Legendary Texas Football Coach and Stem Cell Recipient Sam Harrell Returns to Coaching

Sam Harrell Stem Cell Patient for MS

Coach Sam Harrell at Ennis High School

In 2010, the debilitating effects of multiple sclerosis forced Sam Harrell to retire from his position as Head Football Coach at Ennis High School. But after receiving 3 courses of stem cell therapy at the Stem Cell Institute in Panama, Sam is returing to the gridiron once again.

Brownwood Lion Head Coach, Bob Shipley announced that Harrell will be joining the team as quarterback coach.

Sam coached all three of his sons at Ennis High School, most notably his son Graham Harrell. Graham was a standout quarterback at Texas Tech and now plays for the Green Bay Packers.

During his career at Ennis, Harrell pioneered the spread offense that led the team to three Texas state championships.

“I told the kids this morning,” said Coach Shipley when asked about how he addressed the team, “And I didn’t have to explain who Sam Harrell was, they knew. And they just erupted in applause and they were just looking at each other with their jaws dropped open, like they couldn’t believe that Coach Harrell was going to come and be apart of our staff.”

“Sam just really liked the thought of coming and not being the head coach and not being the offensive coordinator, but just coaching the quarterbacks, which is really what his passion is.”

The Stem Cell Institute was founded in 2005 by Neil Riordan PhD and has treated over 1,500 patients to-date. Find out more about stem cell therapy for MS at www.cellmedicine.com

New Stem Cell Therapy Guidelines Approved in Texas

The Texas Medical Board has approved new rules regulating adult stem cell therapies similar to the ones used to treat Governor Rick Perry last summer, the Associated Press (AP) reported on Friday.

The rules were drafted by the state board, which licenses and disciplines doctors, at the request of Houston’s Dr. Stanley Jones, the same man who in July 2011 injected Perry with the governor’s own stem cells in order to help him recover from a back injury, Nathan Koppel of the Wall Street Journal said.

Koppel noted that the new regulations will make it easier for medical professionals in Texas to offer the experimental treatments without needing to obtain federal approval, while the AP added that the rules to require patients to provide their express consent to the procedure, as well as receive approval from a review board before the stem cell therapy is permitted to begin.

“We know this is far from a perfect policy, but our hope is that this affords people in Texas seeking this therapy some protection,” Texas Medical Board President Dr. Irwin Zeitler told Todd Ackerman of the Houston Chronicle. “The wheels of federal government move so slowly – we’re not willing to wait to protect our patients.”

The rules were approved by a 10-4 vote, and members of the board have promised that they will consider revising and improving the policy as early as June, when they meet again, Ackerman said. The official start date for the new policy was not announced, but staffers told the Chronicle that it will be at least 30 days.

While Perry has lauded the stem cell treatment he has received, not everyone shares his enthusiasm for the procedure, according to Minjae Park of the New York Times.

Some researchers argue that the evidence of stem cell injections is anecdotal in nature, and that the results of clinical trials should ideally be obtained before doctors are allowed to perform the treatment, which can cost tens of thousands of dollars, added Park.

Leigh Turner, a professor at the University of Minnesota’s Center for Bioethics, told the New York Times, that there were “some real problems” with the Texas regulations, adding that the “protective mechanism that they’re focusing on” would not be able to do terribly much.

Mario Salinas, the director of Texans for Stem Cell Research, countered that the rules would protect patients and help eliminate treatments without some kind of oversight. As he told Park, “Doing something at this point is better than doing nothing… This is just the first step.”

Making Blood Cells into Heart Cells

Vojdani et al. Hum Cell. 2011 Mar;24(1):35-42
One of the major debates in the area of stem cell therapy is whether adult stem cells are capable of directly transforming (differentiating) into new tissue, or whether the therapeutic effects of administered stem cells occur because of growth factors produced by the injected stem cells. There are supporting data for both possibilities. The direct differentiation of adult stem cells into damaged tissue is supported by studies showing donor-derived adult tissue formed in patients treated. However in many situations that amount of new tissue found is relatively small. Supporting the “growth factor” hypothesis are numerous studies showing that administration of the tissue culture media that the stem cells have been grown in is capable of eliciting therapeutic effects.
Besides adult stem cells differentiating into other cells, there is some belief that other cells of the body are capable of this “transdifferenetiation” ability. For example, there was some work suggesting that B cells are capable of transforming into monocytes. There is some similarity between memory T and B cells with stem cells in that both of them express telomerase in a similar manner as stem cells. Therefore it would be interesting to see if B or T cells may express potential for differentiation into other cells. This is what was investigated in a recent paper (Vojdani et al. Cardiomyocyte marker expression in a human lymphocyte cell line using mouse cardiomyocyte extract. Hum Cell. 2011 Mar;24(1):35-42)
The investigators used a human B cell line called Raji. These cells are immortalized, therefore they may express some of the properties associated with pluripotency. What I mean is that generally cancer cells seem to start reexpressing proteins associated with “earlier” cells and possibly stem cells. For example, cancer cells are known to start re-expressing embryonic stem cell markers such as Oct-4 (Huang et al. Med Oncol. 2011 May 1).
Usually stem cells are made to differentiate into various tissues by exposing them to extracts of the cells that you want them to become. By extracts is usually meant the protein content of the cells after breaking up the cells either through freeze-thaw, sonication, or hypotonic lysis. In the current experiment the Raji cells were “retrodifferentiated” by treatment with 5-azacytidine, which is a DNA methylase inhibitor, as well as the HDAC inhibitor trichostatin A. These chemicals act to remove methylation of the cells, as well as to “open up” the histones by allowing for histone acetylation, respectively. To these undifferentiated cells the extracts from mouse heart cells were added. An interesting method of adding the extracts was used. The cell membrane was temporarily permeabilized and the extracts were added.
After 10 days, 3, and 4 weeks the cells started adhering and expressed a morphology similar to heart cells. Interestingly the cells stated expressing myosin heavy chain, α-actinin and cardiac troponin T after 3 and 4 weeks. Flow cytometry confirmed these data. In cells exposed to trichostatin A and 5-aza-2-deoxycytidine and permeabilized in the presence of the cardiomyocyte extract, troponin T expression was seen in 3.53% of the cells and 3.11% of them expressed α-actinin. These data suggest that pluripotency may be expressed by cells other than conventional stem cells. These experiments are similar to those performed by Collas’ group who demonstrated that administration of cytoplasm from Jurkat T cells to fibroblasts is capable of inducing the transdifferentiation of fibroblasts into cells that express T cell receptor and are capable of secreting IL-2 in response to ligation of the T cell receptor. This reminds us of the opposite of reprogramming by nuclear transfer (eg cloning).

New stem cell study promises to heal the heart

Miami Herald, Fred Tasker ftasker@MiamiHerald.com
University of Miami cardiologist led by Dr. Joshua Hare reported success in a small, preliminary human clinical trial of a new stem cell therapy they hope some day will routinely mend human hearts and reduce the need for lifelong medication, possibly even for transplants. The study was published in the peer reviewed journal Circulation Research (Williams et al. Circ Res. 2011 Apr 1;108(7):792-6.).
In the study eight patients of approximately 57.2±13.3 years of age received transendocardial, intramyocardial injection of their own (autologous) bone marrow stem cells (mononuclear or mesenchymal stem cells) in left ventrical scar and border zone. All patients who underwent the procedure had no serious adverse events. Cardiac MRI at 1 year demonstrated a decrease in end diastolic volume (208.7±20.4 versus 167.4±7.32 mL; P=0.03), a trend toward decreased end systolic volume (142.4±16.5 versus 107.6±7.4 mL; P=0.06), decreased infarct size (P<0.05), and improved regional LV function. This study is different than previous studies performed by Dr. Hare’s group that used stem cell administration intravenously. The belief is that directly placing the stem cells into the heart muscle may cause better therapeutic effects as compared to injection intravenously and letting them home to where they need to be. “That’s the Holy Grail, the quest the whole field has been pursuing for close to a decade, and this is evidence we’re on the right track,” said Dr. Joshua Hare. He did, however, emphasize that the current trial is only a small, run-up phase of extensive testing that will take up to five years and involve dozens of hospitals and hundreds of patients before obtaining U.S. Food and Drug Administration approval for routine use. The trial was primarily about the safety of the procedure, and all eight patients came through without significant side effects, he said. The procedure also reduced the size of hearts swollen by previous heart attacks, a condition called cardiomyopathy or simply heart failure. Max Eaton, the 68-year-old direct-buy franchise owner who was patient No.1 said that he is thankful he was part of the trial, adding that he had just completed a 2.8-mile, 41-minute walk around his neighborhood in Lauderdale-by-the-Sea. “I feel very grateful,” he said. “Almost certainly, I would be deceased or in much worse shape had I not had the opportunity to be in this program.” Eaton’s part of the testing is finished. He says he’s glad he took part, even though it hasn’t quite turned him into an Olympic runner. “I still get chest pains at times. It depends on the time of year. I had my heart attack 11 years ago in the fall. That’s when I get them,” he said. But he adds: “I’m not ready to go. I’ll keep going as long as I can enjoy what’s to be enjoyed.” An explanation of stem cell clinical trials for heart failure may be seen at in one of our videos, presented on this link http://www.youtube.com/watch?v=JfSdCYFNdPw

Medistem Inc. to Add Kidney and Lung Failure to Clinical Trials of Endometrial Regenerative Cells (ERC) Stem Cells in Russia

SAN DIEGO, CA and PORTLAND, OR, Mar 05, 2012 (MARKETWIRE via COMTEX) — Medistem Inc. (pinksheets:MEDS), in partnership with its Russian licensee, ERCell, announced the signing of a letter of intent* to begin clinical trials using Medistem’s Endometrial Regenerative Cells (ERC) stem cells for renal, lung and peripheral artery disease. Trials will be conducted in the S.M. Kirov Military Medical Academy in St. Petersburg, Russia. Under the agreement, Medistem, ERCell and the Academy will work together to a) Design and obtain approval for clinical trials; b) Provide training and execute the trials; and c) Identify opportunities for commercialization of the ERC product through existing military and governmental programs.

Under the license agreement, Medistem receives cash and royalty revenues from Russian developmental activities as well as all the data gathered from the trials. According to the agreement, work performed by ERCell will be conducted according to international “Good Clinical Practices” (GCP) so the data gathered can be used for Russian registration as well as to support US FDA submissions.

“At Medistem, our philosophy has always been to follow the data. We aim to be as aggressive as possible, to obtain as much data as possible, as quickly as possible,” stated Thomas Ichim, CEO of Medistem. “We are especially optimistic about the possibility of obtaining human data in renal failure patients, something that we otherwise would not have pursued at this stage if it weren’t for the support of the S.M. Kirov Military Medical Academy.”

“As the Medistem licensee for Russia and CIS (Commonwealth of Independent States), ERCell is committed to advancing our programs using as many non-dilutive means as possible,” said Tereza Ustimova, CEO of ERCell. “By partnering with the best institutes in the country, we are committed to making ERCell Russia’s premiere universal donor adult stem cell company.”

S.M. Kirov Military Medical Academy conducts research in the following areas: metabolic derangements of cardiovascular pathology, nanotechnologies in biology and medicine, stem cells as a basis for the treatment of internal organs and blood diseases, blood circulation, vegetative nervous system and high-tech methods of diagnosis and treatment.

“We are highly impressed by the fact that the Endometrial Regenerative Cell (ERC) is the newest stem cell product to enter clinical trials. By the higher growth factor production ability compared to other types of stem cells, we are very eager to begin clinical trials,” said Oleg Nagobovich, M.D., Chief of the Research Center, S.M. Kirov Medical Military Academy. “We feel our work will complement the ongoing work at the Backulev Center addressing heart failure by Medistem/ERCell.”

*Letter of intent issued by Ministry of Defense, dated 2/24/12, No. 411A/119

About Medistem Inc. Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company’s lead product, the endometrial regenerative cell (ERC), is a “universal donor” stem cell being developed for critical limb ischemia. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf . ERC can be purchased for scientific use through Medistem’s collaborator, General Biotechnology http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells .

Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

Contact:
Thomas Ichim
Chief Executive Officer
Medistem Inc.
9255 Towne Centre Drive, Suite 450
San Diego, CA 92122
858 349 3617
858 642 0027

www.medisteminc.com twitter: @thomasichim

SOURCE: Medistem Inc.

Autologous stromal vascular fraction therapy for rheumatoid arthritis: rationale and clinical safety.

Int Arch Med. 2012 Feb 8;5(1):5. [Epub ahead of print]

Paz Rodriguez J, Murphy MP, Hong S, Madrigal M, March KL, Minev B, Harman RJ, Chen CS, Timmons RB, Marleau AM, Riordan NH.

ABSTRACT: Advancements in rheumatoid arthritis (RA) treatment protocols and introduction of targeted biological therapies have markedly improved patient outcomes, despite this, up to 50% of patients still fail to achieve a significant clinical response. In veterinary medicine, stem cell therapy in the form of autologous stromal vascular fraction (SVF) is an accepted therapeutic modality for degenerative conditions with 80% improvement and no serious treatment associated adverse events reported. Clinical translation of SVF therapy relies on confirmation of veterinary findings in targeted patient populations. Here we describe the rationale and preclinical data supporting the use of autologous SVF in treatment of RA, as well as provide 1, 3, 6, and 13 month safety outcomes in 13 RA patients treated with this approach.

PMID: 22313603 [PubMed – as supplied by publisher]

FULL TEXT: http://www.intarchmed.com/content/pdf/1755-7682-5-5.pdf

Medistem and Licensee ERCell Receive Russian Regulatory Approval for the RECOVER-ERC Trial

The clinical trial, Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy (RECOVER-ERC), is being led by Principle Investigator Dr. Leo Bockeria, Chairman of the Backulev Center http://www.bakulev.ru/en/about/director/.

The Backulev Center is Russia’s premier institute for cardiovascular surgery and cardiology. Every year the Backulev Center performs approximately 30,000 diagnostic and treatment procedures, which includes 7,000 open heart surgeries and more than 12,000 angioplasties.

The RECOVER-ERC trial will recruit 60 patients with congestive heart failure, and randomize the patients into 3 groups of 20 patients each. Group 1 will receive 50 million ERC, Group 2 will receive 100 million and Group 3 will receive 200 million. Each group will have 15 patients receiving cells and 5 patients receiving placebo. Efficacy endpoints include ECHO and MRI analysis, which will be conducted at 6 months after treatment.

“I joined Medistem and personally invested into the company because of its strong science and intellectual property position. It is this strong science that has allowed for such a rapid progression of the ERC product from discovery, to animal studies, and now to approval for initiation of efficacy finding studies,” said Dr. Vladimir Bogin, President and Chairman of Medistem, and a Yale-trained physician practicing in the USA. “As a medical doctor I see the suffering and lack of options for patients with CHF. I am proud that our team is able to offer hope.”

This is the second clinical trial that Medistem has been granted approvals for. In September 2011, the company received FDA clearance for beginning a 15 patient trial treating critical limb ischemia patients together with Dr. Michael Murphy at Indiana University.

“We are especially grateful to our Russian licensee ERCell LLC which has worked intensely with our CRO and the Backulev Center in laying down the groundwork for this approval,” said Vladimir Zaharchook, Vice President and Vice Chairman of Medistem. “To our knowledge, ERCell is the only company in Russia working on a stem cell product that can be reproducibly manufactured, frozen, and sold as a drug, not a procedure.”

“This approval is a key milestone for ERCell. Given that Russia has one of the highest incidences of heart failure per capita in the world, we are confident that we can make a difference in patients’ lives and position Russia as an international leader in cell therapy,” said Tereza Ustimova, CEO of ERCell.

About Medistem Inc.
Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company’s lead product, the endometrial regenerative cell (ERC), is a “universal donor” stem cell being developed for critical limb ischemia. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf. ERC can be purchased for scientific use through Medistem’s collaborator, General Biotechnology http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells.

Cautionary Statement
This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

Stem cells secrete factors that promote muscle growth after exercise

Stem cells that aid in healing disease and injury in skeletal muscle have been found inside muscles in greater numbers after exercise, according to a new animal study at the University of Illinois.

Just one exercise session increases the number of muscle-derived mesenchymal stem cells (mMSCs) in mice, according to Beckman Institute researcher Marni Boppart. Dr. Bopart is an assistant professor of kinesiology and community health at the University of Illinois.

mMSCs can differentiate (change) into many different cell types and are found throughout the body. For the first time, this study also showed that they also facilitate tissue healing indirectly.

Bopart said, “What we’ve been able to show in this paper and our current work is that mMSCs are not directly contributing to muscle growth, but do in fact secrete a variety of different factors that positively impact muscle growth.”

Bopart believes that these secreted factors, which specifically respond to mechanical strain are an important step toward treatments that can prevent muscle loss that occurs with aging.

This work was reported in the journal PlosOne.

Umbilical cord stem cells may lead to new spinal cord injury and multiple sclerosis treatments

Researchers in Florida have accomplished converting umbilical cord stem cells into other cell types. According to University of Central Florida bioengineer James Hickman, it’s the first time that non-embryonic cells have accomplished this feat. His research group published this work in the January 18th issue of ACS Chemical Neuroscience.

Two major benefits of umbilical cord-derived stem cells are that they have not been shown to cause adverse immune system reactions and they pose no ethical issues since they come from a source that would be naturally discarded anyway.

Hedvika Davis, a post-doc researcher and lead author of the paper, had to search for the right chemical to coax the stem cells into becoming oligodendrocytes, which are cells that insulate nerves residing in the brain and spinal cord.

Other researchers had already shown that oligodendrocytes bind with a hormone called norepinephrine and Davis theorized that this could be the key. So she used norepinephrine and other growth factors to induce the cells to differentiate into oligodendrocytes. The only problem was that the cells were not sufficiently developed as they would be in the body.

So Davis devised a novel approach of approximating the body’s environment in the lab. By growing the cells on top of a slide, with another slide on top, Davis was able to simulate a 3-dimensional environment and grow mature oligodendrocytes.

Because oligodendrocytes produce myelin, researcher believe that this discovery might lead to treatments for multiple sclerosis, spinal cord injury and diabetic neuropathy.

The Key to Better Health May Lie in Adult Stem Cells

One of the oldest people in the world, Sarah Knauss (119 years old), might have had more than just “good genes.” “Adult stem cells – known for their healing and regenerative properties – might hold the key to a long and healthy life,” says Wayne Marasco, MD, PhD, of Dana-Farber at the recent International Vatican Conference on Adult Stem Cells in Vatican City, Italy.

“We have learned in the past 10 years that there are all kinds of stem cells that circulate in the blood – they aren’t just found in bone marrow,” said Marasco, of Dana-Farber’s Department of Cancer Immunology and AIDS. “There are dozens of studies that support the fact that this is a large and dynamic population of cells that might help us keep our bodies healthy for a longer period of time.”

Stem cells are assigned to specialized zones in the body and called into action when the body faces stress or even a minor injury. For example, when someone has a heart attack or stroke, an agent is released into the blood, recruiting stem cells and directing them to the damaged tissue.

In addition to their healing powers, stem cell levels are also an indicator of future health. Studies have shown that a person’s level of endothelial progenitor cells, stem cells that form the tissues that line blood vessels, can predict whether or not a patient who has a heart attack will die or need major hospitalization.

Since stem cell levels can be modified through diet, lifestyle changes, or drugs, monitoring stem cells could prevent certain health risks and delay disease from occurring.

“The bottom line is that stem cells may be a better indicator of health and aging than the regular annual blood test, which was developed 50 years ago,” Marasco says. “Now that we know more about adult stem cells, this should be part of a routine test.”

Stem cell therapy may not be too far off in the future. Marasco says that doctors will soon be able to check stem cell levels in a drop of blood, using a finger-prick test much like those used by diabetics. Studies are also beginning to show the benefits of an FDA-approved molecule that improves the healing powers of stem cells, and the NIH has launched a new program that may lead to discoveries of already approved drugs that can boost adult stem cells.

“We can age gracefully, but we can also keep the body revitalized,” Marasco said. “The whole purpose of monitoring is to replenish our stem cells so that we can get more healthy years out of them.”