Category Archives: Stem Cell Human Trials

Stanford Report, January 6, 2014 Irving Weissman, director of the Ludwig Center for Cancer Stem Cell Research and Medicine at Stanford. The Stanford University School of Medicine has received $90 million from Ludwig Cancer Research on behalf of its founder, Daniel K. Ludwig, to support the school's innovative work in cancer stem cells, which are believed to drive the growth of many cancers. Stanford is one of six institutions to share in Ludwig's $540 million contribution to the field of cancer research. Announced today, the gift is one of the largest ever made to the field from an individual donor. The funding will augment the existing endowment for the Ludwig Center for Cancer Stem Cell Research and Medicine at Stanford, established in 2006, where scientists already have discovered some promising therapies that are moving into clinical trials. "The gift from Ludwig Cancer Research is truly historic," said Stanford President John Hennessy. "Over the years, Ludwig has been a generous supporter of cancer research, and through its support changed the course of cancer treatment. But this extraordinary gift will spur innovation well into the future.Stanford is distinguished for its cancer research and has assembled a 'dream team' of dedicated scientists at … Continue reading →

Cofounder of Stem Cell Theranostics and StartX Med Divya Nag is attacking one of medicine's biggest problems: the fact that most types of human cellslike those in the heart or liverdie when you keep them in a petri dish. This makes testing new drugs a risky, costly and time-consuming business: 90% of medicines that start clinical trials turn out to be too unsafe or ineffective to market. But a new technology, the induced pluripotent stem cell, may help. Nag's company, Stem Cell Theranostics, was created from technology funded by a $20 million grant from the California Institute of Regenerative Medicine and is closing a venture round. It turns cellsusually from a piece of skininto embryonic-like stem cells, then uses them to create heart cells. These cells can live in petri dishes and be used to test new drugs. Someday they might even replace heart tissue that dies during a heart attack. Three large pharmaceutical companies are customers, though revenues are small. Nag, who was already publishing in prestigious scientific journals when she was an undergraduate, dropped out of Stanford to pursue her dream. No regrets: "Our technology was so promising and I was so passionate about it that nothing else … Continue reading →

This is an annual report of registered clinical trials in cell therapy. Every year I overview some tracked data from international clinical trials databases. You can see 2011 report here. Definitions I tracked clinical trials which fall in definition of cell therapy: administration of living cells in human with therapeutic purpose. I included tissue engineering, cellular gene therapy and devices for cell processing. I tracked all clinical trials which were registered from Jan.1, 2012 to Dec. 31, 2012 in international databases. Exclusion criteria: Trials, assessing cell therapy for homologous use were excluded from analysis. Examples: (1) hematopoietic cells for recovery of blood formation (in hematological malignancies) or (2) ex vivo expansion of hematopoietic cells for enhancement of engraftment in hematological malignancies. Hand coding and data collection Hand coding included: Search key words: cell therapy stem cell cord blood umbilical cord bone marrow cancer vaccine tissue engineering Total number of trials tracked: 226 Number of duplications between databases: 6 Databases The following databases were scanned: US NCT (NIH-FDA) European EUCTR Japanese JPRN Indian CTRI Chinese ChiTCR Iranian IRCT Australian/NZ ANZCTR UK ISRCTN Dutch NTR South Korean CRIS All international databases, except NCT, were scanned via WHO Search Portal. Databases representation: Demographics: … Continue reading →

By Scott M. Lippman Chemotherapies seek out cancer cells by targeting a fundamental characteristic of cancer cells: their rapid and frequent replication. But in doing so, these drugs can destroy healthy cells that also grow quickly. The result: adverse effects like hair loss and nausea.Worse, the benefits of chemotherapy are frequently short-lived. Seemingly beaten by chemotherapy, a cancer can suddenly return, spreading from its original site to other parts of the body with often catastrophic consequences. Ninety percent of cancer-related deaths are due to metastasis, and almost every cancer can be metastatic. Why do cancers recur when therapeutic evidence suggests theyve been wiped out? The answer lies in a type of cancer cell with the powerful characteristic of normal stem cells the ability to self-renew or regenerate. Sott M. Lippman, M.D. Unlike normal stem cells, however, this ability in cancer stem cells does not turn off. Cancer stem cells are a relatively new phenomenon to cancer science. Conclusive evidence of their existence was found only in 1994, though in the years since, extraordinary efforts have been made to better understand them in order to destroy them. Its a daunting task. Cancer stem cells persist in small communities, often tucked away … Continue reading →

Primary Outcome Measures: Safety [TimeFrame:Through 2 years] [Designatedassafetyissue:Yes] Secondary Outcome Measures: Pulmonary Function Tests [TimeFrame:Through 1 year] [Designatedassafetyissue:No] Exercise Capability [TimeFrame:Through 1 year] [Designatedassafetyissue:No] Quality of life [TimeFrame:Through 1 year] [Designatedassafetyissue:No] COPD is currently the fourth leading cause of death in the United States. It is clear that there is a significant unmet medical need for safe and effective therapies to treat moderate to severe COPD. This patient population has a high mortality rate and requires frequent hospitalizations due to disease-related exacerbations. Based on severity distribution estimates, approximately 70% of all current COPD patients have either moderate or severe COPD. COPD has no known cure, thus current therapeutic intervention is aimed at providing relief of symptoms. Oxygen therapy is the only treatment that has been shown to improve survival. Smoking cessation has been shown to slow the rate of FEV1 decline and COPD progression. In general patients are treated with bronchodilators and inhaled corticosteroids, but again, these measures do not provide any significant benefit regarding disease progression or prognosis. The characteristics and biologic activity of PROCHYMAL, along with a good safety profile in human trials to date, suggest that PROCHYMAL may be a good candidate for addressing this unmet medical … Continue reading →

CD47 is a kind of protein that is found on the surface of many cells in the body. It tells circulating immune cells called macrophages not to eat these cells. The body uses the CD47 protein to protect cells that should be protected and to help dispose of cells that are aged or diseased. For instance, red blood cells start off with a lot of CD47 on their cell surface when young but slowly lose CD47 as they age. At some point, the amount of CD47 on the surface of an aging red blood cells is not enough to stave off the macrophages, and those older cells are devoured and destroyed, making way for new red blood cells. In this way, the supply of fresh blood cells is constantly replenished. Unfortunately, some cells that should be destroyed are not. Researchers at Stanford have discovered that nearly every kind of cancer cell has a large amount of CD47 on the cell surface. This protein signal protects the cancer against attack by the body's immune system. Stanford investigators have discovered if that they block the CD47 "don't-eat-me" signal through the use of anti-CD47 antibodies, macrophages will consume and destroy cancer cells. Deadly … Continue reading →

On December 12, UCLA announced that two prominent UCLA stem cell researchers have received awards from the California Institute of Regenerative Medicine (CIRM), the state stem cell agency. The awards will fund two clinical trials scheduled to begin in 2014: (1) the Binational Phase I clinical trial to test a targeted anti-cancer drug has been approved to enroll patients in US and Canada; and (2) the first in-human testing of stem cell gene therapy for sickle cell disease that allows patients to be their own bone marrow donors. The announcement of the new awards was made at the meeting of the CIRM Independent Citizens Oversight Committee (ICOC) at the Luxe Hotel in Los Angeles The recipients of the awards, the Disease Team Therapy Development III awards, were Dr. Dennis Slamon, Dr. Zev Wainberg, and Dr. Donald Kohn. Drs. Slamon and Winbergs phase I clinical trial will test a new drug that targets cancer stem cells and has been approved to begin enrolling patients in the US and Canada. Dr. Donald Kohn will conduct the first-in-human trial on stem cell gene therapy for sickle cell disease. At the awards ceremony, Dr. Owen Witte, Director of the UCLA Broad Stem Cell Research … Continue reading →

We are currently conducting or have completed clinical trials of our proprietary HuCNS-SC product candidate (purified human neural stem cells) in spinal cord injury, dry age-related macular deneneration, and intwo fatal neurodegenerative disorders: InDecember 2010, wereceived authorization from Swissmedic, the Swiss regulatory agency for therapeutic products, to initiatea Phase I/II clinical trial of our HuCNS-SC cells in chronic spinalcord injury. The trial initiated in March 2011 and iscurrently open forenrollment. The trial is beingconductedinSwitzerland at the Balgrist University Hospital, University of Zurich. Learnmore The trial is designed to assess both safety and preliminary efficacy in patients with varying degrees of paralysis who are three to 12 months post-injury, and will progressively enroll patients based upon the severity of injury. The trial will enroll 12 patients in Europe with thoracic (chest-level) spinal cord injury, and will include both complete and incomplete injuries as classified by the American Spinal Injury Association (ASIA) Impairment Scale. The first cohort will include patients classified as ASIA A. These patients have what is considered to be a "complete" injury, or no movement or feeling below the level of the injury. The second cohort will progress to patients classified as ASIA B, or patients with some degree … Continue reading →

Contact Information Available for logged-in reporters only Newswise Stem cell researchers from UCLAs Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research have published the first study to identify the origin cells and track the early development of human articular cartilage, providing what could be a new cell source and biological roadmap for therapies to repair cartilage defects and osteoarthritis. These revolutionary therapies could reach clinical trials within three years. Led by Dr. Denis Evseenko, assistant professor of orthopedic surgery and head of UCLAs Laboratory of Connective Tissue Regeneration, the study was published online ahead of print in Stem Cell Reports on December 12, 2013. Articular cartilage is a highly specialized tissue formed from cells called chondrocytes that protect the bones of joints from forces associated with load bearing and impact, and allows nearly frictionless motion between the articular surfaces. Cartilage injury and lack of cartilage regeneration often lead to osteoarthritis involving degradation of joints, including cartilage and bone. Osteoarthritis currently affects more than 20 million people in the United States alone, making joint surface restoration a major priority in modern medicine. Different cell types have been studied with respect to their ability to generate articular cartilage. … Continue reading →

Californias government-run stem-cell research agency, on course to spend $3 billion in taxpayer money to find treatments for some of the worlds most intractable diseases, is pushing to accelerate human testing before its financing runs out. For the California Institute for Regenerative Medicine, time is growing short to fund research that demonstrates the potential of stem cells to help treat everything from cancer to heart disease to spinal cord injuries. The agency, created by voters in 2004, has given out more than half of its $3 billion from state bonds and must spend the rest by 2017. The largest U.S. funding source for stem-cell research outside the federal government, its under pressure to show results to attract new money from pharmaceutical companies, venture capitalists or even more municipal bonds. We need to figure out how to keep them going, said Jonathan Thomas, a founding partner of Saybrook Capital LLC in Los Angeles, and chairman of the institutes board, which meets today. We could do public-private partnerships, venture philanthropy, a ballot box. Embryonic stem cells have the potential to change into any type of cell in the body. They are among the first cells created in embryos after conception. Scientists hope … Continue reading →