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

Quality time: Former Ennis coach Sam Harrell is counting his blessings despite having multiple sclerosis

ENNIS, TX — Sam Harrell’s three state football championships are celebrated in his home office. He has pictures, trophies and balls, and even more memories.

For 32 years, Harrell worked in a profession where success is measured by a scoreboard in front of thousands.

These days, life’s little victories — unaccompanied by cheers or Gatorade showers — are just as satisfying.

Harrell can jump up and down in his living room. He can walk across a parking lot without a cane or a walker. He can spend hours at Kolache Depot Bakery without getting fatigued.

Harrell hasn’t beaten multiple sclerosis, but he is successfully living with it.

“It puts everything in perspective,” Harrell said. “Now, I’d rather play catch with my grandson in the back yard than win a state championship. When that gets taken away from you, you realize how precious it is.”

Harrell was 153-51 in 16 seasons at Ennis, winning Class 4A state titles in 2000, ’01 and ’04. He coached all three of his sons — Graham, now a backup quarterback with the Green Bay Packers; Zac, the offensive coordinator at Van High School; and Clark, who finished his college career at Abilene Christian in 2010 and now works as a financial planner.

It was in 2005, while he was on the tennis court, that Harrell’s vision in one eye became blurry. An eye specialist sent him to a neurologist, who, after running tests, gave Harrell the best possible diagnosis: He had MS.

“I didn’t know whether I was supposed to cheer or cry,” Harrell said. “I got the best of the three things it could be, but the bad news is: I have MS.”

Multiple sclerosis is a chronic, unpredictable disease that affects the central nervous system. The immune system eats away the myelin sheath surrounding the nerves. Symptoms vary from person to person. Mild symptoms include numbness in the limbs, weakness, fatigue and blurred vision. Severe symptoms include paralysis and loss of vision.

There is no known cure for MS.

Harrell chose to keep the news a secret from everyone except his wife, Kathy. He didn’t reveal the diagnosis for four years, though, as his condition worsened, those close to Harrell knew something was wrong.

“We’d go to practice, and he had to take a golf cart,” Graham Harrell said in a phone interview after a recent Packers practice. “Sometimes he was off balance a little bit, or shaky walking. So there were times we knew something wasn’t quite right, but we didn’t know exactly what was going on until he finally told us.

“It was hard to watch, obviously, especially with him wanting to coach, and yet not being able to do it like he used to. But recently, he’s seen great improvement, and that’s huge encouragement not only to him, but to us, and hopefully he’ll continue to get better.”

Sam Harrell knew his MS wouldn’t kill him, but he thought not coaching might.

Sam’s father, Jake, established the family business at Seminole, where he spent 20 seasons, including 10 as the head coach. But Sam Harrell’s health forced him to quit coaching before the 2010 season.

“That’s all I’d done my whole life,” Harrell said, “so I was sick about it. I just didn’t know what I was going to do.

“I do wish I could still do it, but I haven’t died from not coaching.”

Harrell, in fact, is alive and well. He credits three trips to Panama for his improved health.

After he retired from coaching, Harrell began researching regenerative medicine. Stem cell treatment is not approved in the United States, but Dr. Neil Riordan, who lives in Trophy Club, is the founder of the Stem Cell Institute in Panama.

Riordan is one of the leading stem cell scientists in the world.

Harrell talked to several of Riordan’s patients, including Richard Humphries, a golf coach out of Diamond Oaks Country Club in Fort Worth. Humphries was diagnosed with MS in 2005. He began stem cell treatments in 2008.

Stem cell treatments introduce new cells, which have regenerative potential, into damaged tissue to treat disease or injury.

“After talking to Richard, I didn’t have the money, but I knew I was going to go,” Harrell said. “I mean, what did I have to lose? I knew where I was headed if I didn’t go. I was going downhill fast. So why wouldn’t I go try this?”

Friends, family and fellow coaches held fundraisers for Harrell’s treatments. Harrell’s first trip to Panama, which was four weeks, cost $40,000. He has been back twice more, the last time in September.

It wasn’t until the third visit that Harrell saw dramatic results.

“MS is like a two-hump camel,” Humphries said. “You can get over the first hump of active T-Cells fairly easily, but the second hump, the memory T-Cells, sometimes bring our MS symptoms back, as it did with Sam.

“He was extremely disappointed for taking the two steps back after three steps forward. I told him it may take another two or three treatments to really get you going again. Needless to say, he could not stop smiling and was greatly relieved. Now, he is seeing the results.”

Harrell is a strong Christian and is quick to credit God and prayer for his recovery. But he also is a big believer in stem cell therapy. Kathy Harrell is a more recent convert.

She was skeptical until seeing the change in Harrell.

“I just feel really grateful that these are good days and good months, and I’m not going to worry about next year,” Kathy Harrell said. “It just makes you thankful that things are good right now, and he’s pretty mobile. This disease reminds you to just be thankful for the day, so that’s what we’re doing. I realize now it can be worse.”

By Charean Williams

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.”

First patient to get stem cell therapy identified

By Rob Stein, The Washington Post
Embryonic stem cells have numerous pitfalls in addition to the ethical dilemmas. While the concept of a “blank slate” cell is extremely attractive in terms of generating new tissues for transplantation and organ replacement, the problem is that these cells are so young that they do not properly “know” how to integrate with existing tissues. This causes the problem of possible dysfunction of the cellular products made from the cells, but also causes the issue of cancer formation. Many studies have demonstrated that administration of embryonic stem cells, or products made from them form cancers when injected into mice that lack an immune system.
Because of the risks associated with embryonic stem cells, the FDA has been historically reluctant to allow initiation of clinical trials with them. The leader of the field of embryonic stem cells is Geron, the company that funded the research that lead to the discovery of human embryonic stem cells, as well as the company that has the exclusive license for their commercial use. The business of embryonic stem cells is associated with large financial investments. Specifically, patents are not only associated with the cells themselves but one methods of growing the cells and methods of selecting the cells to reduce the possibility of cancer formation. In some ways people believe that embryonic stem cells are an exercise in science because adult stem cells have been demonstrated to elicit numerous therapeutic effects without the risks.
Last year a monumental study was initiated in that the FDA allowed for the first human use of an embryonic stem cell product. The company Geron was granted approval to treat patients with spinal cord injury using embryonic stem cell derived oligodendrocytes, the cells that generate the myelin that lines the nerves.
Today, information was released on the first patient that was treated with these cells. The patient was a partially paralyzed young man, Timothy J. Atchison, 21, known to family and friends as T.J.
T.J. was a student at the University of Alabama College of Nursing when he was partially paralyzed in a Sept. 25 car accident, his aunt and father said. He agreed to let doctors infuse more than 2 million cells made from stem cells into his spine 13 days later at the Shepherd Center in Atlanta, according to his aunt and a family friend.
While the primary endpoint of the trial is to demonstrate safety, doctors are also testing whether the cells restore sensation and movement. It was too soon to tell whether the cells were helping T.J., Angela Atchison said. “They said it would be about a year before they’ll know if there’s any difference — if it takes,” she said. “We’re just hoping and praying that it works.”
T.J.’s father, Timothy Atchison of Millry, said his son had maintained a positive attitude, beginning when he was in the emergency room after the accident. and understood how seriously he was injured.
“He said, whatever the Lord leaves him with, he’ll do the best he can with it,” the father said in a phone interview Monday. He would not directly acknowledge that his son was in the stem cell study, but confirmed details including his Shepherd Center treatment. “I’ll put it this way, they tested a lot of folks, and only one made the cut,” he said during another interview Tuesday. “You can read between the lines.”

“The fight to walk” – spinal cord injury patient improving after stem cell therapy in Panama

Daniel-Leonard-1-StemCell

Daniel Leonard working out at physical therapy

Published March 31, 2012
By Sue Guinn Legg – Press Staff Writer

Daniel Leonard is doing all he can to walk again, and after a recent course of stem cell treatment he’s as close as he has been since a few months after the 2005 injury that put him a wheelchair.

He was 22 years old and about to begin his third year of college when he woke up one August morning on the floor at his family’s Johnson City home unable to move and struggling to breathe.

While the cause of his injury remains a mystery, what is known is that three vertebrae near the top of his spine had been crushed, leaving him paralyzed from the neck down, on a ventilator and not expected to never walk or even breathe on his own again.

Six months after undergoing surgery to remove the bone fragments from his spinal cord, Leonard, who had played several sports in high school and was boxing at the Johnson City Athletic club prior to his injury, was exceeding all expectations.

In treatment at the Patricia Neal Rehabilitation Center in Knoxville, he was not only breathing independently, he was pulling himself up on parallel bars and being fitted with leg braces to help him take his first steps.

Then the unthinkable happed, again. Because there had been nothing done to stabilize his damaged vertebrae, his spine collapsed at the site of his injury and all of his progress was lost.

“I worked my butt off to get to the point I was about to start walking,” he said. But the gains he had made in upper body strength were erased and there was no longer any movement in his legs.

After a second surgery to fuse the bones, his condition was labeled as “incomplete paraplegia” characterized by limited movement and sensation in all the muscles below his neck and none at all in his legs. Doctors told his family he would never be able to move his legs, and for many years he could not.

For a while, he lived independently with the assistance of a caregiver. When his caregiver left, he moved to a nursing home, expecting to stay only long enough to find another place and another caregiver. But without money to finance that plan, months turned into years and the Four Oaks Health Care Center in Jonesborough became his home for the long term.

Early last year, things took a turn for the better when for reasons unknown he began to regain some movement in his legs. Encouraged, Leonard once again threw all his effort into physical therapy. In October, he began working out regularly with Amy Caperton, a personal trainer at the Tri-Cities Lifestyles fitness center in Johnson City, and coupled that with physical therapy at the new Mountain States Rehabilitation Center.

His family, who had long believed stem cell treatment would provide his best chance at recovery, stepped up their efforts to pay for the treatment.

His sister, Rachael Leonard, a business consultant who had been following the progress of stem cell research and exploring treatment options since a few days after Daniel was injured, zeroed in on The Stem Cell Institute, a reputable facility in Panama founded by Neil Riordan PhD, that concentrates on treatment of spinal cord injuries, muscular sclerosis, rheumatoid arthritis and heart disease.

His mother and siblings pooled their resources and came up with about half the $45,000 needed for the $35,000 cost of his first four-week course of treatment and travel expenses for Daniel, Rachel and their mother, Diane, to make the trip to Panama.

The balance was raised through a series of small benefits — dinners at area restaurants, a concert and an auction, and through many individual gifts and online contributions to Daniel’s fundraising page, www.givefoward.com/danielleonardstemcells.

“People we know around here and businesses were very generous and there was a lot of money raised,” his mother said.

To clear up any misconceptions about the treatment, the family emphasized to everyone interested that the stem cells used at the institute come from umbilical cords donated by new parents and the patients’ own bone marrow and referred them to www.cellmedicine.com for specifics.

“I’m not trying to tell people what to do with their own bodies, but for me, if it had been kill a baby to walk again, there’s no way I would have,” Daniel Leonard said.

The family finally made it to Panama in February. The treatment began with two weeks of daily cord blood cell injections into his spinal fluid and two hours of “intense interval” therapy that requires Leonard to work his muscles as hard as possible for one minute, rest for two minutes and repeat the process over the course of an hour.

“One hour is what they do, but with what I had been doing with Amy already, I thought I needed more,” he said.

The injections were painful and the workouts exhausting, so Leonard was relieved when Panama’s annual carnival week celebration gave him a week of rest before the treatment resumed with another two weeks of daily injections of cells drawn from his hip bones.

On the second day of his fourth week of treatment, Leonard experienced his first noticeable improvement when he flexed the right calf muscle he had not been able to move in years. The following day he felt himself contracting the pectoral muscles in his chest.

Day by day he’s regaining strength and there have been many small, but encouraging, gains that have also been obvious to caregivers. At Four Oaks, his aides are changing the way they handle things. While transferring Leonard from bed to a chair, it’s easier for them to raise him to his feet to pivot, which can now be done with one person’s assistance rather than two.

“These are all little things, but they are huge for us,” Leonard said.

Caperton, who with help from a client at Lifestyles spent a few days in Panama learning all she could from doctors and therapists at the institute, is equally encouraged.

“I am trying to be objective, but I must say he is making drastic improvements and it excites me,” she said.

The next six months before the stem cells die hold Leonard’s greatest opportunity for improvement, and continuing his physical training will play a critical role in the treatment’s effectiveness.

Optimum recovery will come with repeat treatments, and the fundraising for Leonard’s next trip to Panama is under way. There’s a three-on-three basketball tourney being planned at the Lifestyles center, and Leonard is searching for a local business to put up a prize worthy of the tournament’s entry fee.

He’s inviting everyone to follow his progress at his Facebook page, Daniel Leonard Search for a Cure (http://on.fb.me/H6sAtf). And for anyone who wishes to help, online donations may be made at www.giveforward.com/daniellenoardstemcells.

Donations to the “Daniel Leonard Search for a Cure Fund” can also be made at any First Tennessee Bank location or by mail to First Tennessee Bank, 1500 W. State of Franklin Road, Johnson City, TN 37604.

“Hopefully, with the next treatment I’ll be able to stand,” he said. “I’m excited about it. I can’t wait to see the results.”

Great Day in Ft. Worth for Stem Cell Team

Stem cell patients and MS walk in Fort Worth

Stem Cell Institute patients participate in MS Walk 2012

Saturday, March 31 was the annual MS Walk in Ft Worth. This year, thanks to the Stem Cell Institute and some of the area stem cell patients, several of us MS sufferers and stem cell patients met for the Walk. Here’s a picture of several of us who have been to Panama, or Costa Rica, for treatments – (from L – R) Richard, Carolyn, Shelley, Carla, Judi, Holly, and me.

We wanted to give the Stem Cell Institute a presence in that sea of MS victims and caregivers. I wish all of them knew that many of us in those blue t-shirts were there walking, actually completing the whole mile, even though we were once unable to do such. I wanted to grab that microphone that the organizers were using and tell all of them “There is HOPE – it doesn’t have to be what you hear from your doctors so often. It can be more than ‘Let’s keep taking this medication so you might get worse at a slower rate’ ”

I personally never heard about the possibility of actually improving when I went to good doctors here in the US – but I chose to try the Stem Cell treatment in Panama, and I walked that mile on Saturday! A year ago, six months ago, I couldn’t have done that – but after my third trip to Panama in September, my walking, my balance, and my stamina all improved dramatically. And many of those in our group on Saturday have a similar story; some results more dramatic than others, but most all of us have seen and felt the changes that give us that Hope that all of those sufferers at the Walk are looking for.

THANKS STEM CELL INSTITUTE!

Sam Harrell
Sam in Panama

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

Stemedica Treats First Patient with Ischemic Allogeneic Mesenchymal Stem Cells

Stemedica Cell Technologies Press Release
The San Diego stem cell company Stemedica Cell Technologies, Inc reported treatment of its first patient as part of a 35 patient clinical trial in stroke patients. The study uses bone marrow stem cells that have been preconditioned with hypoxia and used in a non-matched manner. The trial is being conducted at the University of California San Diego and is titled “A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke.”
Every year more than 800,000 Americans suffer a stroke. According to the American Heart Association, stroke is the fourth leading cause of death – costing an estimated $73.7 billion in 2010 for stroke-related medical costs and disability.
The study’s Principle investigator is Michael Levy, MD, PhD, FACS, chief of pediatric neurosurgery at Children’s Hospital San Diego (CHSD) and professor of neurological surgery at UCSD. The aim of the trial is to determine tolerance and therapeutic outcomes for intravenously-delivered adult allogeneic mesenchymal stem cells and to hopefully pave the way for a new therapeutic category of treatment for ischemic stroke. When asked about the first patient in the study, Dr. Levy said, “The treatment went smoothly; no side effects were observed, and the patient was released from the hospital the next day.”
Lev Verkh, PhD, Stemedica’s chief regulatory and clinical development officer, commented: “Many years of research and hard work by the Stemedica team culminated today in the treatment of the first patient using our uniquely designed stem cells to be effective under ischemic condition. We are proud to be the first company to initiate a study such as this under a clinical protocol approved by the U.S. Food and Drug Administration (FDA).”
Several companies are using stem cells for stroke. For example the company Aldagen is using bone marrow derived cells from the same patient. Their approach involves bone marrow extraction, purification of a selected stem cell from the bone marrow, and subsequent administration of the cell into the patients. The reason why stroke is of great interest to many companies is because recent studies have demonstrated that the brain has its own stem cells that start multiplying after a stroke. Unfortunately these stem cells that are already existing are not found in a high enough number to cause a substantial repair. The idea is that when new stem cells are added, they assist the existing stem cells in supporting the repair process.
“This clinical trial marks a significant achievement in the treatment of debilitating ischemia-related pathologies including ischemic stroke,” said Nikolai Tankovich, MD, PhD, president and chief medical officer of Stemedica. “We believe these specially designed mesenchymal stem cells are able to tolerate, survive and repair ischemic tissues caused by an infarction of the brain, heart, kidney, retina and other organs. In addition, these mesenchymal stem cells are capable of up regulating an array of important genes that are essential for the synthesis of critical proteins involved in recovery.”
Dr. Verkh continued, “Patients in this study have significant functional or neurologic impairment that confines them to a wheelchair or requires home nursing care or assistance with the general activities of daily living and have received the ischemic stroke diagnosis at least six months prior to enrollment in this study”.
The inclusion/exclusion criteria are:
Inclusion Criteria:
•Clinical diagnosis of ischemic stroke for longer than 6 months
•Brain CT/MRI scan at initial diagnosis and at enrollment consistent with ischemic stroke
•No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment
•NIHSS score between 6-20
•Life expectancy greater than 12 months
•Prior to treatment patient received standard medical care for the secondary prevention of ischemic stroke
•Adequate organ function as defined by the following criteria:
Exclusion Criteria:
•History of uncontrolled seizure disorder
•History of cancer within the past 5 years.
•History of cerebral neoplasm
•Positive for hepatitis B, C or HIV
•Myocardial infarction withing six months of study entry
•Findings on baseline CT suggestive of subarachnoid or intracerebral hemorrhage within past 12 months.
•Allergies to Bovine or Porcine products

Medistem Signs Exclusive Worldwide License With Yale University for Treatment of Type 1 Diabetes Using Stem Cells

Acquisition of Intellectual Property and Data Leads to Expansion of Medistem Therapeutic Pipeline

SAN DIEGO, CA, Mar 07, 2012 (MARKETWIRE via COMTEX) — Medistem Inc. (pinksheets:MEDS) and Yale University have signed an exclusive worldwide licensing agreement covering the generation of pancreatic islets from stem cells such as the Endometrial Regenerative Cell (ERC). These pancreatic islets have effectively treated diabetes in animal models.

Professor Hugh Taylor of Yale University, inventor of the technology, made international headlines in September 2011 when he published his findings in the peer-reviewed journal Molecular Therapy.

“Medistem is the first company to develop clinical-grade endometrial-derived stem cells and initiate trials in humans,” said Professor Taylor. “Since Medistem’s Endometrial Regenerative Cells are manufactured inexpensively, can be used as an ‘off the shelf’ product, and to date appear safe in human subjects, I am very excited to see diabetes added to the list of diseases that can potentially be treated with Medistem’s ERCs.”

Medistem is currently in two clinical trials with ERCs: One for critical limb ischemia and a second for congestive heart failure, both of which are complications of uncontrolled diabetes.

“Type 1 diabetes is a rapidly growing poorly-served market. There is great optimism that cell-based therapies can address not only pancreatic degeneration but also the underlying immunological causes,” said Dr. Alan Lewis, former CEO of the Juvenile Diabetes Research Foundation, the largest non-profit organization focused on development of new therapeutic approaches for this disease. “The ERC is the newest adult stem cell to enter clinical trials. Based on this unique source of cells, as well as their immune modulatory properties, we believe this work may be expanded into other autoimmune diseases.”

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 and congestive heart failure. 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.