have their baby’s cord blood stored through the age of majority.  The plan went awry when the obstetrician who agreed to participate in this collection and storage process was unavailable and the delivery was performed by a different doctor who refused to carry out the procedure.

“It’s a choice that I have the right to make. Apart from anything else, I’m spending a phenomenal amount of money to do this,” Ms Ayling said.

“I’ve made a very informed decision and I would have liked that to have been more respected.”

The doctor declined to be respond when asked to do so by the station.

Further details about this banking program were provided by an online video.  The reporter asks her audience the opening question: “How much would you be willing to pay to guarantee your child access to a yet unproven but potentially life-saving cure for potential disease?”  It turns out that at least in Australia, that price tag varies between $3,000 to $6,000.  Unfortunately for some, this ‘investment’ in their child’s future health went the way of many investments – it tanked when the company storing the blood went out of business.

It is clear that this practice is not restricted to Australia.  More to the point, there are a number of companies in the United States ostensibly offering parents the same banking of their child’s umbilical cord blood.  For instance, a company called Alpha Cord, which according to its website has been in business since 2002, promotes the fact that it is different from other cord blood banking operations in the United States since it provides parents with an additional layer of security for their investment.

In the unlikely event the bank you’ve chosen should dissolve, we will move your cord blood to another licensed and accredited facility in our system. If you bank directly, there is typically no automatic or seamless provision for an adverse event such as this. (Source Alpha Cord website’s FAQ’s)

Alpha Cord provides its site’s visitors with videos about the process, purpose and benefits of storing a baby’s umbilical cord blood cells.  The benefits range from future transfusion needs to potentially successfully treating later disease and/or injuries.  Alpha Cord advises that currently hundreds of thousands of parents have elected to store their baby’s cord blood.  In its comparative pricing chart, it compares its reduced price (ostensibly due to networking discounts) and parents are offered a geographical locator for participating banks and then an online calculator with options for how many years one may want to store their child’s cord blood.

60 Minutes Picture of Keone Penn cured by stem cell treatment

For example, if a parent were to store their child’s cord blood in Utah, the initial fee would be $775; whereas, storage in Chicago, New Jersey or Colorado would cost $1,395.  Annual storage fees for Alpha Cord are $115 with a 20 year storage plan amounting to $2,180.  If you would like to get a ‘comparative shopping list,’ Alpha Cord provides such a chart.

Given the unwillingness of the Australian mother’s obstetrician, parents planning to utilize this service might be well advised to confirm that their obstetrician and those who might be covering for him/her are on board with the collection process.  If  you have had experience with this or similar programs but have encountered resistance by your obstetrician or hospital, sharing your experiences might be of great value to others considering banking of their child’s cord blood.

Univ of Michigan’s Cancer Center Study Tests Freezing Technique for Breast Cancer Tumor | Testing It Up – Test Country Blog

Is there a new treatment for breast cancer on the horizon? Read this blog report –  Study Tests Freezing Technique for Breast Cancer Tumor | Testing It Up.

Cryoablation – freezing – has been successfully used in mice to stop the spread of breast cancer.  The research was conducted by a team at the University of Michigan Comprehensive Cancer Center, which is affiliated with the university’s medical school.

Dr. Michael Sabel, who led the team of researchers,  explained the following in a news release:

“Cryoablation has strong potential as a treatment for breast cancer… Not only does it appear effective in treating the primary tumor with little cosmetic concerns, but it also may stimulate an immune response capable of eradicating any cells that have traveled throughout the body, reducing both local and distant recurrence, similar to giving a breast cancer vaccine.”

The original report on this important research was done by BusinessWeek – for further information read the posting by that publication.

If you go to the Center’s site,  you will also find fascinating and important stem cell research being conducted by that institution and an informative video done by the Center’s director, Dr. Max Wicha, regarding their stem cell research efforts.

It was at this Center that breast cancer stem cells were first discovered in 2003.

While there has been a steady decline in the death rate related to breast cancer since 1990, the bad news is that approximately 41,000 women are still dying each year in the United States alone from this horrible disease.