The Don Margolis Blog
Featuring the most comprehensive collection of "disease specific" stem cell treatment articles in the world. We provide the most current, factual and comprehensive information on available stem cell treatments today for your specific medical condition.
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INTRODUCING
from a Hint of Halite Productions…in conjunction with a Speck of NaCl…
THE 510(K)
FAST TRACK
REVIEW PROCESS!
Do you have a new product or medical device?
Is it defective “with the potential for life-threatening or serious, permanent harm“?
NO PROBLEM!!
We can still bring it to market!
If you can prove that it is similar to an existing product, we can fast track it using the 510(k) review process!
NOW SHOWING at a HOSPITAL NEAR YOU…
THE 510(K) FAST TRACK REVIEW PROCESS!
LIFE AT FULL THROTTLE!
FAST-TRACKED DEFECTIVE DEVICES!
NO LIMITS!!
Now here is the good news!
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There is NO human testing required on your device!
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There is NO manufacturing plant inspections required on your device!
From the article:
“National Research Center for Women & Families looked at medical devices recalled from 2005 to 2009 for defects with the potential for life-threatening or serious, permanent harm. They found 80 out of 113 recalled products, or 71 percent, were cleared through a shorter FDA review process known as 510(K) that was designed for low- and moderate-risk devices. The faster review allows approval if a device is similar to another on the market. The FDA usually does not require human testing or manufacturing plant inspections. Most new devices are cleared through that process.”
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Dear FDA-
This is great news! I was devastated when my brand new product failed it’s review because it is defective, has been recalled and has the potential for life-threatening or serious, permanent harm! I put so much time and money into it’s development. Your fast track review process is a life saver (yes, I know, an ironic, morbid and bad joke). Please submit my device for review under the 510(k) process as I think you will find that my device is “similar to another on the market.” In fact, it is similar for the following reasons:
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It has been recalled, so it is specifically similar to “80 out of 113 recalled products, or 71 percent” that have also been recalled.
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It is similar due to it’s being defective like so many defective devices you have approved.
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It is similar because it has the potential to be life-threatening.
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It is similar because it can cause serious, permanent harm.
I think you will have no recourse other to agree that my new device is similar and should be accepted and reviewed under 510(k) process. When it passes despite the potential for harm that it will almost definitely fulfill, as I’m sure it will, there will be even one more similarity!
Warm regards-
Defective…but now still marketable!
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Do you know why there is no fast track approval process for adult stem cell treatments? Because adult stem cell treatments are unique in that they can not prove any similarity to pre-existing defective and life threatening devices. Here is why adult stem cells just don’t get along with pre-exiting drugs, products and devices; here is the true “problem” with adult stem cells…
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They treat 130+ DISEASES around the world
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They have a 60-80% SUCCESS RATE typical therapeutic benefit
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There are RIGOROUSLY ASSESSED & SCRUTINIZED treatment centers
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There are POTENTIAL CURES of Autism, Parkinson’s, AIDs, Diabetes, Heart Disease and more
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They provide HUGE REWARDS of life extension
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They provide SIGNIFICANTLY IMPROVED quality of life
There is not ONE pre-existing product, drug, device or treatment that can claim this.
Adult stem cells are incredibly unique, like a snowflake, so…no fast track review process. Sorry guys!
But if it makes you feel any better, your choices of brand new and improved defective or life threatening products and devices that do slightly different things from previous defective or life threatening products and devices seem to be increasing in leaps and bounds! This SUV comes in red, blue, green and now….black and silver! Hooray!
Posted:
2/15/2011 9:52:07 AM by
Don Margolis | with
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Are you or a loved one interested in receiving stem cell treatment? For free information, please fill out our
treatment form or email me
don@repairstemcells.org and just put TREATMENT in the subject box and the MEDICAL CONDITION in the message.
How Nasal Stem Cells Might Prevent Childhood Deafness
Australian scientists have shown for the first time in mice that nasal stem cells injected into the inner ear have the potential to reverse or restore hearing during early onset sensorineural hearing loss.
Sensorineural hearing loss occurs when hearing cells in the cochlea lose their function. Frequently inherited, and usually starting during infancy and early childhood, the condition can slow a child’s development and lead to speech and language problems.
Drs Jeremy Sullivan, Sonali Pandit and Sharon Oleskevich from Sydney’s Garvan Institute of Medical Research, found that stem cells appear to release ‘factors’, or chemical substances, that help preserve the function of cochlear hearing cells, without the stem cells becoming part of the tissue of the inner ear. Their findings are published in Stem Cells, now online.
“We are exploring the potential of stem cells to prevent or restore hearing loss in people,” said project leader Dr Sharon Oleskevich.
“The mice we are using have a very similar form of childhood deafness to their human counterparts – except, of course, that mouse years are shorter. So a mouse will tend to lose their hearing within 3 months, where a person might take 8 years.”
“We are encouraged by our initial findings, because all the mice injected with stem cells showed improved hearing in comparison with those given a sham injection. Roughly half of the mice did very well indeed, although it is important to note that hearing was not completely restored to normal hearing levels.”
Adult human nasal stem cells were used in the procedure, because they are plentiful, easy to obtain and unspecialised (so have the ability to self-renew for long periods, as well as differentiate into cells with a variety of functions).
The same group of scientists has shown in previous publications that stem cells can also be used to improve hearing in noise-induced hearing loss – a condition that affects both young and older people.
It has taken 5 years to reach the current stage of research, and scientists anticipate that it will take a further decade at least for the findings to benefit people.
Acknowledgements
This research was supported by the Fairfax Foundation and the Australian Deafness Research Foundation. We received much help from ear surgeons at St. Vincent’s Hospital, in particular Dr John Tonkin and Professor Paul Fagan. Also from Professor Alan Mackay-Sim, Director of the National Adult Stem Cell Research Centre at Griffith University in Brisbane, who supplied the stem cells used in the project.
Source: Garvan Institute of Medical Research
Posted:
2/14/2011 9:59:12 AM by
Don Margolis | with
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treatment form or email me
don@repairstemcells.org and just put TREATMENT in the subject box and the MEDICAL CONDITION in the message.
INDUCED PLURIPOTENT STEM CELLS (IPSC) are not the stem cells we usually hear about because they are human skin cells (typically) that are regressed to an embryonic state. The problem with the is that they carry the genetic abnormalities of the donor and they form cysts and tumors like embryonic stem cells. SO they are useless for treating diseases until these problems are resolved. Or are they? Scientists have used IPSC to grow cells with Autism. They can now follow the path of the disease almost from embryo to fully mature cells and will learn a lot more about it. – dg
“Their findings, published in the Nov. 12, 2010, issue of
Cell, revealed disease-specific cellular defects, such as fewer functional connections between Rett neurons, and demonstrated that these symptoms are reversible, raising the hope that, one day, autism maybe turn into a treatable condition.
“We show very clearly that autism is a biological disease that is caused by a developmental defect directly affecting brain cells.”
Posted:
2/14/2011 9:57:34 AM by
Don Margolis | with
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don@repairstemcells.org and just put TREATMENT in the subject box and the MEDICAL CONDITION in the message.
“Scientists have created a ‘Mighty Mouse’ with muscles that stay powerful as it grows old,” the Daily Mail has reported. The newspaper said the ‘breakthrough’ paves the way for a “pill to give pensioners the strength of their youth, cutting the risks of falls and fractures in old age”.
The story comes from research on mice that found that transplanting donor muscle stem cells into injured leg muscles led to a 50% increase in muscle mass and a 170% increase in muscle size. The improvements were maintained though the lifetime of the mouse.
Posted:
2/14/2011 9:49:23 AM by
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Stem cells to hypersonic vehicles: Four young scientists win presidential award
The “early career” researchers will receive up to five years of funding from the federal government to pursue important research.
BY SUSAN YOUNG
The winners are
Dominique Bergmann, assistant professor of
biology;
Gianluca Iaccarino, assistant professor of
mechanical engineering;
Jacob Wacker, theoretical physicist at
SLAC; and
Joseph Wu, associate professor of
medicine and radiology.
The award is the highest honor bestowed by the U.S. government on outstanding scientists and engineers in the early stages of their research careers. The winners will receive research grants to pursue their research for up to five more years.
The four Stanford recipients are looking for answers in a variety of areas.
Dominque Bergmann
Bergmann studies cells of the diminutive Arabidopsis plant to understand the general rules of stem cell behavior, including how the cells balance the need for constant division without becoming cancerous. Stem cells can divide for nearly 1,000 years in some long-lived plants, and yet plants, unlike animals, don’t develop cancer. Bergmann looks at the generation of stomata, the microscopic pores on the surface of plants that allow for gas exchange, as a model for stem cells.
When a mother cell divides into two, the resulting daughter cells can sometimes differ in size and function, a process called asymmetric division. Both plants and animals use asymmetric divisions to maintain stem-cell populations. Bergmann uses the asymmetric division pattern of stomata cells to identify genes that regulate these uneven divisions.
Gianluca Iaccarino
Iaccarino‘s work focuses on computer simulation of the complex physics of “air-breathing hypersonic vehicles” – wickedly fast jet airplanes that fly several times the speed of sound. His work contributes to the understanding of turbulent flow and margins of uncertainty.
Hypersonic vehicles are envisioned as a means for reliable low-cost access to space. Their design depends on complex physics and the interactions between all of their components. The simulation capabilities of today’s state-of-the-art computing can not reliably predict the outcome of a design; the answers will require a radically new integrated approach. The Department of Energy will fund his research.
Jacob Wacker
Wacker, an assistant professor of particle physics and astrophysics, seeks to explain physics beyond the Standard Model, a set of laws governing the known particles and forces in the universe.
His research, funded by the Department of Energy, includes probing the existence of exotic particles and combing through data to validate or refute theories about the nature and origin of dark matter – a mysterious, invisible substance thought to make up nearly 80 percent of all the matter in the universe.
He also works closely with experimental physicists, offering new theories to be tested and providing theoretical explanations for the hiccups sometimes seen in experimental data sets.
Joseph Wu
Wu studies how embryonic and adult stem cells survive, proliferate and transform into other cell types. Wu approaches his research with an eye toward clinical treatment and is investigating the potential of stem cells to form tumors or be rejected by the immune system. He also works on techniques that can turn developed cells, like skin cells, into induced pluripotent stem cells without depending on possibly dangerous viruses, a risky feature of early methods.
Additionally, Wu is exploring ways to safely and effectively deliver genes to improve damaged heart cells. His grant is from the National Institutes of Health.
“These gifted young scientists and engineers represent the best in our country,” said Secretary of Energy Steven Chu, a former Stanford researcher. “The awards recognize ingenuity, dedication, diligence and talent.”
Susan Young is a science-writing intern at the Stanford News Service.
Posted:
2/14/2011 9:46:45 AM by
Don Margolis | with
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MRI contrast agents change stem cell proliferation
Tampa, Fla. (Nov. 01, 2010) – When researchers tested three different labeling agents on three different stem cell populations to determine what effect the labeling agents had on stem cell phenotype, biological behavior and migration abilities, they found changes in stem cell proliferation depending on the type of contrast agent used…
Posted:
2/14/2011 9:42:15 AM by
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This is AWESOME!
They’ve been trying to treat fetuses in the womb with stem cells for awhile now (adult stem cells, NOT embryonic! embryonic can cause tumors!) In the past, they tried to use the baby’s own stem cells…with mixed results.
“But despite the fact that the immature immune system of an unborn baby can tolerate donor transplants, with little risk of graft rejection, most previous attempts to transplant blood stem cells into a human fetus have been unsuccessful…”
BUT
“When transplants were matched to the mother rather than the fetus, the transplants were accepted!…Transplanting stem cells harvested from the mother makes sense because the mother and her developing fetus are prewired to tolerate each other.”
IMAGINE!
‘in-the-womb treatments for “everything from neurological disorders to muscular disorders before birth.”’
Two recent stories are exciting about the possibility of treating young children, even in the womb, with adult stem cells. One study shows that cardiac adult stem cells can be isolated from young children with heart problems, even as young as one day old…
Posted:
2/13/2011 9:47:42 AM by
Don Margolis | with
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treatment form or email me
don@repairstemcells.org and just put TREATMENT in the subject box and the MEDICAL CONDITION in the message.
MORE BAD NEWS ABOUT AVAILABLE US TREATMENTS FOR HEART DISEASE
Most Americans with the biggest risks for heart disease are not doing enough to control these risks, and the fragmented U.S. healthcare system is partly to blame, federal health officials said on Tuesday…
U.S. health system not helping heart disease: CDC
Posted:
2/12/2011 9:42:20 AM by
Don Margolis | with
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treatment form or email me
don@repairstemcells.org and just put TREATMENT in the subject box and the MEDICAL CONDITION in the message.
Until she was 15, Morse had 20/4,000 vision in one eye and only light perception in the other due to optic nerve hypoplasia, or an underdevelopment of the nerve that transmits vision signals from the eye to the brain. She could make out human figures but not see details, could only read if the paper was within inches of her eye, and could only watch TV standing with her nose pressed to the glass…
After raising $15,000 from community donations, the mother and daughter set out forChina on July 4…
She received spinal injections of cord blood stem cells each week for six weeks. After her third treatment, she realized she could read and knew the treatments were working…
More info on OPTIC NERVE HYPOPLASIA, SEPTO-OPTIC DYSPLASIA, MACULAR DEGENERATION and OPTIC CHEMICAL BURNS:
Treatment with adult stem cells, due to the amazing transformation from blindness to sight, are some of the most powerful success stories in adult stem cell treatments.
· Macie Morse from Colorado before stem cells had 20/4000 vision in one eye and in the other eye she only had “light perception,” she could only make out light. Also, she could only watch TV with her nose pressed against the glass. After treatment she had 20/80 vision in one eye and the other is 20/400+. She is now driving her family’s van and enjoying her new driving permit. http://repairstemcell.wordpress.com/2009/02/16/stem-cells-optic-nerve-hypoplasia-victory/
· Jakob Bielski from Canada received stem cell treatment because he couldn’t see at all and had no response to light. After the Cord Blood Stem Cells Were Implanted he has some vision, can respond to visual information and responds to light. http://donrmargolis.com/blog/2009/03/stem-cell-research-helps-canadian-boy-see-light/
· Dakota Clarke’s mother said “It’s been worth every single penny to see the changes in her.” http://donrmargolis.com/blog/2009/03/stem-cell-research-helps-blind-girl-septo-optic-dysplasia/
· Coby Fend’s mother said ““We are talking about going back — we’d almost be crazy not to, because right now it’s the best thing going in the entire world.” http://donrmargolis.com/blog/2008/08/blind-child-can-now-see-thanks-to-adult-stem-cell-treatment/
· Connor Corkern’s mother said: “He’s doing great. He is doing wonderful. It’s like we’ve got a totally new baby.” http://donrmargolis.com/blog/2009/01/stem-cell-miracle-optic-nerve-hypoplasia-adult-stem-cell/
· Cameron Petersen’s Grandma said: “There was nothing for Cameron before this treatment. Now, his world is limitless.”http://donrmargolis.com/blog/2008/12/stem-cell-therapy-for-optic-nerve-hypoplasia-american-doctor-isnt-blind-to-fact-that-it-works/
· Lydia Black’s father said: “the treatment is already having a huge effect on her life, and he is glad that she was able to receive stem cell treatment…” http://donrmargolis.com/blog/2008/06/stem-cell-research-treatment-septo-optic-dysplasia/
· Savannah Watring’s mother said: “She said hello to herself in an elevator (after seeing her reflection). It blew everyone away. We weren’t expecting that.” http://donrmargolis.com/blog/2008/08/optic-nerve-hypoplasia-helped-by-stem-cell-therapy/
· Xavier Carballo’s ophthalmologist, Dr. Jack Guggino of Tampa, said he did a baseline exam on the boy before the trip to China and after his return. Before the treatment Xavier could only detect hand motion at 1 to 2 feet, and after the treatment he could count fingers at 3 to 4 feet. “As far as Xavier is concerned, there has been definite and measurable improvement, neurologically and ophthalmologically,” Guggino said. http://donrmargolis.com/blog/2009/01/stem-cell-treatment-helps-yet-another-optic-nerve-hypoplasia-patient/
· Lawrence Brown III looks at the number “10” on a family laptop and tells his mother Georgina Brown what the number is as part of a daily exercise to see if his sight is improving. For most people, it is insignificant. But for Lawrence, 16, who has been blind since birth, it was an exceptional moment.“They call it a really good placebo effect,” Lawrence said. “Whatever, if it’s a placebo effect, I want some more.” http://repairstemcell.wordpress.com/2009/08/09/stem-cell-therapy-shows-results-el-paso-times/
· Blind Man Can See Again After Stem Cell Therapy – A man blinded after having ammonia squirted in his eye is now able to see again thanks to adult stem cells taken from his own body. Russell Turnbull, 38, from England had therapy using stem cells taken from his other eye in a research study in London. http://donrmargolis.com/Home/Blog/December-2009/Blind-Man-Can-See-Again-After-Stem-Cell-Therapy
· A study in the New England Journal of Medicine on 112 patients with corneal damage from chemical burns whom received treatment. After adult stem cell treatment, a permanent restoration of a transparent, renewing corneal epithelium was attained in 76.6% of eyes. The restored eyes remained stable over time, with up to 10 years of follow-up (mean, 2.91±1.99; median, 1.93). http://repairstemcell.wordpress.com/2010/06/24/chemically-burned-eyes-repaired-with-stem-cells/
If you or a loved one interested in receiving FREE information on currently available stem cell treatments for OPTIC NERVE HYPOPLASIA, SEPTO-OPTIC DYSPLASIA, MACULAR DEGENERATION and OPTIC CHEMICAL BURNS, please fill go here: http://www.repairstemcells.org/Treatment/Treatment-Request.aspx?d=Optic+Nerve+Disorders
Posted:
2/11/2011 9:49:40 AM by
Don Margolis | with
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treatment form or email me
don@repairstemcells.org and just put TREATMENT in the subject box and the MEDICAL CONDITION in the message.
Maxillary and mandibular radionecrosis (stage IIIR) with pathologic fracture presented early osteogenesis:
- total recovery from alveolar nerve anesthesia, facial nerve reinnervation, and skin regeneration.
- nonhealed fracture, bone loss, and bilateral paresthesia demonstrated callus formation, bone regeneration, and nerve recovery.
- maxillary bone regenerated after massive deficiency
- oral functional restoration with implants and fixed prosthesis was accomplished in all cases
Plast Reconstr Surg. 2010 Nov;126(5):1699-709.
Regenerative facial reconstruction of terminal stage osteoradionecrosis and other advanced craniofacial diseases with adult cultured stem and progenitor cells. – Mendonça JJ, Juiz-Lopez P.
Lugo, Spain From the Head and Neck Surgery Unit, POLUSA Hospital.
Abstract
BACKGROUND: Treatment options in cases of severe craniofacial disorders with bone loss and tissue damage are usually limited to vascularized and nonvascularized tissue transfers, allografts, mechanical devices and, more recently, facial transplantation. Despite the therapies available, the demand for new approaches is realized in cases where current therapies are unable to resume form and function. This study presents the feasibility of alternative treatments based on cultured bone marrow cells that yield mixed populations of mesenchymal, hematopoietic, and endothelial lineages at very early stages implemented as part of a novel regenerative procedure.
METHODS: One hundred milliliters of a bone marrow aspirate was inoculated into the automated single-pass perfusion technology system, AastromReplicell, for the development of the cellular product, tissue repair cells. After 12 days of incubation, cells were exposed to a specially designed osteogenic environment in an autogenous fibrin-rich and platelet-rich clot and membrane with a mineral base of ?-tricalcium phosphate and hydroxyapatite.
RESULTS: A case of maxillary and mandibular radionecrosis (stage IIIR) with pathologic fracture presented early osteogenesis, total recovery from alveolar nerve anesthesia, facial nerve reinnervation, and skin regeneration. Another case with nonhealed fracture, bone loss, and bilateral paresthesia demonstrated callus formation, bone regeneration, and nerve recovery. Finally, maxillary bone regenerated after massive deficiency. Oral functional restoration with implants and fixed prosthesis was accomplished in all cases.
CONCLUSION: After nerve, bone, skin, and vessel formation in three patients with severe abnormality, bone marrow-derived mixed cultured stem cell lineages could be considered a new paradigmatic approach to advanced disease.
Posted:
2/10/2011 9:57:07 AM by
Don Margolis | with
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