Wichita, KS (PRWEB) September 10, 2014

Ryan Benton, a 28 year-old Duchennes muscular dystrophy patient from Wichita, Kansas, received his first umbilical cord tissue-derived mesenchymal stem cell treatment yesterday following US FDA approval of his doctors application for a single patient, investigational new drug (IND) for compassionate use.

Duchenne muscular dystrophy (DMD) is a rapidly progressive form of muscular dystrophy that occurs primarily in boys. It is caused by an alteration (mutation) in a gene, called the DMD gene, which causes the muscles to stop producing the protein dystrophin. Individuals who have DMD experience progressive loss of muscle function and weakness, which begins in the lower limbs and leads to progressively worsening disability. Death usually occurs by age 25, typically from lung disorders. There is no known cure for DMD.

This trial, officially entitled Allogeneic transplantation of human umbilical cord mesenchymal stem cells (UC-MSC) for a single male patient with Duchenne Muscular Dystrophy (DMD) marks the first time the FDA has approved an investigational allogeneic stem cell treatment for Duchennes in the United States.

Ryan received his first intramuscular stem cell injections from allergy and immunology specialist, Van Strickland, M.D at Asthma and Allergy Specialists in Wichita, Kansas. He will receive 3 more treatments this week on consecutive days. Dr. Strickland will administer similar courses to Ryan every 6 months for a total of 3 years.

This is not the first time Ryan has undergone umbilical cord mesenchymal stem cell therapy. Since 2009, Ryan has been traveling to the Stem Cell Institute in Panama for similar treatments. Encouraging results from these treatments prompted Dr. Strickland to seek out a way to treat Ryan in the United States.

The stem cell technology being utilized in this trial was developed by renowned stem cell scientist Neil H. Riordan, PhD. Dr. Riordan is the founder and president of the Stem Cell Institute in Panama City, Panama and Medistem Panama. Medistem Panama is providing cell harvesting and banking services for their US-based cGMP laboratory partner.

Funding for this trial is being provided by the Aidan Foundation, a non-profit organization founded by Dr. Riordan in 2004 to provide financial assistance for alternative therapies to people like Ryan.

About Van Strickland, MD

Dr. Strickland came to Wichita in 1979 from his fellowship at the National Jewish Hospital in Denver. Since then he has spent one year in Wyoming, one year in Dallas, Texas and one year in Lees Summit Missouri before returning to full-time practice in Wichita, Kansas.

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After FDA Approval, Duchennes Muscular Dystrophy Patient Receives First Umbilical Cord Stem Cell Treatment in the ...

Spinal Cord Injury

Damage to the spinal cord usually results in impairments or loss of muscle movement, muscle control, sensation and body system control.

Presently, post-accident care for those who suffer spinal cord injuries focuses on extensive physical therapy, occupational therapy, and other rehabilitation therapies; teaching the injured person how to cope with their disability.

A number of published papers and case studies support the feasibility of treating spinal cord injury with allogeneic human umbilical cord tissue-derived stem cells and autologous bone marrow-derived stem cells.

Feasibility of combination allogeneic stem cell therapy for spinal cord injury: a case report co-authored by Stem Cell Institute Founder Dr. Neil Riordan references many of them. Published improvements include improved ASIA scores, improved bladder and/or bowel function, recovered sexual function, and increased muscle control.

The adult stem cells used in spinal cord injury investigational treatments at the Stem Cell Institute come from two sources: the subjects own bone marrow (autologous mesenchymal and CD34+) and human umbilical cord tissue (allogeneic mesenchymal).

A licensed anesthesiologist harvests bone marrow from both hips under light general anesthesia in a hospital operating room. This procedure takes about 1 1/2 2 hours. Before they are administered to the subject, these bone marrow-derived stem cells must pass testing for quality, bacterial contamination (aerobic and anaerobic) and endotoxin.

All donated umbilical cords are screened for viruses and bacteria to International Blood Bank Standards.

Our stem cell clinical protocol for spinal cord injury calls for a total of 16 injections over the course of 4 weeks.

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Stem Cell Therapy || Spinal Cord Injury || Investigational ...

Scientific publications from PubMed.gov

PubMed comprises more than 23 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Regen Med. 2013 May;8(3):271-81 Authors: Ning G, Tang L, Wu Q, Li Y, Li Y, Zhang C, Feng S

Abstract AIM: We aim to explore the repair mechanism after the transplantation of CD34(+) human umbilical cord blood cells (HUCBCs) in traumatic spinal cord injury (SCI) in rats.

MATERIALS & METHODS: Wistar rats with SCI were randomly divided into three groups: DMEM injection (group A); CD34(+) HUCBC transplantation on the first day after injury (group B); and CD34(+) HUCBC transplantation on the sixth day after injury (group C). The Basso, Beattie and Bresnahan scores were used to evaluate motor behavior. At the injured site, the infarct size, blood vessel density, and survival and neural differentiation of transplanted cells were analyzed.

RESULTS: It was found that the Basso, Beattie and Bresnahan score in group B was significantly higher than other groups (p < 0.05), and the infarct size and blood vessel density at the injured site were significantly different (p < 0.01). However, the transplanted cells survived at least 3 weeks at the injured site, but did not differentiate into neural cells.

CONCLUSION: These results suggested transplantation of CD34(+) HUCBCs during the acute phase could promote the functional recovery better than during the subacute phase after SCI by raising blood vessel density, suggesting the possible clinical application for the treatment of spinal injury.

PMID: 23627822 [PubMed - indexed for MEDLINE]

Cytotherapy. 2013 Feb;15(2):185-91 Authors: Liu J, Han D, Wang Z, Xue M, Zhu L, Yan H, Zheng X, Guo Z, Wang H

Abstract BACKGROUND AIMS: The purpose of this study was to observe the clinical effect and safety of umbilical cord mesenchymal stem cells (UC-MSCs) in treating spinal cord injury (SCI) by intrathecal injection.

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Spinal cord injury and stem cell publications

By RTT News, August 27, 2014, 06:53:00 AM EDT

(RTTNews.com) - Asterias Biotherapeutics Inc. (ASTY.OB) said Wednesday that it has received clearance from the U.S. Food and Drug Administration or FDA to initiate a Phase 1/2a clinical trial of its product, AST-OPC1, in patients with complete cervical spinal cord injury.

The company stated that the approved trial follows the successful completion of the Phase 1 clinical study of the product, and is designed to assess safety and activity of escalating doses of AST-OPC1 in patients with complete cervical spinal cord injuries, the first targeted indication for AST-OPC1 and the first of future product registration clinical trials.

AST-OPC1 is a population of cells derived from human embryonic stem cells (hESCs) that contains oligodendrocyte progenitor cells (OPCs). OPCs and oligodendrocytes perform supportive functions for nerve cells in the central nervous system. The foundation for this newly cleared Phase 1/2a clinical trial comes from results from the Phase 1 clinical trial of AST-OPC1, which met its primary endpoints of safety and feasibility when administered to five patients with neurologically-complete, thoracic spinal cord injury.

These five patients were administered a low dose of two million AST-OPC1 cells and have been followed to date for 2 to 3 years. No serious adverse events were observed associated with the delivery of the cells, the cells themselves, or the short-course immunosuppression regimen used.

The company noted that the new Phase 1/2a clinical trial will be an open-label, single-arm study testing three escalating doses of AST-OPC1 in 13 patients with subacute, C5-C7, neurologically-complete cervical spinal cord injury. These individuals have essentially lost all sensation and movement below their injury site with severe paralysis of the upper and lower limbs.

AST-OPC1 will be administered 14 to 30 days post-injury. Patients will be followed by neurological exams to assess the safety and activity of the product. Selection of the clinical trial sites is well underway and the Company expects to begin patient enrollment during the first quarter of 2015.

The new clinical trial differs from the original clinical study in that doses up to 10 times higher will be tested. In addition, the trial will focus on patients with neurologically-complete cervical spinal cord injuries. Because of the anatomy of the spinal cord and the existence of more sensitive outcomes measures to assess movement of the arms and hands, it is currently believed that detection of efficacy is much more likely to occur in patients with cervical injuries. It is this patient population that Asterias anticipates will be the target for the first registration clinical trials of AST-OPC1.

The results of the Phase 1/2a clinical trial are expected to provide support for a Phase 2b expansion study that will be conducted to more thoroughly demonstrate safety and efficacy of the product.

For comments and feedback: contact editorial@rttnews.com

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Asterias Gets FDA Clearance To Initiate Phase 1/2a Trial Of AST-OPC1

Manila:

A Philippine Catholic bishop Wednesday urged donors to research on Lou Gehrigs Disease to ensure that their money does not go to unethical studies involving stem cells.

The pastoral guidance was issued as more Filipinos take part in the viral fundraising ice bucket challenge for Lou Gehrigs Disease or Amyotrophic Lateral Sclerosis (ALS), a degenerative disease that affects nerve cells in the brain and spinal cord.

Archbishop Socrates Villegas said donors must make a clear and unequivocal declaration that their donation is made on condition that none of it is applied to research that involves the use of embryonic stem cells in vitro. Catholics who participate in the challenge and who make donations to this research must also demand of fund-raisers and organizers an assurance that none of the donations made will be applied to researches that are ethically reproved, he added.

Villegas said that as long as the research was ethical, the Church would even encourage Catholics to donate, noting, The importance of ALS research cannot be overstated. Research must proceed, for so many suffer. Several top government officials, business leaders and other Filipino personalities have recently taken up the ALS ice bucket challenge, drenching themselves in cold water to raise money for research on the illness.

(This article was published on August 27, 2014)

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Filipino bishop urges donors not to support stem cell research

Last week I discussed the current state of stem cell research and the sociopolitical situation surrounding it. As with any controversial or complex subject being shared with the neophyte it is pointless without a physical, material context to put it in. Many people simply don't know something because it doesn't pertain to them. No-one wants to think about disease, let alone talk about it... why in the world would anyone want to research it? I learned very early on in my injury not to hold others accountable for what they do not fully understand. So much of suffering is purely subjective and experiential, how could they possible grasp what I'M feeling? Or vice versa for that matter? That said, ask yourself, why else would I study any kind of infirmity unless I a. had it, or b. was a doctor? This posting will be to inform those of you who do not understand how spinal cord injury happens and the results it can have. It should help you get a stronger grasp on why stem cells are such an interesting possibility.

Spinal cord injury is one of the least understood conditions on the planet. There are approximately 450,000 spinal cord injury survivors in the United States. Compare that to the millions of cancer patients or those with heart disease. It is simply rare. Every spinal cord injury is different, like a finger print. There are thousands of nerves in the spinal cord, one can be damaged or all of them, or none at all. Consider for a moment what the spinal cord is, in the words of Wikipedia...

It gets even more complicated still. There are levels of spinal cord injury. The vertebrae of the spine which becomes injured determines the type or "level" of injury. The cervical spine down to the upper thoracic is classified as Quadriplegia or Tetraplegia the lower you go. Once the injury drops below the third or fourth thoracic vertebrae it becomes Paraplegia.

Clearly we can now see how treating spinal cord injury generally must be done on a case by case basis. When you factor in age, weight, age of injury, lifestyle and amount of therapy it becomes even more complex. Up until now the real treatment has been in progressive physical therapy. The best centers are those who focus solely on rehabilitating injuries to the central nervous system. We can narrow that category down further to those who are committed to continuous movement towards a cure and taking your treatment into your own hands. These facilities are spread throughout the country on such a minimal level many patients devote their entire lives to the cycle of raising money and traveling just for a few days a month, or even a year, to get the level of care they need. Keep in mind the insurance companies will rarely cover even the cost of therapy, let alone travel.

Things are changing however. There is a grassroots movement in medicine that holds exciting promise. I am going to wrap up this portion of the discussion, but next week I'll continue with more on this movement on the horizon, what living with SCI is like and why there is hope in stem cells. Tune in...

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The Stem Cell: Understanding Spinal Cord Injury: Part 1

Stem Cells and Spinal Cord Injury:

Spinal cord injuries are described at various levels of "incomplete", which can vary from having no effect on the patient to a "complete" injury which means a total loss of function.

Treatment of spinal cord injuries starts with restraining the spine and controlling inflammation to prevent further damage. The actual treatment can vary widely depending on the location and extent of the injury. In many cases, spinal cord injuries require substantial physical therapy and rehabilitation, especially if the patient's injury interferes with activities of daily life.

After a spinal cord injury, many of the nerve fibers at the injury site lose their insulating layer of myelin. As a result, the fibers are no longer able to properly transmit signals between the brain and the spinal cord contributing to paralysis. Unfortunately, the spinal cord lacks the ability to restore these lost myelin-forming cells after trauma.

Tissue engineering in the spinal cord involves the implantation of scaffold material to guide cell placement and foster cell development. These scaffolds can also be used to deliver stem cells at the site of injury and maximize their regenerative potential.

When the spinal cord is damagedeither accidentally (car accidents, falls) or as the result of a disease (multiple sclerosis, infections, tumors, severe forms of spinal bifida, etc.)it can result in the loss of sensation and mobility and even in complete paralysis.

Spinal Cord Injury and Stem Cell Treatment

Adult stem cell transplants for spinal cord injury repair: current state in preclinical research.

Hernndeza J, Torres-Espna A, Navarro X.

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Spinal Cord Injury Stem Cell Treatment - ASCI - Stem Cell ...

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Researchers from Rochester, N.Y., and Colorado have revealed that manipulating stem cells prior to transplantation may lead to improved spinal cord repair methods. When nerve fibers are injured in the spinal cord, the severed ends of the nerve fibers fail to regenerate and reconnect with the nervous system circuitry beyond the site of the injury. During early development, the astrocytes cells of the brain and spine are highly supportive of nerve fiber growth, and scientists believe that if properly directed, these cells could play a key role in regenerating damaged nerves in the spinal cord. Rather than transplanting naive stem cells, the team has adopted an approach of pre-differentiating stem cells into better-defined populations of these brain cells. These stem cells are then selected for their ability to promote recovery.

Researchers from Rochester, N.Y., and Colorado have revealed that manipulating stem cells prior to transplantation may lead to improved spinal cord repair methods. When nerve fibers are injured in the spinal cord, the severed ends of the nerve fibers fail to regenerate and reconnect with the nervous system circuitry beyond the site of the injury. During early development, the astrocytes cells of the brain and spine are highly supportive of nerve fiber growth, and scientists believe that if properly directed, these cells could play a key role in regenerating damaged nerves in the spinal cord. Rather than transplanting naive stem cells, the team has adopted an approach of pre-differentiating stem cells into better-defined populations of these brain cells. These stem cells are then selected for their ability to promote recovery.

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Stem Cell Breakthrough in Spinal Cord Injury Repair

Because the ALS Association supports stem-cell research.

The Ice Bucket Challenge has been the biggest viral-charity sensation of the year, and maybe ever reaching its cold, wet arms all the way to George W. Bush and Anna Wintour, and raising millions of dollars for ALS research along with providing an immaculate blooper reel.

But one group is not pleased by all your Facebook videos: anti-abortion activists, who are mad that the ALS Association gives money to a group that supports stem-cell research.

"Attention pro-lifers: be careful where you send your ALS Ice Bucket Challenge donation," blared a headline on LifeNews.com earlier this week. The article explained that the ALS Association, one of the charities receiving ice-bucket donations, gave $500,000 last year to the Northeast ALS Consortium, which in turn had been affiliated with a clinical trial that used "stem cells ... engineered from the spinal cord of a single fetus electively aborted after eight weeks of gestation. The tissue was obtained with the mothers consent."

"Of course the fetus, from whom the 'tissue' was taken, did not 'give consent,'" LifeNews.com wrote. "So if you give to the ALS Association your money may end up supporting clinical trials that use aborted fetal cells."

Following the report, the Cincinnati Archdiocese warned Catholic school principals not to send donations to the ALS Association, andsome anti-abortion activists have begun making their own "pro-life Ice Bucket Challenge" videos.

CBN News, the Christian TV channel that broadcasts Pat Robertson's 700 Club, put a video of its Ice Bucket Challenge on Facebook, but not without informing its audience that the donations from the challenge would go to "an organization that does not support or use embryonic stem cell research."

Meanwhile, a 2013 FDA-approved study using human stem cells resulted in slowing the progression of ALS to an "extraordinary" degree.

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Anti-Abortion Activists Are Doing Their Own Ice Bucket Challenges

The UC San Diego Health System put out a call Monday for eight spinal cord injury patients to take part in a five-year test of the safety of a new treatment involving neural stem cells.

The researchers are looking for people who suffered an injury to the middle or lower levels of the spine's thoracic vertebrae between one and two years ago. According to UCSD, the injury must be between the seventh and 12th thoracic vertebrae.

"The goal of this study is to evaluate the safety of transplanting neural stem cells into the spine for what one day could be a treatment for spinal cord injuries," said Dr. Joseph Ciacci, the study's principal investigator and a neurosurgeon at UC San Diego Health System. "The study's immediate goal, however, is to determine whether injecting these neural stem cells into the spine of patients with spinal cord injury is safe."

The doctors also want to know how long the transplanted stem cells will last, and whether drugs designed to prevent rejection by the immune system are effective, according to UCSD Health.

The researchers will also look for possible changes in motor and sensory function, bowel and bladder function, and pain levels.

The stem cells were tested in laboratory rats by Ciacci and Dr. Martin Marsala, of the UC San Diego School of Medicine. They detected signs of improved motor function with minimal side effects. The cells have also been tested for safety in human patients with amyotrophic lateral sclerosis commonly known as ALS or Lou Gehrig's Disease.

UCSD cautioned prospective test subjects that since human tests are just beginning, unforeseen risks, complications or unpredictable outcomes are possible.

The clinical trial at UC San Diego Health System is funded by Neuralstem Inc. and was launched and supported by the UC San Diego Sanford Stem Cell Clinical Center. The center was recently created to "advance leading-edge stem cell medicine and science, protect and counsel patients, and accelerate innovative stem cell research into patient diagnostics and therapy," according to UCSD.

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UCSD Looking For Spinal Cord Injury Patients To Test Stem Cell Treatment

SAN DIEGO (CNS) - The UC San Diego Health System put out a call Monday for eight spinal cord injury patients to take part in a five-year test of the safety of a new treatment involving neural stem cells.

The researchers are looking for people who suffered an injury to the middle or lower levels of the spine's thoracic vertebrae between one and two years ago. According to UCSD, the injury must be between the seventh and 12th thoracic vertebrae.

"The goal of this study is to evaluate the safety of transplanting neural stem cells into the spine for what one day could be a treatment for spinal cord injuries," said Dr. Joseph Ciacci, the study's principal investigator and a neurosurgeon at UC San Diego Health System. "The study's immediate goal, however, is to determine whether injecting these neural stem cells into the spine of patients with spinal cord injury is safe."

The doctors also want to know how long the transplanted stem cells will last, and whether drugs designed to prevent rejection by the immune system are effective, according to UCSD Health.

The researchers will also look for possible changes in motor and sensory function, bowel and bladder function, and pain levels.

The stem cells were tested in laboratory rats by Ciacci and Dr. Martin Marsala, of the UC San Diego School of Medicine. They detected signs of improved motor function with minimal side effects. The cells have also been tested for safety in human patients with amyotrophic lateral sclerosis - commonly known as ALS or Lou Gehrig's Disease.

UCSD cautioned prospective test subjects that since human tests are just beginning, unforeseen risks, complications or unpredictable outcomes are possible.

The clinical trial at UC San Diego Health System is funded by Neuralstem Inc. and was launched and supported by the UC San Diego Sanford Stem Cell Clinical Center. The center was recently created to "advance leading-edge stem cell medicine and science, protect and counsel patients, and accelerate innovative stem cell research into patient diagnostics and therapy," according to UCSD.

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UCSD test calls for spinal cord injury patients

SAN DIEGO The UC San Diego Health System put out a call Monday for eight spinal cord injury patients to take part in a five-year test of the safety of a new treatment involving neural stem cells.

The researchers are looking for people who suffered an injury to the middle or lower levels of the spines thoracic vertebrae between one and two years ago. According to UCSD, the injury must be between the seventh and 12th thoracic vertebrae.

The goal of this study is to evaluate the safety of transplanting neural stem cells into the spine for what one day could be a treatment for spinal cord injuries, said Dr. Joseph Ciacci, the studys principal investigator and a neurosurgeon at UC San Diego Health System. The studys immediate goal, however, is to determine whetherinjecting these neural stem cells into the spine of patients with spinal cord injury is safe.

The doctors also want to know how long the transplanted stem cells will last, and whether drugs designed to prevent rejection by the immune system are effective, according to UCSD Health.

The researchers will also look for possible changes in motor and sensory function, bowel and bladder function, and pain levels.

The stem cells were tested in laboratory rats by Ciacci and Dr. Martin Marsala, of the UC San Diego School of Medicine. They detected signs of improved motor function with minimal side effects. The cells have also been tested for safety in human patients with amyotrophic lateral sclerosis commonly known as ALS or Lou Gehrigs Disease.

UCSD cautioned prospective test subjects that since human tests are just beginning, unforeseen risks, complications or unpredictable outcomes are possible.

The clinical trial at UC San Diego Health System is funded by Neuralstem Inc. and was launched and supported by the UC San Diego Sanford Stem Cell Clinical Center. The center was recently created to advance leading-edge stem cell medicine and science, protect and counsel patients, and accelerate innovative stem cell research into patient diagnostics and therapy, according to UCSD.

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Spinal injury patients needed for stem cell treatment study

U.S. scientists have regrown spinal cord neurons from a patients own cells They implanted the cells in injured rats aiming to reverse paralysis Found neurons caused animals' nervous system to rewire the spinal cord Connections extended into rats' limbs but they couldn't walk again Experiment offers hope to paralysed people as scientists get closer to cure But expert warns it could be months or years before human trials

By Sarah Griffiths

Published: 05:26 EST, 8 August 2014 | Updated: 07:56 EST, 8 August 2014

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Spinal injury victims left paralysed have been offered new hope of walking again thanks to a breakthrough in stem cell science.

U.S. scientists have regrown spinal cord neurons from a patients own cells for the first time.

Implanting the cells in rats, they found that the neurons caused the animals nervous systems to rewire the spinal cord and brain.

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Scientists grow links between spinal cord and brain for first time

Building upon previous research, scientists at the University of California, San Diego School of Medicine and Veteran's Affairs San Diego Healthcare System report that neurons derived from human induced pluripotent stem cells (iPSC) and grafted into rats after a spinal cord injury produced cells with tens of thousands of axons extending virtually the entire length of the animals' central nervous system.

Writing in the August 7 early online edition of Neuron, lead scientist Paul Lu, PhD, of the UC San Diego Department of Neurosciences and colleagues said the human iPSC-derived axons extended through the white matter of the injury sites, frequently penetrating adjacent gray matter to form synapses with rat neurons. Similarly, rat motor axons pierced the human iPSC grafts to form their own synapses.

The iPSCs used were developed from a healthy 86-year-old human male.

"These findings indicate that intrinsic neuronal mechanisms readily overcome the barriers created by a spinal cord injury to extend many axons over very long distances, and that these capabilities persist even in neurons reprogrammed from very aged human cells," said senior author Mark Tuszynski, MD, PhD, professor of Neurosciences and director of the UC San Diego Center for Neural Repair.

For several years, Tuszynski and colleagues have been steadily chipping away at the notion that a spinal cord injury necessarily results in permanent dysfunction and paralysis. Earlier work has shown that grafted stem cells reprogrammed to become neurons can, in fact, form new, functional circuits across an injury site, with the treated animals experiencing some restored ability to move affected limbs. The new findings underscore the potential of iPSC-based therapy and suggest a host of new studies and questions to be asked, such as whether axons can be guided and how will they develop, function and mature over longer periods of time.

While neural stem cell therapies are already advancing to clinical trials, this research raises cautionary notes about moving to human therapy too quickly, said Tuszynski.

"The enormous outgrowth of axons to many regions of the spinal cord and even deeply into the brain raises questions of possible harmful side effects if axons are mistargeted. We also need to learn if the new connections formed by axons are stable over time, and if implanted human neural stem cells are maturing on a human time frame -- months to years -- or more rapidly. If maturity is reached on a human time frame, it could take months to years to observe functional benefits or problems in human clinical trials."

In the latest work, Lu, Tuszynski and colleagues converted skin cells from a healthy 86-year-old man into iPSCs, which possess the ability to become almost any kind of cell. The iPSCs were then reprogrammed to become neurons in collaboration with the laboratory of Larry Goldstein, PhD, director of the UC San Diego Sanford Stem Cell Clinical Center. The new human neurons were subsequently embedded in a matrix containing growth factors and grafted into two-week-old spinal cord injuries in rats.

Three months later, researchers examined the post-transplantation injury sites. They found biomarkers indicating the presence of mature neurons and extensive axonal growth across long distances in the rats' spinal cords, even extending into the brain. The axons traversed wound tissues to penetrate and connect with existing rat neurons. Similarly, rat neurons extended axons into the grafted material and cells. The transplants produced no detectable tumors.

While numerous connections were formed between the implanted human cells and rat cells, functional recovery was not found. However, Lu noted that tests assessed the rats' skilled use of the hand. Simpler assays of leg movement could still show benefit. Also, several iPSC grafts contained scars that may have blocked beneficial effects of new connections. Continuing research seeks to optimize transplantation methods to eliminate scar formation.

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Dramatic growth of grafted stem cells in rat spinal cord

PUBLIC RELEASE DATE:

7-Aug-2014

Contact: Jackie Carr jcarr@ucsd.edu 619-543-6163 University of California - San Diego

Building upon previous research, scientists at the University of California, San Diego School of Medicine and Veteran's Affairs San Diego Healthcare System report that neurons derived from human induced pluripotent stem cells (iPSC) and grafted into rats after a spinal cord injury produced cells with tens of thousands of axons extending virtually the entire length of the animals' central nervous system.

Writing in the August 7 early online edition of Neuron, lead scientist Paul Lu, PhD, of the UC San Diego Department of Neurosciences and colleagues said the human iPSC-derived axons extended through the white matter of the injury sites, frequently penetrating adjacent gray matter to form synapses with rat neurons. Similarly, rat motor axons pierced the human iPSC grafts to form their own synapses.

The iPSCs used were developed from a healthy 86-year-old human male.

"These findings indicate that intrinsic neuronal mechanisms readily overcome the barriers created by a spinal cord injury to extend many axons over very long distances, and that these capabilities persist even in neurons reprogrammed from very aged human cells," said senior author Mark Tuszynski, MD, PhD, professor of Neurosciences and director of the UC San Diego Center for Neural Repair.

For several years, Tuszynski and colleagues have been steadily chipping away at the notion that a spinal cord injury necessarily results in permanent dysfunction and paralysis. Earlier work has shown that grafted stem cells reprogrammed to become neurons can, in fact, form new, functional circuits across an injury site, with the treated animals experiencing some restored ability to move affected limbs. The new findings underscore the potential of iPSC-based therapy and suggest a host of new studies and questions to be asked, such as whether axons can be guided and how will they develop, function and mature over longer periods of time.

While neural stem cell therapies are already advancing to clinical trials, this research raises cautionary notes about moving to human therapy too quickly, said Tuszynski.

"The enormous outgrowth of axons to many regions of the spinal cord and even deeply into the brain raises questions of possible harmful side effects if axons are mistargeted. We also need to learn if the new connections formed by axons are stable over time, and if implanted human neural stem cells are maturing on a human time frame months to years or more rapidly. If maturity is reached on a human time frame, it could take months to years to observe functional benefits or problems in human clinical trials."

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Dramatic growth of grafted stem cells in rat spinal cord injuries

PUBLIC RELEASE DATE:

5-Aug-2014

Contact: Meng Zhao eic@nrren.org 86-138-049-98773 Neural Regeneration Research

Cellular transplantation for repair of spinal cord injury is a promising therapeutic strategy that includes the use of a variety of neural and non-neural cells isolated or derived from embryonic and adult tissue as well as embryonic stem cells and induced pluripotent stem cells. In particular, transplants of neural progenitor cells (NPCs) have been shown to limit secondary injury and scar formation and create a permissive environment in the injured spinal cord through the provision of neurotrophic molecules and growth supporting matrices that promote growth of injured host axons. Importantly, transplants of NPC are unique in their potential to replace lost neural cells including neurons, astrocytes, and oligodendrocytes critical for reconstruction of the normal microenvironment of the spinal cord and restoration of connectivity and function. The model that Prof. Itzhak Fischer comes from Drexel University in USA has proposed focuses on the formation of a functional relay to reconnect the injured spinal cord and requires the formation of two synaptic connections, one between host axons and graft-derived neurons, and the other between graft axons and target sites within the host (Figure 1). The design of such a relay requires specific steps that assure: 1) graft survival and generation of neurons, 2) axon growth into and out of the graft by host axons and graft-derived neurons, respectively and 3) formation of physiologically active synaptic connections and restoration of function. The relevant study has been published in the Neural Regeneration Research (Vol. 9, No. 12, 2014).

###

Article: " Transplanting neural progenitors to build a neuronal relay across the injured spinal cord." by Christopher Haas, Itzhak Fischer (Drexel University College of Medicine, Department of Neurobiology & Anatomy, Philadelphia, PA, USA)

Haas C, Fischer I. Transplanting neural progenitors to build a neuronal relay across the injured spinal cord. Neural Regen Res. 2014;9(12): 1173-1176.

Contact: Meng Zhao eic@nrren.org 86-138-049-98773 Neural Regeneration Research http://www.nrronline.org/

AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.

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Transplanting neural progenitors to build a neuronal relay across the injured spinal cord

The decision to donate her baby's cord blood was "a no-brainer," said Michael's mother, Megan Kuttler of West Conshohocken. "If it could help somebody else, of course I wanted to."

Most expectant parents in the Philadelphia region do not have that opportunity.

"Women want to donate, but we can't afford to collect it," said Dennis Todd, CEO at Community Blood Services in Montvale, N.J. The agency - one of only 21 public cord-blood banks in the nation that provide units for transplants - receives an average of five calls or e-mails a week from expectant parents asking how they can contribute their baby's cord blood for the greater good.

The answer is almost always, "Sorry, but you can't."

"It's tough to do a good deed," said Frances Verter, director of the nonprofit Parent's Guide to Cord Blood Foundation.

Unless a woman delivers at one of the relatively few hospitals affiliated with a public cord-blood bank, her options are limited.

The Carolinas Cord Blood Bank, part of Duke University, is one of the few public banks that will send collection kits to qualified donors.

Only the most motivated women donate this way.

To do it, the mother has to fill out forms, request a kit, and ask the person who delivers her baby to take an online certification course and collect six vials of maternal blood as well as the baby's cord blood. Then the mother has to ship the package within 48 hours to the lab.

What is surprising is that so many are willing to do it. Duke can't fill all the requests it receives.

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Umbilical-cord stem cells valuable, but usually wasted

Working Paper

4-2014

Stem cell-based therapies are an emerging branch of medicine with the purpose of restoring tissue function for patients with serious injuries, such as a spinal cord injury. As a result, scientists and engineers are increasing research efforts in the field of regenerative medicine. Due to the delicate nature of stem cells, producing the large quantity required for a successful therapy has proved challenging. In recent years, research has shown the potential of stem cell-based therapies, and thus there is a need for the commercialization of these treatments. The proposed facility targets the demand for spinal cord injury treatments and can support production for both clinical trials and a commercial release. Bioreactors designed specifically for the culture and growth of stem cells have flexibility in their ability to support different stem cell lines for various therapies. Small reactors in parallel can easily adapt to changes in production size. This process also takes advantage of the best options currently available for purification and preservation to maximize the product yield.

Due to the strict regulations set in place by the FDA and lack of adequate funding, there is an untapped market for stem cell therapies for spinal cord injuries. Approximately 250,000 people in the United States suffer from spinal cord injuries, varying in severity, and this patient base increases at a rate of 12,000 new injuries every year (Spinal Cord Injury Facts and Figures, 2009). Future markets include expansion into Europe and Asia.

There are two steps to this proposal: the upstream process and the downstream process. The upstream process includes the scale-up, differentiation, and purification of human embryonic stem cells; the downstream process consists of the scale-up of neurons for injection. The upstream process will be built initially and yield enough cells for clinical trials, without incurring the capital costs of building the entire plant. Upon success of the clinical trials, the downstream process will be built for maximum production. The profitability of this proposal is based on running 26 batches a year at 1.02x1010 cells per batch or 2.66x1011 cells per year. By targeting 5,000 patients, two percent of the current market, and charging $45,000 per dose, a profitable profile can be created. Assuming 50% production capacity the first year and a ten-year plant life, the ROI, NPV, and IRR of the proposal are 226.09%, $961,892,600, and 242.81% respectively. Using a 50% production capacity allows for higher profit margins upon expansion. The proposed plan will meet the need of this growing market.

Date Posted: 25 July 2014

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"Stem Cell Therapy for Spinal Cord Injuries" by Priya ...

Tissue engineering and vascular biology expert Guohao Dai, assistant professor in the Department of Biomedical Engineering at Rensselaer Polytechnic Institute, recently won a Faculty Early Career Development Award (CAREER) from the National Science Foundation (NSF).

Dai will use the five-year, $440,000 grant to advance his research into bio-fabricating human tissues with 3-D cell printing technology. Adult neural stem cells are known to hold a great potential for treating disease and damage to the nervous system. However, these cells are both rare and difficult to use in a laboratory setting. The cells lose their potency quickly upon being removed from their native environment, making it difficult to study them.

With his CAREER Award, Dai seeks to design and develop a new way of using 3-D cell printing technology to create a "vascular niche" that replicates the native environment of adult neural stem cells. With the ability to prolong the potency of the cells and precisely control the parameters and components of its vascular niche, researchers would be better positioned to study the cells and their role in treating treat spinal cord injury and neurodegenerative diseases.

"Adult neural stem cells hold so much promise for treating injury and disease, but they are extremely difficult to work with," Dai said. "We believe that we can apply 3-D tissue printing technology to create a vascular niche that will prolong the life of the cells and, in turn, enable new opportunities for studying how they may be used to treat injury and fight disease."

The CAREER Award is given to faculty members at the beginning of their academic careers and is one of NSF's most competitive awards, placing emphasis on high-quality research and novel education initiatives. Dai will collaborate on his CAREER project with two stem cells experts, Rensselaer Associate Professor of Biomedical Engineering Deanna Thompson and Neural Stem Cell Initiative Scientific Director Sally Temple.

Most laboratory cell cultures are 2-D. This is significantly different from the human body, where most cells are in a 3-D environment. A major challenge in creating and studying 3-D tissues is the diffusion limit in the tissues, which quickly lose potency or die without a flow of blood to provide oxygen and nutrients.

To help overcome this challenge, Dai and his collaborators have spent years developing a 3-D tissue printer -- both the hardware and the software. The unique device prints biological tissue by carefully depositing cells, hydrogels, and other materials one layer at a time. Using this platform, Dai developed the technology to create perfused vascular channels, which provide nutrients and oxygen to the printed tissues.

"Blood vessels run throughout almost every part of our bodies, bringing the oxygen and nutrients that allow our cells to survive. The same is true of 3-D cell cultures. They need a vascular system in order to survive," Dai said. "Our device can print 3-D tissues with small channels that function as blood vessels. This enables us to print cells with extracellular matrices that closely replicate those found within the body."

Dai's research team used the 3-D tissue printing technology to help study how the functions of the vascular endothelium -- a thin layer of cells that line entire circulatory system -- are affected by environmental factors such as interactions with blood and smooth muscle cells. A dysfunctional endothelium is known to be a contributor to many vascular diseases including inflammation, thrombosis, and atherosclerosis.

With his CAREER Award, Dai is applying his expertise and unique 3-D tissue printing technology to replicate the native environment of adult neural stem cells. If successful, the project could significantly expand the potency and life span of the cells in laboratory settings, and lead to a better understanding of how this extracellular environment influences the behavior of the cells.

See the original post here:
3-D-printed tissues advance stem cell research

Renowned Israeli stem-cell researcher in Fairfield Aug. 6

By Cindy Mindell

Dr. Yaqub Hanna

A leading Israeli scientist who has pioneered groundbreaking stem-cell reprogamming research will discuss his work on Wednesday, Aug. 6 at Jewish Senior Services in Fairfield.

Together with a team of researchers at the Weizmann Institute of Science Department of Molecular Genetics in Rehovot, Israel, Dr. Jacob (Yaqub) Hanna has overcome a major roadblock in the use of human stem cells for medical purposes. Funded by a grant from the Israel Cancer Research Fund, their pioneering breakthrough was recently published in the peer-reviewed international science journal, Nature.

Its not only Hannas work that is note-worthy: the award-winning research scientist is a Palestinian living in Israel, a native of Kafr Rama in the Galilee and the son of two medical doctors.

Hanna earned a BS in medical sciences summa cum laude in 2001, an MS in microbiology and immunology in 2003, and a PhD-MD in immunology summa cum laude in 2007, all from the Hebrew University of Jerusalem, where he was among the top five percent of all Israeli medical-school graduates. After completing his PhD, Hanna decided to abandon clinical medicine and focus on research, and spent four years conducting postdoctoral research in the lab, part of the Whitehead Institute for Biomedical Research at MIT.

During his postdoctoral work, Hanna was the first non-American to receive a prestigious Novartis Fellowship from the Helen Hay Whitney Foundation. He joined the Weizmann Institute Department of Molecular Genetics upon his return to Israel in 2011. That year, he received the Clore Prize for distinguished new faculty at the Weizmann Institute and was accepted as a Yigal Alon Program Scholar for junior faculty in Israel. He is also the recipient of the Wolf Foundations Krill Prize for Excellence in Scientific Research and the 2013 Rappaport Prize in Biomedical Research.

Hanna has had to find a way to navigate between his personal and professional identities.

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