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Stem Cell Clinical Trials: 11 Key Areas

What's happening as stem cell treatments are tested in people.

Diabetes

  • Goal: Use stem cells to outwit type 1 diabetes.
  • What's being done: Two different approaches are being explored. One is to use patients' own stem cells to make pancreatic cells, called beta cells, that can release insulin on demand for people with type 1 diabetes. If successful, the treatment could free patients from insulin injections.
  • Does it work: In an early study, the experimental procedure using patients' own stem cells, plus drugs to suppress the immune system, helped 15 teens with type 1 diabetes stay off insulin injections for about 1.5 years, on average. There were some side effects, most of which were temporary, and the study's small size means the results are preliminary. Clinical trials of the treatment using human embryonic stem cells have not begun.

Stroke

  • Goal: Use stem cells to offset brain damage done by stroke.
  • What's being done: A clinical trial is under way in Scotland. The trial, called "PISCES" (Pilot Investigation of Stem Cells in Stroke) involves 12 men who were disabled by stroke caused by a blood clot (the most common type of stroke). The researchers give the patients one brain injection of fetal neural stem cells 6-24 months after their stroke. The study is designed to test safety. If safe, the long-term goal is to repair tissue in the stroke-damaged areas of the brain and to reverse disabilities that can result from stroke (such as problems with movement, memory, attention, speech, language, or daily living). The U.K. company ReNeuron is doing this work.
  • Does it work? So far, the procedure appears to be safe. As of June 2012, six patients had gotten the stem cell injections. The therapy caused "no cell-related adverse events" and "no deterioration in the health of any of the patients," according to a news release from ReNeuron, the company doing the work. Another study is slated to start in 2013.

Spinal Cord Injury

  • Goal: Use stem cells to treat chronic spinal cord injury in patients with varying degrees of paralysis.
  • What's being done: A preliminary trial is under way, using adult neural stem cells. That trial is being done at Switzerland's University of Zurich and will involve 12 patients who have thoracic (chest-level) spinal cord injury. The stem cells will be directly transplanted into the patients' spinal cords. They'll be followed for 12 months after the procedure. A California biotech company, Geron, was testing using human embryonic stem cells to restore spinal cord function in patients with recent spinal cord injuries. But Geron discontinued the study in November 2011 when it ended all of its stem cell programs to focus on cancer programs.
  • Does it work? So far, there's no proof of lasting effect. In 2009, scientists at the University of Sao Paulo School of Medicine in Brazil published a study involving 39 patients with chronic spinal cord injury. They took stem cells from the patients' blood and delivered the cells back into the femoral artery in the patients' legs. The therapy was safe and 26 of the patients (66%) showed some improvement in responding to stimuli, the researchers reported in the journal Spinal Cord. But ultimately, the therapy hasn't yet shown much effectiveness, according to a stem cell trial review published in 2011 in BMC Medicine.

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