Category Archives: Cell Therapy-Stem Cells/Oths

Cord Blood Stem Cell Treatment for Cerebral Palsy

Stem Cell treatment comes in many types.  Its been around now for several years.   When our daughter was born 11 years ago, we were just starting to hear about it.  In these last 11 years, clinics in places like China, Mexico, etc. have been offering stem cell treatments.  To our knowledge, no miracle cures have happened yet.   In fact, injecting anything into a child is dangerous business and some serious complications and even deaths have been reported.  China’s federal government has announced an official hold on stem cell treatments for cerebral palsy for fear of losing control over the many small clinics that have started to offer the treatment, however, my understanding is that the the network of Army hospitals operate independently and have continued to offer treatment.  Again, from what we have seen, there have been no miracle cures.

This brings us to the USA and two clinical trails being done on Cord Blood.  Here is a video that is quite interesting.

Cord Blood Stem Cell Treatment for Cerebral Palsy in Clinical Trial

The Medical College of Georgia and Dr. Joanne Kurtzberg at Duke University have begun FDA approved clinical trails using IV infusions of stem cells from a child’s own umbilical cord (autologous).

The Duke study is funded with a $10.2 million donation from the Robertson Foundation.

The mechanism that is at work is unclear, however Dr. Kurtzberg hypothesizes that cord blood cells can reduce inflammation in the brain, produce hormones to repair brain cells or possibly transform themselves into healthy brain cells to replace the damaged ones.

James Carroll, the head researcher for the clinical trials at MCG, has had success with treating oxygen related brain damage in animal tests. Rats with induced CP-like conditions were shown to have improved motor skills after multipotent adult progenitor stem cells were introduced.

In MCG’s trial, children 2 to 12 years old will be given IV infusions (half will receive cord blood stem cells, half placebo) and then examined three months later. At that point, the placeboed half of the patients will receive cord blood stem cells. Examinations will continue three and six months later.  The Duke study focuses on children 1 to 6 years old.

Outside of the trail, it is said Dr. Kurtzberg has already treated about 150 patients with positive results.   BRIGHT hopes to contact Dr. Kurtzberg or any of the parents who’s children have received these treatments.

Cerebral Palsy which affects 2-3 children per thousand in the US.  The Centers for Disease Control estimated in 2003 that the cost of caring for someone with CP over a lifetime is $921,000.

60 Minutes Investigation – Stem Cell Fraud

I would like to make a comment on this 60 minutes video. First off, I am a sucker for the underdog. Although I am not defending this man, I have to say the reporting and investigation is a bit dramatic and one sided.   Chris Arnold from the SCI forum comments “Could it be that the primary aim of this production was a good dollop of shock/horror that will guarantee good viewing numbers? “

Perhaps the real story that should have been investigated is why is it that so little progress has been made toward a Cure for Brain Injury?   Where is the money that is being invested into research actually going?   Is it being spent  efficiently?   Is there accountability?  But that would not make for very dramatic reporting…

Regarding the risk of Stem Cell treatment and other non-standard treatments.  Yes, they can have huge risks.   However, here is the issue. All of medicine is filled with risk. No doctor or no amount of clinical trials can tell you if a procedure is effective or risk free for you. The issue is that when it comes to humans, the sample size is ONE. There is only one you and when you take any drug, undergo any procedure, etc. How your body reacts is going to be unique. Yes, aspirin is safe for a large part of the population; however it kills thousands of people each year! Thousands!

The July 1998 issue of The American Journal of Medicine explains it as follows: “Conservative calculations estimate that approximately 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) complications and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone.”

With regard to Stem Cells, I think the ideal approach is to allow people to make their own informed choices. To assume that all people who chose to perform a risky procedure are “tricked” or “stupid” and therefore need to be told what procedures can and can’t be used by government is utterly wrong.

Doctors routinely prescribe off-label medications. Some estimates say it accounts for 50 percent of all drug use in the USA. Getting back to the 60 minutes interrogation question “if stems cells had been clinically tested”. Off-label prescriptions are a similar offense. The FDA tests all therapies on a specific disease, and the pharmacies sell the approved drugs for that condition only. But doctors can prescribe them regardless, and this is called off-label and no one dares to call the doctor a con-man.

Again, I am not defending this particular stem cell clinic. I am not defending stem cells. What I am defending is the right of an individual to make an informed decision on their own, with-out interference from institutions that would have you believe that they are infallible, but in fact they are far from that. (As the thousands of deaths that occur annually from FDA approved drugs attest).

Another thought goes to the pace of progress in the current USA driven research model. Yes, you will argue that the pace of progress must be slow in order to ensure optimal safety and effectiveness. Sure, I understand all that. But tell that to someone whose life is slipping away from them. Tell that to a family who is watching their child suffer each day.

My thought is that there must be room for a fast track. If you want to take the slow and safe route because you feel better about that approach, that is fine. However, there should be fast track options for those who do not have the luxury to wait. In many cases, this is exactly what doctors do with off-label prescriptions. It is also what clinics operating outside the USA and offering potentially dangerous, but potentially groundbreaking treatments are offering. There needs to be a place for this fast track approach and by definition, if it’s not approved by the APA and the FDA, it should not be called a con.

People are smarter then professionals would like to admit. We need to challenge the status quo. We need to demand results based funding. We need some doctors and researchers to live each day like it was soon to be their last in order to accelerate the pace of discovery.

60 Minutes – Stem Cell Fraud

Multipotent progenitor cells in rats with hypoxic-ischemic injury

Multipotent progenitor cells in rats with hypoxic-ischemic injury

Cell Transplant. 2006;15(3):231-8.
Behavioral and histological characterization of intrahippocampal grafts of human bone marrow-derived multipotent progenitor cells in neonatal rats with hypoxic-ischemic injury.

Yasuhara T, Matsukawa N, Yu G, Xu L, Mays RW, Kovach J, Deans RJ, Hess DC, Carroll JE, Borlongan CV.

Department of Neurology, Medical College of Georgia, Augusta, GA 30912, USA.

Children born with hypoxic-ischemic (HI) brain injury account for a significant number of live births wherein no clinical treatment is available. Limited clinical trials of stem cell therapy have been initiated in a number-of neurological disorders, but the preclinical evidence of a cell-based therapy for neonatal HI injury remains in its infancy. One major postulated mechanism underlying therapeutic benefits of stem cell therapy involves stimulation of endogenous neurogenesis via transplantation of exogenous stem cells. To this end, transplantation has targeted neurogenic sites, such as the hippocampus, for brain protection and repair. The hippocampus has been shown to secrete growth factors, especially during the postnatal period, suggesting that this brain region presents as highly conducive microenvironment for cell survival. Based on its neurogenic and neurotrophic factor-secreting features, the hippocampus stands as an appealing target for stem cell therapy. Here, we investigated the efficacy of intrahippocampal transplantation of multipotent progenitor cells (MPCs), which are pluripotent progenitor cells with the ability to differentiate into a neuronal lineage. Seven-day-old Sprague-Dawley rats were initially subjected to unilateral HI injury, which involved permanent ligation of the right common carotid artery and subsequent exposure to hypoxic environment. At day 7 after HI injury, animals received stereotaxic hippocampal injections of vehicle or cryopre-served MPCs (thawed just prior to transplantation) derived either from Sprague-Dawley rats (syngeneic) or Fisher rats (allogeneic). All animals were treated with daily immunosuppression throughout the survival period. Behavioral tests were conducted on posttransplantation days 7 and 14 using the elevated body swing test and the rotarod to reveal general and coordinated motor functions. MPC transplanted animals exhibited reduced motor asymmetry and longer time spent on the rotarod than those that received the vehicle infusion. Both syngeneic and allogeneic MPC transplanted injured animals did not significantly differ in their behavioral improvements at both test periods. Immunohistochemical evaluations of graft survival after behavioral testing at day 14 posttransplantation revealed that syngeneic and allogeneic transplanted MPCs survived in the hippocampal region. These results demonstrate for the first time that transplantation of MPCs ameliorated motor deficits associated with HI injury. In view of comparable behavioral recovery produced by syngeneic and allogeneic MPC grafts, allogeneic transplantation poses as a feasible and efficacious cell replacement strategy with direct clinical application. An equally major finding is the observation lending support to the hippocampus as an excellent target brain region for stem cell therapy in treating HI injury.

PMID: 16719058 [PubMed – in process]

Neural Stem Cell Injection Into Spine

Stem Cells burst into the public spotlight several year’s ago with promises to cure almost any disease or injury, including brain injury.  Unfortunately, progress has been slow, partly because of complex ethical and regulatory issues.   In China (and other countries such as Mexico, India, Turkey, Russia), there are hospitals that have been using stem cells to actively treat humans.

This is obviously very interesting.   As of January 2012 BRIGHT does not have any first hand knowledge as to the safety or effectiveness of this treatment.  However, we are very interested to be contacted by anyone who has undergone treatment at this facility or similar around the world.

Also of note is that as of January 2012 China has ordered a halt to all unapproved stem cell treatments.  However, it is reported that hospitals that are run by the military or police forces are not under the control of the same regulatory bodies and therefore are not effected by the ban.   More information on this can be found here:

Beijing bans stem cell studies

Unapproved stem cell treatments stopped in China

We have found one website is clearly commercial in nature.  It describes improvements in vague terms.  It acknowledges the risks, but does not attempt to quantify the risks or the improvements.

Here is the contact information for the program as well as the website.    Again, we would be very interested to learn of anyone with first hand knowledge of treatment by Neural Stem Cell Injection directly Into Spine, or other similar treatments.

—————
Address: China Stem Cells Medical Center #198 Fengbao Road, Fengtai District, Beijing, 100160, People, s Republic of China
Stem Cells Treatment of Cerebral Palsy

 We have recently developed a comprehensive program for Cerebral Palsy patients combining both nerve stem cell activation and stimulation treatment, and stem cells injections. This combined treatment has so far proven itself to be the most effective means to achieving a high level of recovery. 

The treatment includes stem cell implantation, a “cocktail” of medications and brain nutrition materials given through IV, biofeedback treatment and comprehensive rehabilitation.

By employing all of the above methods we can maximally improve functions such as sensibility, mobility, language and intelligence. 

The key to the success of this treatment method is the overall customized treatment regimen for each patient.

Self Stem Cells Activation and Proliferation:

Using a non-invasive procedure, through daily IV of an individually customized cocktail of neurotrophic medications, we activate the patient´´s own stem cells and as a result, turn these cells into nerve precursor cells. These cells have signalization and migrate to lesions along the nerve developing-chord.

Neural Stem Cells Injections:

Neural stem cells extracted from a fetus have the advantage of already being specialized naturally into neural cells and therefore there is no need to induce them into becoming neural cells by artificial means.

We offer a safe stem cell implantation procedure for Cerebral Palsy patients. The procedure includes: Sub-arachnoid Surgery, spinal cord fluid stem cell injections, and an injection through a lumbar puncture into the spinal cord fluid.

We use this technique in the following cases:

1. The patient cannot cooperate properly for going through sterotaxios brain surgery.

2. The target in the brain is not clear enough to use the brain injection.

This procedure takes between 5 and 10 minutes. It is a simple and safe procedure that has almost no side effects or risks. This procedure takes place in the operating room and is performed by stem cell specialists.

Typically, 3 or 4 injections of 5 million cells each are given to the patient.

 

Rehabilitation:

Rehabilitation therapy is a very necessary part of the whole treatment regimen. In the past 20 years nerve system rehabilitation, in terms of motor control theory, has been greatly developed. The research results indicate that brain injury is an anatomical injury and it does not necessarily mean functional loss. Modern Nerve Development Theory (NDT) focuses on what functions remain and what functions can be regained through treatment and/or training.

 

The adult stem cell mobilization technique we use is combined with signal induction in the rehabilitation training procedure which can significantly improve brain function.

 

In our Rehabilitation Center we use different kinds of rehabilitation methods including: Physical Therapy, Occupational Therapy and Speech Therapy.

 

The Procedures:

Self stem cell activation and proliferation program

This program usually requires a 4 to 5 weeks staying in the Hospital.

1. Upon arrival at the hospital, you will be given standard tests to check your health and the details of your condition. A thorough evaluation of the neurological function and understanding of the lesion or pathological change in the brain tissues will be established by the medical team.

2. According to your condition a medical plan will be designed for Self Stem Cell Original Activation and Proliferation treatment. Then, to drive off the trigger factors of the stroke, we will treat the blood vessel wall, the blood ingredients and the blood flow, improving the brain microenvironment to help the stem cells proliferate.

3. The self activation and proliferation treatment will then start. Based on the Neuro-endocrine Immune Network Theory, we treat the patient by “waking up” the sleeping stem cells through oral medication. We use different medications during different processes (proliferation-inducement-differentiation), the medications are always adjusted and combined; therefore, we call it a “cocktail treatment.”

4. Throughout the treatment period we will be following up and evaluating your neurological function and improvement.

5. After the first treatment cycle is complete, 2 to 5 months of rest are recommended before starting the second treatment

Stem Cell Implantation through the Cerebral Spinal Fluid (Lumbar Puncture)

Most Cerebral Palsy patients have global brain damage. That is why we recommend doing the stem cells implantation through the spinal cord fluid. Through the CSF the stem cells will migrate to the damaged areas in the brain. This procedure is short and simple and done with local anesthesia.

In order to prevent even the minor risk of infection and maintain a strictly sterile environment, the procedure is done in the operating room by our doctors only.

Side effects:

The procedure can cause minor side effects for 2 to 3 days after the operation including fever, headaches, dizziness and fatigue. These side effects are expected and should not alarm or concern you. Many patients do not suffer any side effects at all.

Treatment period:

The recommended time period for the treatment is 4 to five weeks, but there should be improvement after the first month. The patient can decide whether or not to continue with the second month´´s treatment at the end of the first month.

Written by Dr. Like Wu and Dr. Xiaojuan Wang

What are Neural Stem Cells?

Neural Stem cells are self-regenerating, multipotent cells, found in the human brain which have the potential to differentiate into three major cell types: nerve cells (neurons), astrocytes and oligodendrocytes, and to self renew sufficiently to provide adequate number of cells in the brain.

When brain cells are damaged or are dying, due to a disease or an injury, fetal stem cells are the best known source for human neural stem cells.

Since most brain injuries, stroke, degenerative diseases and Demyelinating disorders affect several areas in the brain and not only one, the most effective and safe procedure to deliver neural stem cell into the brain is via a Lumbar Puncture (also called Spinal Tap): a spinal injection in the lumbar area (lower back) into the CSF (Cerebral Spinal Fluid).