Category Archives: Stem Cell Human Trials

Stem cell transplantation study for the treatment of ALS Phase 2 The phase 2 trial focused on the safety and maximum tolerated dose of Human Spinal Cord Derived Neural Stem Cell Transplantation. This study expanded on the work of the phase 1 study directed by Eva L. Feldman, M.D., Ph.D., who is the principal investigator and director of the first-ever FDA-approved human clinical trial of stem cells injected directly into the spinal cords of ALS patients. Phase 1 of the trial, designed to study the safety of the procedure, was completed in 2013 with no significant adverse side effects to patients. And follow-up patient evaluations have produced some extraordinary data: Several participants in the trial, who were treated early in their disease, were determined to have had little or no significant progression of ALS for more than 700 days post-surgery. Updated July 2015: Fifteen patients were studied in the phase 2 study, the last 3 of which received 8 million stem cells injected into the lumbar spinal cord followed by 8 million stem cells injected into the cervical spinal cord. All procedures have been completed and the trial is still ongoing. No data has been released. https://clinicaltrials.gov/show/NCT01730716 Future trials Updated … Continue reading →

Dec. 20, 2014 Government-backed Japanese institute Riken accepts resignation of Haruko Obokata, one of its highest-profile scientists, after she fails to replicate research results that were once hailed as breakthrough in stem cell research. MORE Experimental stem cell procedures, once talked about but not put into practice, are starting to be used in trial settings; as many as 4,500 clinical trials involving stem cells are under way in United States to treat patients with conditions such as heart disease, blindness, Parkinson's and spinal cord injury; enthusiasm for such procedures, however, sometimes outstrips supporting science. MORE Colleagues of Yoshiki Sasai, leading Japanese life science researcher, say he has taken his own life; Sasai was co-author of discredited stem cell study published in journal Nature that was retracted due to factual errors and allegations of misconduct. MORE Journal Nature retracts two scientific papers it published that initially electrified biologists by describing easy way to make stem cells; says papers were error-filled and had not been verified by anyone else. MORE Op-Ed article by evolutionary geneticist Svante Paabo warns against using sequenced genomes of Neanderthals to re-create Neanderthal individuals; contends from an ethical perspective such an idea should be condemned, and argues that … Continue reading →

Blood cells grown in culture (reticulocytes) The first human trials of lab-produced blood to help create better-matched blood for patients with complex blood conditions has been announced by NHS Blood and Transplant. Research led by scientists at the University of Bristol and NHS Blood and Transplant, used stem cells from adult and umbilical cord blood to create a small volume of manufactured red blood cells. It is hoped that when the production of this lab-produced blood is successfully scaled up, it will offer an alternative to specialist patients with blood disorders such as sickle cell anaemia and thalassemia who require treatment with regular transfusions and for whom it is difficult to find compatible donors. The clinical trial of manufactured red blood cells is designed to compare the survival of red cells manufactured from stem cells with that of standard blood donor red blood cells. This will involve a group of 20 volunteers who will receive a small volume transfusion of between five and ten mls of the lab-produced blood. Dr Ashley Toye from Bristol's School of Biochemistry, who worked alongside Professor Dave Anstee from NHS Blood and Transplant Blood on the project, said: "This announcement is an important stage in … Continue reading →

The news that legendary Green Bay Packer quarterback Bart Starr has undergone stem cell therapy to recover from a stroke has raised the profile for a promising but unproven regenerative treatment intended to replace dead neurons with live ones. The University of Wisconsin-Madison's Su-Chun Zhang was the first scientist to isolate neural stem cells from embryonic stem cells and then from other types of all-purpose stem cells. He says medical researchers and the federal government have a responsibility to forge ahead with clinical trials to prove whether and how these flexible cells can replace damaged or dead neural cells caused by spinal cord injury, stroke and Lou Gehrig's disease (ALS). Su-Chun Zhang "We have no effective treatment for stroke," says Zhang, a medical doctor and Ph.D. researcher at the UW's Waisman Center. "After a couple of hours, the cells are dead if they don't have a blood supply. And the brain has a very limited capacity to regenerate, particularly in older patients." Embryonic stem cells the cells that give rise to all body tissues were first cultured by James Thomson at UW-Madison in 1998. Just three years later in 2001 Zhang discovered how to grow neural cells from embryonic stem … Continue reading →

You may also like.... Kadimastem To Initiate a Human Clinical Trial for Promising ALS Therapy FDA Controversy Over ALS Drug Trial Highlights Urgent Need For Further Research ALS Study Shows Benefits of NurOwn Stem Cell Therapy Q Therapeutics, Inc., a company focused on adult stem cell therapies for disorders of the central nervous system, recently announced that its product Q-Cells has received Investigational New Drug (IND) clearance by the U.S. Food and Drug Administration (FDA) for the start of Phase 1/2a clinical trials in humans to evaluate the safety and tolerability of Q-Cells in patients with amyotrophic lateral sclerosis (ALS). ALS is a progressive neurodegenerative disease, characterized by the gradual degeneration and atrophy of motor neurons in the brain and spinal cord that are responsible for controlling essential voluntary muscles, such as the ones related to movement, speaking, eating, and even breathing. ALS patients may become totally paralyzed and the majority dies due to respiratory failure within two to five years after diagnosis. It is estimated that more than 300,000 Americans suffer from the diseaseforwhichthere is currently no cure. Q-Cells corresponds to a cell-based therapeutic product candidate designed to preserve or restore the normal neural activity. It is based on … Continue reading →

Two patients with two different forms of vision loss will soon start treatments made from embryonic stem cells as Advanced Cell Technology kicks off two early-stage clinical trials using the controversial and powerful cells. The patients were enrolled at the Jules Stein Eye Institute at the University of California, Los Angeles, Advanced Cell said on Thursday. It did not release the patients' names. The company won U.S. Food and Drug Administration approval in January to try out human embryonic stem cells for treating macular degeneration, a common cause of vision loss. That followed FDA approval in November to test human embryonic stem cells to treat people with a progressive form of blindness called Stargardt's macular dystrophy. Both trials will test the safety and tolerability of retinal pigment epithelial, or RPE cells, which ACT makes from human embryonic stem cells. Each study will enroll 12 patients, with groups of three testing different doses of the cells. Dr. Robert Lanza, chief scientific officer of ACT, said in an email that the company planned to start stem cell transplants within the next few weeks. "After a decade of extensive research and preclinical studies, it is very satisfying to finally be moving into the … Continue reading →

Progressive multiple sclerosis is a particularly horrendous and intractable illness. Unlike the relapsing remitting form of the disease, for which there are currently 12 approved treatment options (however imperfect these may be), there is tragically little available for progressive MS patients (one very flawed treatment option for SPMS and none for PPMS). At the recent American Academy of Neurology meetings, held last week in Washington DC, some rays of hope for progressive MS finally shone through, among them studies done on honest-to-goodness human progressive MS patients as opposed to those done on mice or in test tubes that show particular promise. As Ive written about extensively (click here ), the Tisch MS Research Center of New York is currently conducting the only FDA approved regenerative human stem cell trial on MS patients in the United States. Yes, this is the very same study that the National Multiple Sclerosis Society has repeatedly refused to fund (click here). Though this phase 1 trial is not yet complete, interim results were released at the AAN meeting, and they look impressive. The Tisch Center utilizes a unique approach to using stem cells to treat MS, quite unlike the techniques used in previous regenerative stem … Continue reading →

SALT LAKE CITY, Utah - Rachel Taylor was diagnosed with multiple sclerosis 14 years ago. "It was terrifying. It was like having a wet, heavy blanket put over your life. I was active. I was a runner. I was outdoors playing, and over the course of a few months, I couldn't figure out why I couldn't keep up" Taylor recalled. Taylor knew what was wrong. She'd been working with the MS Society bike rides for years. Taylor is in remission now, but she is still thrilled with Tom Lane, professor of pathology at the University of Utahs stem cell discovery. "We have animals that are paralyzed that cannot right themselves, and once we engraft the neural stem cells into the spinal cords, within three weeks, the majority of the animals, about 80 to 85 percent, will regain motor skills," Lane said. Researchers said MS damages myelin, a layer around nerve cells. Once injected, the human neural cells stimulate the mouse's own cells to repair the damage. When nerve cell function returns, the mice can walk and run again. Taylor said the discovery could be life-changing for many of her friends. Researchers said after the mice regained function, their bodies rejected … Continue reading →

SAN DIEGO. (Ivanhoe Newswire) -- According to the Christopher and Dana Reeve Foundation, nearly one in 50 people is living with paralysis. Until now, there wasn't much hope. But a new study involving stem cells has doctors and patients excited. Two years ago, Brenda Guerra's life changed forever. Guerra told Ivanhoe, They told me that I went into a ditch and was ejected out of the vehicle. The accident left the 26-year-old paralyzed from the waist down, and confined to a wheelchair. I don't feel any of my lower body at all she said. Guerra has traveled from Kansas to UC San Diego to be the first patient to participate in a ground-breaking safety trial, testing stem cells for paralysis. Joseph D. Ciacci, MD, Professor of Neurosurgery at UC San Diego told Ivanhoe, We are directly injecting the stem cells into the spine. The stem cells come from fetal spinal cords. The idea is when they're transplanted they will develop into new neurons and bridge the gap created by the injury by replacing severed or lost nerve connections. They did that in animals and doctors are hoping for similar results in humans. The ultimate goal is to help people like … Continue reading →

Multiple sclerosis (MS) is a scary and unpredictable disease. A patient's own immune system attacks the nervous system; causing numbness, dizziness and in some cases paralysis. "It was terrifying, said Rachel Taylor. It was like having a wet, heavy blanket put over your life." Taylor was diagnosed with MS 14 years ago. "I was an active runner, and over the course of a few months couldn't figure out why I couldn't keep up," said Rachel. Rachel knew what was wrong; she'd been working with the MS Society bike rides for years. Rachel's in remission now, but she is still thrilled with Prof. Tom Lane's stem cell discovery. "We have animals that are paralyzed that cannot right themselves, and once we en-graft the neural stem cells into the spinal cords, within three weeks, the majority of the animals, about 80 to 85 percent, will regain motor skills," said Prof. Tom Lane, PhD, a professor of Pathology at the University of Utah. Researchers say MS damages the myelin, a layer around nerve cells. Once injected, the human neural stem cells stimulate the mouse's own cells to repair the damage. When nerve cell function returns, the mice can walk and run again. Continue … Continue reading →