May 13, 2010 by

Stem Cells Regrow Crucial Hearing Cells in Mice

Hearing loss is a significant problem. According to the National Institute on Deafness and Other Communication Disorders 15 percent of Americans between 20 and 69, or 26 million people, have high frequency hearing loss caused by noise. Antibiotics and genetic disorders have also been identified as causative factors.

Recently a study led by Dr. Kazuo Oshima of Stanford University in California demonstrated that it is possible to generate the cells in the ear that are responsible for hearing from two types of mouse stem cells. By treating embryonic stem cells or a similar type of stem cell generated from the skin called "induced pluripotent stem cells", with a mixture of small molecules and proteins, the scientists where able to produce hair cells. These cells are covered with bristles called stereocilia which recognize sound waves and as they bend in response to the sound waves chemical channels open, which create an electrical signal that can be carried to the brain. Although it is dogma that once the hair cells are damaged, they cannot be replaced, some studies do suggest that adult stem cells are involved in repair after injury (Lang et al. Contribution of bone marrow hematopoietic stem cells to adult mouse inner ear: mesenchymal cells and fibrocytes. J Comp Neurol. 2006 May 10;496(2):187-201).

Oshima’s team believes the current finding has several implications. In a telephone interview he stated "What we are thinking is to get human iPS cells from hearing loss patients and just try to re-make the disorder in the petri dish." He continued "This could be used to screen drugs that might cause the cells to regenerate, or to activate hibernating stem cells in the ear, he said. It may also be possible to grow the cells and inject them into the ear, but no one has developed a technique for doing this."

When asked about the future of these experiments, Dr. Oshima commented "The next step is to try using human iPS cells, but it has not worked so far".

As a third-party assessment of the findings, Dr. David Corey, a professor of neurobiology at Harvard University in Massachusetts commented that "This gives
us real hope that there might be some kind of therapy for regenerating hair cells," but on a negative note he continued "It could take a decade or more, but
it’s a possibility."

Filed Under: News, Stem Cell Research Tagged With: , , ,
May 12, 2010 by

Stem Cells Have GPS to Generate Proper Nerve Cells

One of the main questions in stem cell therapy is how the
injected cells "know" to find their way into the specific parts of the body
where they are needed. The most common example of stem cells homing is during
bone marrow transplant. In this situation donor stem cells are administered to
the recipient intravenously, but somehow they find their way to the bone marrow
of recipient, and once in the bone marrow start producing new blood cells. It
was discovered that specific cells in the bone produce a chemical signal called
stromal derived factor (SDF)-1 that acts as a homing beacon for the stem cells,
causing them to be localized in the bone marrow regardless of where they are
injected. This is explained in the video
www.youtube.com/watch?v=VJaQkYWdJ8w.

By knowing the signals involved in keeping stem cells in
the bone marrow, drugs have been made that can temporarily release them from the
bone into circulation. One example of such a drug made by Genzyme called
Mozibil. This is a small molecule that has been synthesized to act as an agent
that blocks the interaction between SDF-1 and its receptor. By blocking this
interaction, stem cells are "mobilized" to exit the bone marrow and enter
systemic circulation. Once the drug exits circulation by normal metabolism, the
stem cells home back to the bone marrow, or if there is injury in the body, some
of them localize to the damaged area.

Mozibil and similar agents are useful in situations where
one wants to collect patient stem cells without having to perform a bone marrow
aspiration, which is a painful procedure involving drilling numerous holes in
the bone of the donor. Another use of such "mobilizers" is to increase the
number of stem cells in circulation, to accelerate recovery in conditions such
as stroke or heart attack. In both of these conditions an increase in
circulating stem cells is associated with better recovery. Thus if one
artificially increases the number of stem cells in circulation by administering
agents such as Mozibil, it may be possible to see a therapeutic benefit.

While the control of stem cell homing for the bone marrow
is relatively well-known, the brain is a completely different matter. A
previously unknown factor that regulates how stem cells produce different types
of cells in different parts of the nervous system has been discovered by Stefan
Thor, professor of Developmental Biology, and graduate students Daniel Karlsson
and Magnus Baumgardt, at Linköping University in Sweden.

The scientists studied a specific stem cell in the nervous
system of the fruit fly. This stem cell is present in all segments of the
nervous system, but outside of the nervous system it is found only in the
thorax. To investigate why this cell type is not created in the stomach or head
region they manipulated the Hox genes’ activity in the fly embryo. The
investigators found out that the Hox genes in the stomach region stop stem cells
from splitting before the specific cells are produced. In contrast, the specific
nerve cells are actually produced in the head region, but the Hox genes turn
them into another, unknown, type of cell. Hox genes can thus exert their
influence both on the genes that control stem cell division behaviour and on the
genes that control the type of nerve cells that are created.

"We constantly find new regulating mechanisms, and it is
probably more difficult than previously thought to routinely use stem cells in
treating diseases and repairing organs, especially in the nervous system", says
Thor.

The regulation of stem cell homing by Hox genes has previously been demonstrated in
other systems, however this is the first time that it was found in relation to
development of the nervous system. These findings may lead to strategies for
"rewiring" neurons after injury has occurred in situations such as cerebral
palsy or stroke.

Filed Under: News, Stem Cell Research Tagged With: , , , ,
May 11, 2010 by

Transient Inhibition of Transforming Growth Factor-{beta}1 in Human Diabetic CD 34+ Cells Enhances Vascular Reparative Functions

CD34 cells are primarily known for their hematopoietic activity, which means, that they are capable of making blood cells. More recently, studies have demonstrated that a subset of CD34 cells are capable of creating new blood vessel cells called endothelial cells. The ability to made new endothelial cells is important because old/dysfunctional blood vessel cells contribute to risk of stroke or heart attack.

Numerous disease conditions can benefit from increasing the number of healthy new blood vessels. Accordingly, studies have been conducted taking out patient bone marrow cells (which contain high concentrations of CD34 cells) and administering them either intravenously or locally in order to stimulate new blood vessel formation. This procedure has been helpful in patients with advanced peripheral artery disease www.youtube.com/watch?v=OwIOL13vXQ4 , as well as in patients with heart failure
www.youtube.com/watch?v=flv0RmzPyLU. There are several companies using patient’s own bone marrow as a source of stem cell therapy after manipulation, these include Aldagen, Baxter, Amorcyte, Micromet, and Harvest-Tech.

Unfortunately there is a problem with the bone marrow cells of patients with diabetes or other inflammatory conditions: the cells don’t work as well at making new blood vessels as compared to cells of healthy patients. One of the reasons for this is believed to be high concentrations of circulating TGF-beta in the blood of type 2 diabetics. This protein is known to suppress stem cell multiplication and is associated with the body trying to inhibit inflammation.

The study discussed in the paper Bhatwadekar et al. experimentally suppressed TGF-beta in CD34 cells from diabetic patients and asked whether this could restore the ability of the CD34 cells to generate new blood vessels.

The scientists used an artificially designed inhibitor technology called "morpholino antisense oligonucleotides" to treated CD34 cells. They demonstrated >90% suppression of TGF-beta production in the cells from diabetic patients. It was found that after inhibition of TGF-beta the ability of the CD34 cells to produce new blood vessels was substantially increased. This was demonstrated in the retinal ischemia reperfusion injury model in the mouse.

At a mechanistic level it appears that the therapeutic effects of TGF-beta inhibition were associated with increased ability to migrate to area of needed. This was demonstrated by higher expression of the receptor CXCR-4.

Filed Under: Diabetes, News Tagged With: , , , ,
May 11, 2010 by

Natural Compound in Broccoli Slows Breast Cancer Stem Cells

The area of cancer stem cells is very hot. To give an
example, the pharmaceutical company GSK recently purchased the cancer stem cell
company Oncomed for more than a billion dollars, at a time when Oncomed’s cancer
stem cell-targeting drugs were not even tested in humans. This area is of great
interest because it suggests that the way to kill cancer is not to block the
fast multiplying cells, but that the cancer has a "root cause" that scientists
for decades have been ignoring.

Cancer stem cells are usually not destroyed by chemotherapy
or radiation therapy because they are slow dividing cells that possess numerous
proteins to protect themselves from toxicity such as multiple drug resistance
proteins. These proteins have the function of identifying chemotherapy inside
of the cancer cell and actively pumping it out. It is believed that the reason
why these proteins exist is to protect cells from damage to DNA. In cancer stem
cells these proteins appear to play a role in causing relapse after
chemotherapy.

Previously it was reported that the chicken feed antibiotic
salinomycin has the ability to selectively kill cancer stem cells (Gupta PB.
Identification of selective inhibitors of cancer stem cells by high-throughput
screening. Cell. 2009 Aug 21;138(4):645-59. Epub 2009 Aug 13), additionally,
using similar testing scenarios researchers found the anti-diabetic drug
metfomin inhibits breast cancer stem cells (Vazquez-Martin et al. The
anti-diabetic drug metformin suppresses self-renewal and proliferation of
trastuzumab-resistant tumor-initiating breast cancer stem cells. Breast Cancer
Res Treat. 2010 May 11). Given the recent nature of these findings, their
use in humans has not yet been reported in the scientific literature. In the
current study which will be discussed, another compound with similar anti-breast
cancer stem cell activity was identified.

A recent study (Li et al. Sulforaphane, a dietary
component of broccoli/broccoli sprouts, inhibits breast cancer stem cells. Clin
Cancer Res. 2010 May 1;16(9):2580-90) demonstrated that a natural chemical
compound found in broccoli and other cruciferous vegetables called sulforaphane
has the ability to slow down multiplication of breast cancer stem cells.
Essentially this means that sulforaphane can block the cells that cause cancer
from being activated and thus could be an effective cancer therapy if high
enough doses can be safely administered.

The scientists purified human breast cancer stem cells
using the Aldefluor assay made by the company Aldagen, which selects for cells
expressing the enzyme aldehyde dehydrogenase, an enzyme found in normal and
cancer stem cells. The stem cells were tested to see if they would form tumors
in mice lacking an immune system called nonobese diabetic/severe combined
immunodeficient mice.

It was found that sulforaphane administered at a
concentration of 1-5 micromol/L was sufficient to suppress multiplication of the
aldehyde dehydrogenase-positive stem cell population by 65% to 80% and reduce
the size and number of primary mammospheres by 8- to 125-fold and 45% to 75%,
respectively. Mammospheres are round tumor-like structures that grow in tissue
culture plates that represent a three-dimensional cancer.

Daily injection with 50 mg/kg sulforaphane for 2 weeks
reduced aldehyde dehydrogenase-positive cells by >50% in nonobese
diabetic/severe combined immunodeficient xenograft tumors. Since it appeared
that the administration of sulforaphane eliminated breast cancer stem cells in
the animal, the next step was to assess the ability of the growing tumors to
cause secondary tumors when transplanted into other animals. This indeed was
demonstrated to be the case. Ability to block transfer of tumors to secondary
recipients is associated with possibility of cure since it represents targeting
of the functional tumor stem cell compartment.

Mechanistically it appears that sulforaphane works on the
cancer stem cells through suppression of the Wnt/beta-catenin self-renewal
pathway, which is found in numerous tumor and non-malignant stem cells. This of
course poses the question of whether the high doses of sulforaphane that were
used in the study would have unwanted effects on healthy stem cells in the
body. The most relevant side effect of chemotherapeutic drugs is suppression of
blood cell production from the bone marrow stem cell. Indeed the scientists
found that there was no alteration of blood cell parameters in treated animals,
suggesting at least a partial degree of selectivity.

Sulforaphane is believed to exert at least some of its
anticancer biological effects through its ability to suppress histone
deacetylase (HDAC) activity. HDAC are proteins that are involved in "bundling"
of the DNA. If DNA from one cell was stretched out, it would be 7 meters from
end-to-end. The histone that are acetylated bind DNA in a loose manner and
allow for new genes from the DNA to be expressed that normally would not be
expressed. In the area of cancer, the treatment with HDAC inhibitors is
believed to cause brand new expression of tumor suppressor genes. These genes,
such as p53, instruct the tumor cell to undergo cellular suicide, called
apoptosis.

The controversial "Burzynski Therapy" involving
antineoplastons, which are naturally occurring compounds is believed to function
through induction of histone acetylation and induction of tumor suppressor genes
(Burzynski, The present state of antineoplaston research, Integr Cancer Ther.
2004 Mar;3(1):47-58). It would be interesting to examine whether some of the
reported positive effects of this non-toxic cancer therapy is mediated by
suppression of tumor stem cell activity.

A recent paper (Ho et al. Dietary sulforaphane, a
histone deacetylase inhibitor for cancer prevention. J Nutr. 2009
Dec;139(12):2393-6. Epub 2009 Oct 7) demonstrated that sulforaphane inhibits
HDAC activity in human colorectal and prostate cancer cells. Based on the
similarity of sulforaphane metabolites and other phytochemicals to known HDAC
inhibitors, it was previously demonstrated that sulforaphane acted as an HDAC
inhibitor in the prostate, causing enhanced histone acetylation, derepression of
P21 and Bax, and induction of cell cycle arrest/apoptosis, leading to cancer
prevention. The possible ability of sulforaphane to target aberrant acetylation
patterns, in addition to effects on phase 2 enzymes, may make it an effective
agent in suppressing cancer cells in a non-toxic manner.

This study also poses the question if HDAC inhibitors in
general can alter tumor stem cell ability. It is known that valproic acid, the
HDAC inhibitor actually increases ability of stem cells to self renew while
being selectively toxic to leukemic cells

http://www.youtube.com/watch?v=3Hc4LCUOSiA.

An interesting note regarding cancer stem cells is that many approaches
traditionally supported by practitioners of alternative medicine may actually be
targeting these cells. In alternative medicine the main theme is providing the
body with nutrients to "heal itself". Practitioners of alternative medicine
have had some degree of success treating cancer in a "nontoxic" manner using
dramatic dietary modifications, nutrient therapy, and administration of agents
that induce differentiation. It may be possible that these interventions act to
reduce the localized inflammation in the tumor mass. This inflammation is
believed by some to be what stimulates the cancer stem cell to enter cell
cycle. Accordingly, it is interesting to see that components of broccoli
inhibit cancer stem cells. It will be interesting to examine other nutrients
for ability to target cancer stem cells.

Filed Under: Cancer, News, Stem Cell Research Tagged With: , , , ,
May 4, 2010 by

Muscular Dystrophy Sufferers Hope New Treatment Can Answer Prayers

Adult stem cell therapy has been used for many diseases
including heart failure, liver failure, stroke, multiple sclerosis, and even
drug resistant tuberculosis. The biological basis for how stem cell therapy
works seems to be two-fold. On the one hand, the stem cells appear to have the
ability to become new tissues, on the other hand, the stem cells produce various
proteins that stimulate the body to heal itself. One condition for which stem
cell therapy may offer great hope is Duchenne Muscular Dystrophy, a disease in
which muscle cells deteriorate due to the presence of a mutated gene (dystrophin)
whose protein produce is involved in muscle contraction.

Researchers from Cellmedicine in collaboration with
Medistem has previously published a case report in the peer-reviewed literature
demonstrating improvement in a Duchenne’s patient treated with mesenchymal stem
cells (Ichim et al. Mesenchymal stem cells as anti-inflammatories:
implications for treatment of Duchenne muscular dystrophy. Cell Immunol.
2010;260(2):75-82). The patient described in the paper, Ryan Benton, was
the subject of a previous news report which is available at

http://www.youtube.com/watch?v=Jyt2LHayjcs.

Today a news report was published describing follow-up on
Ryan Benton as well as another Duchenne’s patient Ian Conner that was treated
with stem cells by Cellmedicine.

Ryan and Ian have known each other all of their lives,
having watched their condition progressively deteriorate. Last year Ian’s
condition substantially worsened.

"At the time, I didn’t think I was going to live much
longer," Conner said. His mother Laurie Conner stated "Last year, I thought it
would be very soon that he would be dying. We needed to get ready, because he
was so sick, in bed a lot and he felt terrible." However there was a glimmer of
hope. Ian’s mother told him about the response Ryan had after receiving stem
cell therapy.

"We got a muscle biopsy back and it has produced dystrophin
and it’s producing normal amounts of dystrophin," Ryan said. He continued "The
main difference I’ve noticed I’ve gained a lot of weight I was down to 77
pounds."

The treatment appears to show greater effects the more
times the stem cells are injected. Both Ian and Ryan are hoping that stem cell
therapy for Duchenne’s will one day be approved in the United States so that
they do not have to travel outside of the country.

Dr.
Riordan has been in discussions with various organization and welcomes any input
on collaborations that can be used to accelerate implementation of this approach
through the Food and Drug Administration.

Filed Under: Muscular Dystrophy, News, Stem Cell Research Tagged With: , , ,
April 18, 2010 by

Saginaw stem-cell therapy study breaking new ground

Use of stem cells for treatment of degenerative diseases offers great hope. Unfortunately, this hope is tempered by practical
considerations. For example, in patients with heart attacks it is known that readministration of their own stem cells into the infarct related area results in profound improvement
http://www.youtube.com/watch?v=flv0RmzPyLU. The problem with this is that stem cells need to be extracted from the bone marrow of the heart attack patient, which is a difficult and invasive procedure, and additionally the patient’s stem cells need to be processed extensively before they can be re-infused. To compound the problem, the stem cells from patients with heart attacks usually have suboptimal function. Therefore novel ways of performing stem cell therapy are needed that would make this approach practical.

Osiris Therapeutics has developed a clinical product called Prochymal, that consists of expanded bone marrow mesenchymal stem cells. This product has been demonstrated safe by intravenous infusion and perhaps more importantly, does not require matching with the recipient. Currently Osiris has completed Phase III trials and is in discussions with the FDA regarding its commercialization path for this product.

Recently Osiris completed a Phase I trial using Prochymal for treatment of post infarct pathological cardiac remodeling. These results were positive and prompted the company to initiate a Phase II study. Part of this study is being conducted at Michigan Stem & Regenerative Medicine Program of the Michigan CardioVascular Institute and Covenant Health Care under the leadership of Dr. Safwan Kassas, an interventional cardiologist .

"Stem cells represent a promising cardiac research avenue, given their potential to preserve heart function in at-risk patients," Kassas said. "Cardiologists today are unable to reverse cardiac deterioration following a severe heart attack."

To date 2 patients, William C. Smith, 60, of Bay City, in December, and Brenda Sigmund, 62, of Caro, in January where infused with the Prochymal product.

Kathleen Mostek, director of research and regenerative medicine for MCVI, 1015 S. Washington in Saginaw, said the stem cells were taken from five volunteers, grown in a lab and stored in a bank in a freezer. He stated "This protocol is adult stem cells, they are the same for everyone in the world, with no rejection,".

The study is a double-blind, placedo-controlled stem cell investigation being conducted in the U.S. and Canada and will enroll about 220 patients. To be eligible for the trial, patients must have experienced their first heart attack within seven days.

Filed Under: Adult Stem Cells, News, Stem Cell Research Tagged With: , , ,
April 12, 2010 by

Magnetic Attraction of Stem Cells to Injured Heart Creates Potent Treatment

The intracoronary administration of bone marrow stem cells in patients who have suffered a heart attack has been demonstrated to cause beneficial effects in double blind studies, as discussed in this video http://www.youtube.com/watch?v=flv0RmzPyLU. Intracoronary administration has potential side effects since a balloon needs to be expanded in the area where the heart attack occurred, which may cause exacerbation of the existing damage. A more attractive method of stem cell delivery would be via the intravenous route. Unfortunately, intravenous administration has the drawback that some of the cells become lodged in organs such as the lung and liver.
Despite this, intravenous administration has demonstrated positive results, for example in a clinical trial conducted by Osiris (Hare et al. A randomized, double-blind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction. J Am Coll Cardiol. 2009 Dec 8;54(24):2277-86) an improvement in heart pumping
ability was observed.

One way of improving stem cell homing to the area of need is through direct administration of proteins, or genes encoding the proteins, that specifically attract stem cells. This approach has been performed with SDF-1 in animal models, and now the company BioHeart is doing Phase I clinical trials. Other ways include the use of laser therapy to induce expression of stem cell homing molecules as being developed by the San Diego company Entest Biomedical.

Today a new approach was reported in the journal Circulation Research, which is published by the American Heart Association.
Scientists at Cedars-Sinai Heart Institute have loaded stem cells with iron-nanoparticles and administered them intravenously in animals that were induced to undergo a heart attack by ligation of the coronary artery. The scientists found that by
applying magnetic fields to the heart, they could increase the number of injected stem cells that lodged into the heart by 3-times. This was accompanied by functional improvement.

"Stem cell therapies show great promise as a treatment for heart injuries, but 24 hours after infusion, we found that less than 10 percent of the stem cells remain in the injured area. Once injected into a patient’s artery, many stem cells are lost due to the combination of tissue blood flow, which can wash out stem cells, and cardiac contraction, which can squeeze out
stem cells. We needed to find a way to guide more of the cells directly to the area of the heart that we want to heal." Said Eduardo Marban, M.D., director of the Cedars-Sinai Heart Institute.

Commenting on the success of the present study, he stated "This remarkably simple method could easily be coupled with current stem cell treatments to enhance their effectiveness."

Filed Under: Adult Stem Cells, Heart Disease, News, Stem Cell Research Tagged With: , ,
April 12, 2010 by

Using Stem Cells to Study Alcohol Dependence

One of the major advancements in the area of stem cell research has been the establishment of techniques for "retro-differentiating" of old cells into younger cells. Perhaps one of the best examples of this is the discovery by the Japanese group of Yamanaka the skin cells can be coaxed to take the resemblance of embryonic stem cells by transfection with 4 genes. These cells, called inducible pluripotent stem (iPS) cells have numerous applications in many fields.

From a therapeutic perspective, iPS cells allow for the first time the possibility of "reprogramming" adult cells into younger cells, thus opening the door to autologous stem cell therapy for tissue regeneration. In other words, the therapeutic dream of iPS is for one day to be able to take patient skin cells, transform them into stem cells, and then have a large supply of young cells that can be used for repairing any organ of the body.

The other major area in which iPS cells have made a major contribution is in the field of basic research/drug development. Currently when scientists develop new drugs the drugs are tested in human cancer cells that resemble the tissue that the scientist is interested in. So if someone was developing a drug to stimulate pancreatic cells to produce more insulin, the drug initially would be tested on insulinoma cells. If the drug has some positive effects it is then tested in animals, and if successful, in humans.
There are several problems with this model. The first is that many times the cancer cell lines that resemble healthy tissue do not resemble it well. This causes a lot of drugs that appear to work in cells not to work in animals. To some extent this problem is addressed by using cells derived from humans that are not cancerous. The drawback with this is that human cells are expensive and
possess great variability.

Since iPS cells are capable of generating human cells that are "younger", and since they can be created from skin of people with various diseases, the use of iPS cells to generate cells for drug testing has become very popular. For example, if someone wants to study the effects of drugs on ALS, neurons from ALS patients can be easily created from iPS cells in larger quantities than can be extracted from cadaver sources. Dr. Stormy Chamberlain from the UConn Health Center is performing work using iPS cells to develop an in vitro model of alcoholism. Specifically, skin cells will be extracted from alcoholic and non-alcoholic patients. iPS cells will be generated from these skin cells, and then converted into neurons in tissue culture. The neurons will be assessed for abnormalities that are specific to the alcoholic patients.

A collaborator, Dr. Jonathan Covault stated "As proof of principle, we have used skin cells from six subjects to generate pluripotent stem cells, and we have successfully created neural cultures from three of these to develop mature neurons," says Covault. "Going forward, we will compare neurons derived from healthy subjects with those from alcohol-dependent patients. We’ll be evaluating their ability to support electrical signaling and form neuron-to-neuron connections, as well as their pattern of chemical and gene expression responses to single and repeated exposures to alcohol."

Filed Under: News, Stem Cell Research Tagged With: , , , ,
April 12, 2010 by

Stem-cell therapy feels Food and Drug Administration’s pinch

62-year-old Hal Kaye had an injection of his own stem cells into his injured ankle, the results were so astonishing that he no longer needed surgery. The treatment, developed by a Broomfield doctor, has been applied to over 500 patients in the United States, primarily for orthopedic conditions, and involves extraction of bone marrow stem cells, expansion of the cells, and subsequent readministration.Three years after administration of the stem cells, Hal Kay says "I can walk anywhere now. It’s been an incredible recovery." Mr Kay no longer needs to use his cane and has reported a significant improvement.

Unfortunately the treatment has resulted in concerns by the Food and Drug Administration.In 2008 the FDA sent the Broomfield doctor
a letter stating that since the procedure was not approved according to regulator channels such as a Biologics License Application (BLA). Typically cell therapy falls into the category of a "biologic" and therefore requires 2 successful Phase clinical trials before it can be sold to the general population. The doctor was asked by the FDA to provide a response detailing "steps you have taken or will take to address the violations."

While the doctor claims to have responded to the FDA, no formal reply to his response was provided he stated. His position is that a person’s own stem cells, despite being expanded in tissue culture in a laboratory, are not a drug.

Currently the doctor has assembled a team of colleagues and will be meeting with the FDA to present their position that stem cell therapy using cells from the same patient should be regulated as a medical practice and not as a new drug.His argument comes in
part from the example of in vitro fertilization, an area of medicine that is regulated by a peer-reviewed panel but not by the FDA.

Interestingly, not all doctors have followed the approach of going against the FDA’s position. Companies such as TCA Cellular
Therapy from Louisiana are applying to the FDA for clinical trials and are currently conducting controlled experiments in order to obtain approval through the regular channels. This is despite the fact that they are using stem cells from the same patient.

In the opinion of most biotechnology companies we discussed with, the outcome of the discussions with the FDA will be of great
importance.Regulation of autologous therapies has been around for decades. Before stem cells became popular, the use of patient’s own immune cells such as dendritic cells or T cells also required FDA approval. This has set up the current paradigm for
developing cell-based therapies.In our opinion the use of patient’s own stem cells without expansion may in some
situations be acceptable for performance without FDA review, however, expanding cells in tissue culture is a very complex and difficult procedure. It will be important for the FDA to regulate this since there are numerous possibilities for non-pure cell products being used if the industry is unregulated.

Filed Under: News Tagged With: , ,
April 12, 2010 by

Can A Nutritional Supplement Grow Stem Cells?

The Center for Improvement of Human Functioning International (CIHFI) was lead author on a peer reviewed study published in the
Journal of Translational Medicine http://www.translational-medicine.com/content/pdf/1479-5876-8-34.pdf describing how Stem-Kine, a commercially available nutritional supplement, significantly elevated levels of two types of stem cells in circulation.

This appears to be the first publication in the peer-reviewed literature describing a non-drug having the ability to increase
levels of the body’s own "repair cells". There is another nutrient that supposedly increases stem cells in blood, however the elevation is only 25% and this occurs only over the period of 1 hour. In contrast, the current study demonstrated increased stem cell activity in the blood over a 2 week period.

"The focus of our Institution for the past 35 years has been assisting the body to heal itself using natural, non-toxic approaches, which have provided benefit for patients with degenerative diseases. Today’s findings support, at a cellular level, how some of our interventions may be functioning," said Dr. Nina Mikirova, lead author of the study.

The study described in the publication examined 18 healthy volunteers who received oral Stem- Kine administration in the morning and at night. Circulating endothelial progenitor cells, which are involved in healing blood vessels, and hematopoietic stem cells, which produce various healing growth factors, were significantly increased as compared to pre-treatment values. Given that both endothelial progenitor cells and hematopoietic stem cells are involved in acceleration of tissue regeneration and healing, it may be
possible that Stem-Kine could improve outcomes in conditions ranging from diabetes to heart failure, to neurodegenerative conditions.

"We congratulate Dr. Mikirova and her team of Industry and University collaborators for applying the objective scientific method to the area of nutritional modulation of health." Said Brian Riordan, CEO of CIHFI. "It is the Center’s vision to integrate patient observations with detailed cellular and molecular biology in order to provide the best care for our patients."

Stem-Kine is produced by Aidan Products and can be purchased from the website www.stem-kine.com.

Filed Under: News, Stem Cell Research Tagged With: ,
« Previous Page
Next Page »