“Latest Stem Cells News”

Emory University researchers have received approval from the Food and Drug Administration (FDA) to advance to the next phase of a landmark trial to treat patients with Amyotrophic Lateral Sclerosis (ALS) using human neural stem cells.

The Phase I trial, currently underway exclusively at Emory University, is designed to assess the safety of implanting neural stem cells into the spinal cord in up to 18 people with ALS and began in January 2010. The first 12 patients received neural stem cell transplants in the lumbar, or lower, region of the spinal cord. After reviewing safety data from these patients, the FDA has granted approval for the trial to advance to the final two groups of patients (three in each group), all of who will be transplanted in the cervical, or upper, region of the spinal cord.

“This represents a major accomplishment for the trial, meaning that we have achieved our stated goal of proving safety in the first 12 patients who received lumbar spinal injections,” says Jonathan Glass, MD, Professor of Neurology, Emory School of Medicine and director of the Emory ALS Center.

“Our next objective is to demonstrate that we can deliver the cells safely to the cervical spinal cord, which is particularly important because therapy in this region may help patients better maintain their ability to breathe.”

Incoming search terms:

In a bold move that is sure to shake the foundations of the United States FDA, a group of American doctors have published a set of strict clinical guidelines that will allow US doctors to treat patients with their own Adult Stem Cells.

Your Own Stem Cells Are Not a Drug

This move by the American Stem Cell Therapy Association comes in response to the FDA’s position that a person’s own stem cells should be classified as a drug, thus subject to the exact same set of standards that a drug like Viagra or Lipitor or Vioxx would be examined under.

However, these US doctors are correct in believing that adult stem cell therapy with the patient’s own cells is governed under the practice of medicine, not under drug production guidelines.

From the stem cell press release:

Adult stem cells can be processed with the same techniques commonly used in existing in-vitro fertilization (IVF) labs. “Like the human cells and tissue used in IVF, adult stem cells are not drugs,” stated Christopher J. Centeno, M.D., a physician who worked on the guidelines and whose medical practice includes the use of the Regenexx procedure, which uses patients own stem cells to treat orthopedic conditions.

Slowing Progress, Costing Lives- the US FDA at Work

“Making the stem cells in your own body a drug won’t make them safer, will dramatically reduce availability of treatment, and will increase bureaucratic red tape.” stated Dr. Centeno.

Dr. Centeno is absolutely right.  These are your own cells and having the FDA regulate your own body won’t be helping anybody as there is no downside to having your own stem cells implanted.

Let me repeat that- there is no downside to having your own Adult Stem Cells implanted. Either they will help you or they won’t (no effect).  This has been proven in thousands of studies.

Your own stem cells should be an extra tool your doctor should be able to use to help you.  No, adult stem cells are not a cure yet, but they do help in the majority of cases.

Again, your own stem cells should be a tool in your responsible doctor’s tool kit that may or may not be able to help, but should be made available to you as there is no downside.  What does the patient have to lose?  A man in end stage heart failure about to die- give him his own stem cells, they should help. He may not be beating Husain Bolt in a 100 meter sprint, but should improve.  A spinal cord injury victim, give him his own stem cells, they should help.  He/she may not be walking, but it could be beneficial in some ways.  A diabetic, give him his own stem cells- they should improve his insulin levels. And if your own stem cells don’t help- there is no harm done- thousands of studies have proven this.

And what if your own Adult Stem Cells work only 5% of the time for a particular lethal disease and your doctor wants to try to save your life? Hey! It will save 5% more than zero. With no downside, why not? And if the FDA has its way, that 5% will be 0. It is up to all of us to make a stand. And these clinical guidelines are the first step.

If you are a patient of any kind and reading this, I urge you to go to Safe Stem Cells Now, a patient run organization demanding the use of their own stem cells.

Incoming search terms:

Italian Welfare Undersecretary Ferruccio Fazio disapproves of private biobanks and is clearly in favor of the “allogenic” conservation of umbilical cord stem cells, meaning the conservation of stem cells saved for the exclusive use of the donor-patient. Speaking about a government report on “the appropriate use of umbilical cord stem cells”, Fazio outlined the government’s approach on the issue. A few weeks after a ministerial decree dictating new regulations for umbilical cord conservation, Fazio explained autologous donation, meaning conservation of stem cells for yourself, “is not only less useful, but also less efficient as science has demonstrated”.

The only exception allowed by the ministerial decree is “the conservation of umbilical cord blood to be used by families with children who are at risk for diseases that are genetically determined, which are scientifically proven and clinically approved to be treated with umbilical cord stem cells upon presenting clinical documentation released by a specialist”. From a scientific standpoint, underlined Fazio, “the use of hematopoietic stem cells for allogenic transplants creates another advantage because these stem cells eliminate diseased cells that remain after chemotherapy or radiotherapy, thanks the ability of special white blood cells from the donor to recognize them as foreign and destroy the residual diseased cells, performing an actual ‘cellular therapy’. This effect of hematopoietic stem cells transplants is known as ‘Graft versus Leukemia’.

Incoming search terms:

Rutgers Establishes Stem Cell Repository for the Study of Mental Health Disorders

Rutgers University Cell and DNA Repository (RUCDR) has established a stem cell repository for the National Institute of Mental Health that will better enable researchers to study a variety of mental health disorders, including autism, attention deficit disorder, major depression, and schizophrenia, that affect millions of Americans.

“The biology of mental health disorders has been especially difficult to study because brain tissue from affected individuals is seldom available,” said principal investigator Jay A. Tischfield, Duncan and Nancy Macmillan Professor and director of the Human Genetics Institute. “With the award of this new grant, we will provide researchers with new biological tools that will greatly enhance our understanding of the biological basis of mental disorders.”

The NIMH Repository Supporting Stem Cell Research will be part of the existing NIMH Center for Collaborative Genetic Studies on Mental Disorders which has been based at Rutgers since 1998. The NIMH has awarded Rutgers $96 million since then to establish cell lines, DNA and RNA for the NIMH Genetics Initiative by collecting samples from families with a wide range of mental health disorders. The center’s goal – which is being expanded with a $1.2 million stem cell supplement – is to increase the repertoire of resources to researchers around the world.

Incoming search terms:

Much to the dismay of patients and physicians, cancer stem cells — tiny powerhouses that generate and maintain tumor growth in many types of cancers — are relatively resistant to the ionizing radiation often used as therapy for these conditions. Part of the reason, say researchers at Stanford University School of Medicine, is the presence of a protective pathway meant to shield normal stem cells from DNA damage. When the researchers blocked this pathway, the cells became more susceptible to radiation.

“Our ultimate goal is to come up with a therapy that knocks out the cancer stem cells,” said Robert Cho, MD, a clinical instructor of pediatrics. “If you irradiate a tumor and kill a lot of it but leave the cancer stem cells behind, the tumor has the ability to grow back.” As a result, patients can relapse months or years after seemingly successful treatment.

Cho and radiation oncologist and post-doctoral fellow Maximilian Diehn, MD, PhD, are co-first authors of the research, which was published on Feb. 4 in Nature. They collaborated with scientists at Stanford and City of Hope National Medical Center to conduct the research. They studied breast epithelial stem cells from humans and mice to unravel why cancer stem cells are more resistant to radiation than other cancer cells.

“Since cancer stem cells appear to be responsible for driving and maintaining tumor growth in many tumors, it is critical to understand the mechanisms by which these cells resist commonly used therapies such as chemotherapy and radiotherapy,” said Diehn. “Ultimately, we hope to improve patient outcomes by developing therapeutic approaches that directly target cancer stem cells or that overcome their resistance mechanisms.”

The origin of cancer stem cells is still under debate. Some may arise from normal adult stem cells gone awry. Others may represent specialized cells from adult tissues that have acquired a stem-cell-like state through a series of mutations. What’s clear is that cancer stem cells can reconstitute an entire tumor cell population when transplanted into an immune-deficient animal, and destroying them is likely to be critical in order to stop the growth and spread of the disease.

Incoming search terms:

A blood sample databank under the China Marrow Donor Program (CMDP), was officially established Monday at Zhongguancun of Beijing.
The new databank is now the largest for Chinese people in the world, according to Hong Junling, deputy head of CMDP management center.

The databank includes information such as the names and gender of nearly one million donors and information about to which ethnic groups the donors come from, Hong said.
It also covers such medical information as blood types, gene types and health status of the donors.

The CMDP, launched in 2001 by the Red Cross Society of China, aims to help millions of Chinese with blood diseases.
But Hong said the blood sample databank could help genetic analysis for major diseases other than blood diseases.

The blood sample databank has collected 970,000 samples and provided more than 1,200 patients with haematogenous stem cells, including 50-odd cases from abroad, according to Hong.
The number of samples is expected to reach one million by 2010.

Incoming search terms: