Archive by category | Clinical trials

More stem cells in Lou Gehrig’s disease

Shortly after my coverage of the FDA’s approval for NeuralStem’s stem-cell trial for amyotrophic lateral sclerosis appeared on the Niche, Letizia Mazzini and Franca Fagioli of Eastern Piedmont University contacted me to tell me about their team’s work using mesenchymal stem cells for the same disease. While Neuralstem is moving forward with neural stem cells, Mazzini and colleagues have been exploring the use of mesenchymal stem cells derived from the patient who will receive them. She has recently published results of a Phase I trial as well as a review of stem-cell approaches in ALS. Unfortunately, I learned of this work only after I’d posted.  Read more

FDA green lights stem-cell clinical trial for Lou Gehrig’s disease

The Maryland company NeuralStem has the U.S. Food and Drug Administration’s permission to test its spinal cord stem cells in twelve patients with amyotrophic lateral sclerosis. The approval comes a month after the FDA placed Geron’s planned clinical trial on hold for a second time. NeuralStem’s trial had also previously been placed on hold by the FDA in February before receiving the go-ahead in September.  Read more

More shots with mesenchymal stem cells

Yesterday, I reported on the failure of two late stage trials exploring mesenchymal stem cells to quell the potentally fatal immune response in graft versus host disease. Those trials were led by Osiris, a company in Maryland, which still hopes to look through its data and ongoing trials for signs of efficacy. See Stem-cell drug fails crucial trials  … Read more

Halt to clinical trial for simple cysts, not treacherous teratomas

Last week, the US Food and Drug Administration put the brakes on Geron Corp’s clinical trial in spinal cord injury because of just-completed animal studies that raised red flags. The Menlo, California-based biotech company announced Thursday that the animals developed microscopic cysts in the injury site. These lumps, however, did not spread to other parts of the body and none of the animals developed tumours. A second concluded study showed no cysts in spinal cord injured rats, according to a Geron press release.  Read more

First embryonic stem-cell trial placed on hold by FDA

Six months after giving it the green light, the U.S. Food and Drug Administration has told Geron to put plans for a clinical trial in spinal cord injury on hold. The company has differentiated embryonic stem cells into precursors of cells known as oligodendrocytes, which help keep neurons alive. Geron hopes this cell product could promote healing in people who have recently severed their spinal cords.  Read more

Round-up of regenerative medicine stories and a big, squeaking accomplishment

Two groups of researchers have at last completed a stringent test to show that induced pluripotent stem cells have the same developmental potential as embryonic stem cells: inserted into a special embryo, they can contribute to all the cells in a new mouse, litters of which have now been produced. (See the Nature news story)  … Read more

Stem-cell clinical trials set in India

Regulatory authorities in India have, for the first time, given the green light for clinical trials to test stem-cell products, according to an article in Nature Biotechnology. Sponsored by Stempeutics, those trials will test mesenchymal stem cells in patients who with critical limb ischemia or who have had heart attacks. Like a handful of other trials, these cells will be derived from the bone marrow of healthy donors, processed or expanded in vitro, and injected into diseased patients. (See Questioning the Self Cell)  … Read more

StemCells clinical trial results: Cells survive, seem safe

Transplants of a fetal neural stem cell product seem safe, according to a 12-month study on six children with a horrible neurodegenerative disease called neuronal ceroid lipofuscinosis or Batten disease. Furthermore, the company reported results from an autopsy of a treated patient who died from the disease. (See Girl dies in stem cell trial for Batten disease ). These indicate that the injected cells engraft and survive in the brain for close to a year.  Read more

After patient dies, Aastrom halts trial testing bone-marrow stem cells in heart disease

A patient death from unknown causes has led the company Aastrom to halt its clinical trial in which a mixed population of bone marrow cells is injected into patients’ heart muscle. The trial uses cells collected from the same patient who will receive the injection, and was examining the potential to treat heart failure caused by dilated cardiac myopathy.  Read more