NIH stem-cell programme closes

Bradley J. Fikes

Stem-cell biologist Mahendra Rao expected five projects to receive support to set up clinical trials.

Stem-cell researchers at the US National Institutes of Health (NIH) have been left frustrated and confused following the demise of the agencys Center for Regenerative Medicine (CRM). The intramural programmes director, stem-cell biologist Mahendra Rao, left the NIH, in Bethesda, Maryland, on 28March, and the centres website was taken down on 4 April. Although no official announcement had been made at the time Nature went to press, NIH officials say that they are rethinking how they will conduct in-house stem-cell research.

Researchers affiliated with the centre say that they have been left in the dark. When contacted by Nature on 7April, George Daley, a stem-cell biologist at Harvard Medical School in Boston, Massachusetts, and a member of the centres external advisory board, said that he had not yet been told of Raos departure or the centres closure.

The CRM was established in 2010 to centralize the NIHs stem-cell programme. Its goal was to develop useful therapies from induced pluripotent stem (iPS) cells adult cells that have been converted into embryonic-like stem cells and shepherd them towards clinical trials and regulatory approval. Its budget was intended to be $52million over seven years.

Rao took the helm in 2011. Relations seem to have soured last month owing to an NIH decision to award funding to only one project aiming to move iPS cells into a clinical trial. Rao says he resigned after this became clear. He says that he had hoped that five trials would be funded, especially because the centre had already sorted out complex issues relating to tissue sources, patents and informed consent.

James Anderson, director of the NIHs Division of Program Coordination, Planning, and Strategic Initiatives, which administered the CRM, counters that only one application that made by Kapil Bharti of the National Eye Institute in Bethesda and his colleagues received a high enough score from an external review board to justify continued funding. The team aims to use iPS cells to treat age-related macular degeneration of the retina, and hopes to commence human trials within a few years. Several other proposals, which involved the treatment of cardiac disease, cancer and Parkinsons disease, will not receive funding to ready them for clinical trials. Anderson stresses that Bhartis trial will not be affected by the CRMs closure.

NIH

Therapies based on induced pluripotent stem cells, here differentiating into retinal cells on a scaffold, were the focus of the Center for Regenerative Medicine.

Other human iPS-cell trials are further along. For example, one on macular degeneration designed by Masayo Takahashi at the RIKEN Center for Developmental Biology in Kobe, Japan, began recruiting patients last August.

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NIH stem-cell programme closes

Stem Cells Show Promise for Stroke Recovery

Brenda Goodman HealthDay Reporter Posted: Monday, April 7, 2014, 4:00 PM

MONDAY, April 7, 2014 (HealthDay News) -- In an early test, researchers report they've safely injected stem cells into the brains of 18 patients who had suffered strokes. And two of the patients showed significant improvement.

All the patients saw some improvement in weakness or paralysis within six months of their procedures. Although three people developed complications related to the surgery, they all recovered. There were no adverse reactions to the transplanted stem cells themselves, the study authors said.

What's more, the researchers said, two patients experienced dramatic recoveries almost immediately after the treatments.

Those patients, who were both women, started to regain the ability to talk and walk the morning after their operations. In both cases, they were more than two years past their strokes, a point where doctors wouldn't have expected further recovery.

The results have encouraged researchers to plan larger and longer tests of the procedure, which uses stem cells cultured from donated bone marrow.

An expert who was not involved in the research called it a promising first step.

"It's a small, early human study. It takes multiple steps to get to something clinically useful, and this is a nice, early step," said Dr. Steven Cramer, clinical director of the Stem Cell Research Center at the University of California, Irvine.

The findings were to be presented Monday at the American Association of Neurological Surgeons annual meeting, in San Francisco. The results of studies presented at meetings are considered preliminary until they've been published in peer-reviewed medical journals.

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Stem Cells Show Promise for Stroke Recovery

VIDEO | Ateneo graduate dies after undergoing stem cell therapy

By: Ina Zara, News5 April 7, 2014 9:05 PM

Contributed file photo of Katherine Grace Tan.

InterAksyon.com The online news portal of TV5

MANILA, Philippines A cum laude graduate from the Ateneo de Manila University, who was suffering from Hodgkin's lymphoma, died last year after undergoing embryonic stem cell therapy that was allegedly administered by Antonia Park, the alternative medicine doctor of former President Gloria Macapagal-Arroyo.

Bernard Tan claimed that Park had promised that within three months, his 23-year-old daughter, Katherine Grace Tan, would be cured of her disease, which according to the doctor was not cancer but just hormonal imbalance.

But after undergoing treatment and strictly following a juice diet, Katherine got weaker and died.

Earlier this month, it was reported that Park, of the Green & Young Health & Wellness Center,admitted that she wasnt licensed to practice in the Philippines.

Records from the theProfessional Regulatory Commission as of August 2013 showed that Park was not on the list of physicians authorized to practice medicine in the country.

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VIDEO | Ateneo graduate dies after undergoing stem cell therapy

Stem Cell Research – Pros and Cons – explorable

The debate of the pros and cons of stem cell research clearly illustrate the difficult ethics evaluations researchers sometimes must do.

All scientists must consider whether the positive effects from their research are likely to be significantly higher than the negative effects.

Stem Cells are crucial to develop organisms. They are nonspecialized cells which have the potential to create other types of specific cells, such as blood-, brain-, tissue- or muscle-cells.

Stem cells are in all of our body and lives, but are far more potent in a fetus (also spelled foetus, ftus, faetus, or ftus) than in an adult body.

Some types of stem cells may be able to create all other cells in the body. Others have the potential to repair or replace damaged tissue or cells.

Embryonic Stem Cells are developed from a female egg after it is fertilized by sperm. The process takes 4-5 days.

Stem cell research is used for investigation of basic cells which develop organisms. The cells are grown in laboratories where tests are carried out to investigate fundamental properties of the cells.

There are stem cells in the both placenta and blood contained in the placenta. Also the primary source of stem cells is from blastocysts. These are fertilized human eggs that were not implanted into a woman.

The controversy surrounding stem cell research led to an intense debate about ethics. Up until the recent years, the research method mainly focused on Embryonic Stem Cells, which involves taking tissue from an aborted embryo to get proper material to study. This is typically done just days after conception or between the 5th and 9th week.

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Stem Cell Research - Pros and Cons - explorable

Royal Engineer's bungee jump to boost Enzo stem cell appeal

Royal Engineer's bungee jump to boost Enzo stem cell appeal

12:50pm Sunday 6th April 2014 in News

A SOLDIER has undertaken a bungee jump off Middlesbroughs Transporter Bridge to raise funds for stem cell treatment for a toddler who was diagnosed with cerebral palsy after being starved of oxygen during labour.

Ripon-based Royal Engineer Stephen Maher said he wanted to boost the 60,000 appeal to enable 18-month-old Enzo Thompson to develop basic physical skills.

The 27-year-old said he hoped the 160ft leap would also raise awareness of the fundraising campaign for the toddler from Hampshire.

Enzos mother, Caroline, said the damage caused to Enzo's brain meant he is unable to process the signals that his brain is sending to his body.

She said: Stem cell treatment is a way of repairing and replacing these damaged cells.

In the long run we hope that the treatment will offer our son a better quality of life and the chance to be free and independent.

To donate, visit Justgiving.com/Enzostemcell or text ENZO55 followed by your donation to 70070.

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Royal Engineer's bungee jump to boost Enzo stem cell appeal

Radio Personality: Remarkable Response to Stem Cell Treatment

Posted on: 7:45 pm, April 5, 2014, by Darcie Loreno, updated on: 07:53pm, April 5, 2014

CLEVELAND, Ohio Two months after undergoing an experimental new stem cell procedure, a popular Cleveland on-air personality is speaking out about her progress.

WZAKs Kym Sellers, who has multiple sclerosis, became in February the first person in Ohio to have the procedure, which extracts millions of stem cells from body fat, then deploys them back into the body through an IV.

The outpatient procedure was performed at the Ohio Stem Cell Treatment Center in Beachwood by a team of surgeons including the centers founders Dr. Mark Foglietti and Dr. Michael Kellis.

Kym still comes to tears thinking about it. The procedure isnt FDA approved and is considered patient-funded research.

Since the procedure, Kym said shes noticed improvements in her breathing, pain levels, edema and mobility. She said she can tell her body is trying to fight the disease.

Her doctors call it a remarkable response and are already planning to treat her again.

For much more on Kym and her procedure, click here.

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Radio Personality: Remarkable Response to Stem Cell Treatment

Stem cell research in Alabama gets anonymous $1 million boost

BIRMINGHAM, Alabama -- A new organization looking to stimulate stem cell research got a shot in the arm last month with an anonymous $1 million donation.

The Alabama Institute of Medicine wants to use the money to help fund four to five pilot studies which typically cost about $100,000 to $300,000 a piece, said Tory Williams co-founder of the private, nonprofit organization.

On Monday AIM will ask Alabama scientists to begin submitting their applications for funding, a process called a Request For Application (RFA). The applications will be reviewed on a double-blind basis -- meaning the grantee not knowing the reviewer and vice versa.

"We want to raise money for pilot studies aimed at treating such diseases as cancer, diabetes, cardiac, sports injury and neurological diseases such as Alzheimer's and Parkinson's," she said.

She said she feels good about raising their goal of $10 million this year. A longer term goal is to develop a hospital where regenerative medical treatments can be administered.

She said 90 percent of the funds will go toward research. All donations are placed in AIMs scientific trust fund and are recognized as tax- deductible donations.

In 2012 she worked to help pass a law for spinal cord injury research at the University of Alabama at Birmingham. During that time she saw how scientists were not being encouraged to engage in advanced stem cell research like hESCs -- human embryonic stem cells.

She acknowledged that Alabama has a segment of the population that is opposed to such research on religious grounds but she said she has been amazed by the support.

"Research involving embryos has been controversial," she said. "But over 500,000 embryos are thrown away every year from fertility clinics. It almost like recycling. Take something that is being thrown away every year and treat people dying of these diseases."

Williams was recently featured in a Q&A in the Knoepfer Lab Blog at the University of California-Davis School of Medicine.

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Stem cell research in Alabama gets anonymous $1 million boost

Scientists smash barrier to growing organs from stem cells

8 hours ago by Josh Barney U.Va. scientists Bernard and Chris Thisse have created a zebrafish embryo by instructing stem cells.

(Phys.org) Scientists at the University of Virginia School of Medicine have overcome one of the greatest challenges in biology and taken a major step toward being able to grow whole organs and tissues from stem cells. By manipulating the appropriate signaling, the U.Va. researchers have turned embryonic stem cells into a fish embryo, essentially controlling embryonic development.

The research will have dramatic impact on the future use of stem cells to better the human condition, providing a framework for future studies in the field of regenerative medicine aimed at constructing tissues and organs from populations of cultured pluripotent cells.

In accomplishing this, U.Va. scientists Bernard and Chris Thisse have overcome the most massive of biological barriers. "We have generated an animal by just instructing embryonic cells the right way," said Chris Thisse of the School of Medicine's Department of Cell Biology.

The importance of that is profound. "If we know how to instruct embryonic cells," she said, "we can pretty much do what we want." For example, scientists will be able one day to instruct stem cells to grow into organs needed for transplant.

Directing Embryonic Development

The researchers were able to identify the signals sufficient for starting the cascade of molecular and cellular processes that lead to a fully developed fish embryo. With this study came an answer to the longstanding question of how few signals can initiate the processes of development: amazingly, only two.

The study has shed light on the important roles these two signals play for the formation of organs and full development of a zebrafish embryo. Moreover, the Thisses are now able to direct embryonic development and formation of tissues and organs by controlling signal locations and concentrations.

The embryo they generated was smaller than a normal embryo, because they instructed a small pool of embryonic stem cells, but "otherwise he has everything" in terms of appropriate development, said Bernard Thisse of the Department of Cell Biology.

Their next steps will be to attempt to reproduce their findings using mice. They expect molecular and cellular mechanisms will be extremely similar in mice and other mammals including humans.

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Scientists smash barrier to growing organs from stem cells

FDA Approves CardioCell's Phase 2A Trial For CHF Stem Cell Therapy

By Estel Grace Masangkay

CardioCell LLC announced that it has received FDA approval for its investigational new drug (IND) application for a U.S.-based Phase IIA clinical study evaluating its allogeneic stem-cell therapy for patients with chronic heart failure (CHF).

Dr. Sergey Sikora, CardioCells president and CEO, said, With the FDAs IND approval, CardioCell is pleased to proceed with a Phase 2a CHF clinical trial based on the safety data reported in previous clinical trials using our unique, hypoxically grown stem cells. At the studys conclusion we will understand if our therapy produces signs of improvement in a population of patients with dilated CHF, a condition largely unaddressed by current therapies. Dilated CHF is characterized by a viable but non-functioning myocardium in which cardiomyocytes are alive but are not contracting as they should. We hope that unique properties of our itMSCs will transition patients cardiomyocytes from viable to functioning, eventually improving or restoring heart function.

The company has developed an ischemic tolerant mesenchymal stem cells (itMSC) treatment for the type of dilated CHF that is not related to coronary artery disease. The treatment could potentially apply to about 35 percent of CHF patients. Only CardioCells CHF therapies feature itMSCs, exclusively licensed from CardioCells parent company Stemedica Cell Technologies Inc. The company said Stemedicas bone marrow-derived, allogeneic MSCs are different from other MSCs because they are grown under hypoxic conditions that closely resemble the environment in which they thrive on in the body.

Dr. Stephen Epstein, CardioCells Scientific Advisory Board Chair, said Although past trials have tested the efficacy of different stem cells in patients with DCM, CardioCells itMSCs, grown under chronic hypoxic conditions, are unique. As compared to stem cells grown under normoxic conditions, they express higher levels of factors that could exert beneficial effects on the mechanisms contributing to myocardial dysfunction and disease progression. This study, therefore, provides an exciting opportunity to test the potential of these itMSCs to attenuate or eliminate these mechanisms and, in so doing, improve patient outcomes.

The trial entitled A Phase 2a, Single-Blind, Placebo-Controlled, Crossover, Multi-Center, Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-Tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-Ischemic Etiology, will be conducted at Emory University, Northwestern University, and the University of Pennsylvania in May this year.

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FDA Approves CardioCell's Phase 2A Trial For CHF Stem Cell Therapy

Umbilical Cord Stem Cell Therapy Clinical Trial for Multiple Sclerosis Gets Green Light

Dallas, TX (PRWEB) April 03, 2014

Translational Biosciences, a subsidiary of Medistem Panama, has received the green light for a phase I/II clinical trial using human umbilical cord-derived mesenchymal stem cells (UC-MSC) for multiple sclerosis from the Comit Nacional de Biotica de la Investigacin (CNEI) Institutional Review Board (IRB) in Panama.

According to the US National Multiple Sclerosis Society, in Multiple Sclerosis (MS), an abnormal immune-mediated T cell response attacks the myelin coating around nerve fibers in the central nervous system, as well as the nerve fibers themselves. This causes nerve impulses to slow or even halt, thus producing symptoms of MS that include fatigue; bladder and bowel problems; vision problems; and difficulty walking. The Cleveland Clinic reports that MS affects more than 350,000 people in the United States and 2.5 million worldwide.

Mesenchymal stem cells harvested from donated human umbilical cords after normal, healthy births possess anti-inflammatory and immune modulatory properties that may relieve MS symptoms. Because these cells are immune privileged, the recipients immune system does not reject them. These properties make UC-MSC interesting candidates for the treatment of multiple sclerosis and other autoimmune disorders.

Each patient will receive seven intravenous injections of UC-MSC over the course of 10 days. They will be assessed at 3 months and 12 months primarily for safety and secondarily for indications of efficacy.

The stem cell technology being utilized in this trial was developed by Neil Riordan, PhD, founder of Medistem Panama. The stem cells will be harvested and processed at Medistem Panamas 8000 sq. ft. ISO-9001 certified laboratory in the prestigious City of Knowledge. They will be administered at the Stem Cell Institute in Panama City, Panama.

From his research laboratory in Dallas, Texas, Dr. Riordan commented, Umbilical cord tissue provides an abundant, non-controversial supply of immune modulating mesenchymal stem cells. Preclinical and clinical research has demonstrated the anti-inflammatory and immune modulating effects of these cells. We look forward to the safety and efficacy data that will be generated by this clinical trial; the first in the western hemisphere testing the effects of umbilical cord mesenchymal stem cells on patients with multiple sclerosis.

The Principle Investigator is Jorge Paz-Rodriguez, MD. Dr. Paz-Rodriguez also serves as the Medical Director at the Stem Cell Institute.

For detailed information about this clinical trial visit http://www.clinicaltrials.gov . If you are a multiple sclerosis patient between the ages of 18 and 55, you may qualify for this trial. Please email trials (at) translationalbiosciences (dot) com for more information about how to apply.

About Translational Biosciences

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Umbilical Cord Stem Cell Therapy Clinical Trial for Multiple Sclerosis Gets Green Light