Neuralstem, Inc. (NYSE Amex: CUR) updated the progress of its ongoing Phase I human clinical trial of the company’s spinal cord stem cells in the treatment of ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig’s disease) at Emory University in Atlanta, Georgia. The company announced that, after reviewing the safety data from the first six non-ambulatory patients, the trial’s Safety Monitoring Board has unanimously approved moving to the next group of ALS patients, all of whom will be ambulatory.
“We are pleased with the progress of the trial to date, and look forward to moving directly into more recently-diagnosed patients,” commented Dr. Eva Feldman, PhD, MD, Principal Investigator of the trial and a consultant to Neuralstem. Dr. Feldman is Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System.
“We are encouraged by the Board’s approval to advance the trial to patients who have an earlier stage of the disease,” said Neuralstem’s CEO and president, Richard Garr. “While the primary endpoint of the trial is safety, we also hope to see some secondary endpoints showing efficacy. We are grateful to the patients, and their families, for participating in this trial.”
The first six patients treated in the trial were non-ambulatory. Of these, the first three received five injections each, unilaterally, in the lumbar region of the spinal cord. The next three received ten injections each, bilaterally in the lumbar region. All of the remaining patients in the trial will be ambulatory, and therefore represent earlier stages of disease progression. Of the ambulatory group, the first three patients will receive five injections each, unilaterally, in the lumbar region. The next three will receive ten injections each, bilaterally, in the lumbar region. After the required FDA approval, the final six patients in the trial will receive injections in the cervical region, representing both a progression of treatment up the spinal cord, as well as into more recently-diagnosed patients.
About The Trial
The Phase I trial to evaluate the safety of Neuralstem’s spinal cord stem cells in the treatment of ALS, the first FDA-approved ALS stem cell trial, has been underway since January, 2010. The trial will ultimately consist of up to 18 ALS patients, who will be examined at regular intervals post-surgery, with final review of the data to come six months after the last patient is treated. While the trial is primarily evaluating the safety of the cells and procedure, it will also seek some secondary efficacy endpoints including attenuation of motor function loss, maintenance of respiratory capacity, and stabilization of patients along the ALS functional rating scale.
The World Stem Cell Summit is the flagship international event uniting the stem cell community by bringing together scientists, patients, advocates, business people, investors, educators, ethicists, policy makers, government representatives, and others to network and learn from each other.
In 2010, the Summit will attract more than 1,200 attendees from 30 nations, 60 exhibitors and more than 200 endorsing organizations and media partners from around the world.
Poster abstract submission deadlines July 30th 2010.
The 2010 World Stem Cell Summit is the largest and most comprehensive multi-track stem cell conference, featuring more than 150 international speakers and 50 hours of in-depth science, business and society presentations. No other stem cell conference offers the breadth of content and global perspective. The agenda works to unite, educate, and harmonize the global stem cell community.
Cord Blood America, Inc. (http://www.cordblood-america.com) (OTC Bulletin Board: CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells, a biological insurance policy, to families nationwide and internationally, today said that clinical trials ongoing in the U.S. using umbilical cord blood in the treatment of cerebral palsy, high-risk hematologic cancer, injured spinal cords and Type 1 diabetes provide significant further evidence of the importance of storing umbilical cord blood at the time of birth.
“We are asked with some frequency why store these stem cells available only at birth. On our web site at www.corcell.com is a list of more than 70 diseases that are already treated by these stem cells, including acute and chronic leukemia’s, severe aplastic anemia, Hodgkin’s Disease, a number of inherited metabolic diseases and immune system disorders and malignancies including Ewing Sarcoma and Sickle Cell Disease,” said Matthew Schissler, co-founder and CEO. ”Once in a while, it is my duty and obligation to step away from the day-to-day and reflect on the larger scope of work in the umbilical cord blood stem cell arena. In doing so, I recognize that our loyal shareholders may not be privy to all of the data we receive, involving the outstanding studies with these cells. It is my hope that a simple statement such as this, can direct our shareholders to the resources publicly available.”
“What is truly exciting is that the National Institutes of Health at www.clinicaltrials.gov now lists clinical trials ongoing at such prestigious research institutions as Duke University and Memorial Sloan-Kettering Cancer Center to understand the possible usage of stem cell infusions for the treatment of intractable diseases, including Type I diabetes in children, cerebral palsy in children, chronic spinal cord injuries, lymphoma and other blood borne cancers,” Mr. Schissler said.
“Also, there is research ongoing elsewhere in the world to use umbilical cord blood stem cells to combat Alzheimer’s, cardiac disease, lupus, multiple sclerosis, muscular dystrophy, Parkinson’s Disease, rheumatoid arthritis and stroke. This truly is an excellent time to be involved in this sector as we work toward our goal of becoming the most significant stem cell company in the world,” said Mr. Schissler.
Cleveland, Ohio leveraged buyout firm Riverside Co. has acquired private cord blood bank Celvitae Biomedica S.A. in Madrid, Spain for undisclosed terms.
Celvitae is one of two cord blood banks licensed in Spain and authorized to work in the public health system, Riverside said in a release. It also has major commercial agreements with some of the leading insurance companies in the Spanish market.
Last year, Celvitae struck a strategic agreement with MD Anderson Internacional Espana, a cancer treatment center in Europe that ensures all cord blood stem cell samples collected in Spain are processed within 24 hours at its Madrid facilities.
). On * average, the noscript tag is called from less than 1% of internet * users. */–>Riverside will add Celvitae to its Crioestaminal platform, the Cantanhede, Portugal company that is a pioneer and market leader in the isolation and storage of cord blood stem cells. More than 40,000 parents have trusted the company to store their children’s stem cells.
Riverside acquired Crioestaminal last year. The Celvitae acquisition was made from Riverside Europe Fund IV. Riverside is co-headquartered in New York City.
The British Broadcasting Corporation, BBC, reports that scientists are working on research that will expand the use of skin cells beyond skin grafts for burn victims that may be the answer for curing a broad range of conditions, from cancer to spinal cord repair.
Sheila MacNeil, Professor of Tissue Engineering at the University of Sheffield in South Yorkshire, England states, “There is the potential to take a biopsy of skin from a patient with disease, culture the cells, alter them to make them grow into tissues you are interested in and also use them to study the basis of the genetic disease and then to design therapies that you can put back into the patient.”
Professor MacNeil added that the adult stem cells were less likely to be rejected as they are from the donor’s own body, unlike stem cells from embryos.
The University of Sheffield is a leading research university and ranked 40th in the World’s Top 100 Universities by one study.
At Michigan State University’s Cellular Reprogramming Laboratory researchers are conducting studies on transforming ordinary skin cells into “anything” cells, known as pluripotent cells. The research team at the Laboratory takes adult human skin cells and converts them to a stem cell type known as Induced Pluripotent Stem Cells. They then grow these cells under conditions that push the cells to adopt a new identity as cells of specific types, such as neurons.
One of the benefits of using skin is that it is the largest organ of the body – adults carry around 8 pounds and 22 square feet of it.
Neuralstem, Inc. (NYSE Amex: CUR) updated the progress of its ongoing Phase I human clinical trial of the company’s spinal cord stem cells in the treatment of ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig’s disease) at Emory University in Atlanta, Georgia. The company announced that, after reviewing the safety data from the first six non-ambulatory patients, the trial’s Safety Monitoring Board has unanimously approved moving to the next group of ALS patients, all of whom will be ambulatory.
