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The spinal cord injuries must be American Spinal Injury Association (ASIA) grade A or B. Study participants must be age 18 or older and have experienced traumatic spinal cord injury within the past year. Patients randomized to the medical management arm will eventually cross over to the stem cell arm. In CELLTOP phase 2, 40 patients will be randomized to receive stem cell treatment or best medical management. "One objective in our future studies is to delineate the optimal treatment protocols and understand why patients respond differently." Among the 10 participants in our phase 1 study, we had some nonresponders and moderate responders," Dr. "Not every patient who receives stem cell treatment is going to be a superresponder.
#Stem cell treatment for spinal cord injury trial
The first participant in the phase 1 trial was a superresponder who, after stem cell therapy, saw significant improvements in the function of his upper and lower extremities. Bydon examining patient #1 in the CELLTOP phase 1 trial “We want to do our best to establish safety and provide the treatment to patients.Dr. Finally we can start a clinical trial,” Okano said at a news conference in Tokyo. “It’s been 20 years since I started researching cell treatment. Research team leader, Professor Hideyuki Okano, has published work in PLOS ONE describing the efficacy of a stem cell treatment tested in a non-human primate model, whereby the cells were transplanted into the cervical spinal cord. “The fact that the cells are trapped in the lungs makes it difficult to see how they can be effective in the spinal cord,” -Pamela Robey, a stemcell researcher at the US National Institutes of Health in Bethesda, Maryland.
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The Japan Times reported that the approach has enabled a paralyzed monkey to walk again, and noted that Kyoto University’s Shinya Yamakana won the Nobel Prize in physiology/medicine for his work in regenerative medicine, where he developed induced pluripotent stem cells. 12 of the 13 regained some lost sensation and movement. However, Nature report that the results describe a trial of 13 people who received intravenous infusions of stem cells extracted from their own bone marrow. The work paving the way for the proposed trial has not yet been published. While these milestones are significant for the field, they are a far stretch from demonstrating efficacy of such a treatment, and independent researchers warn that the approval is premature. Human induced pluripotent stem cell-derived neurons grafted into rodents suppressed epileptic seizures.Bioengineered spinal discs implanted into goats showed promise.A biodegradable nanoscaffold was developed for the transplantation of stem cells into the spinal cord and was shown to be a viable approach in animal models.Significant progress has been made in the regenerative medicine/CNS space in the last 12 months: The work is being lead by a research group from Keio University. The participants must have sustained a spinal cord injury 2-4 weeks prior, and must have lost mobility and sensory functions as a result. Therefore, four candidates will be selected for a trial, following the approval by Japan’s Health Ministry on Monday. The country has unique regulations for the approval of regenerative medicines - therapies can be sold even if they show only hints of efficacy, on the condition that follow-up data is collected.
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Japan has given a stem cell therapy the "green light" for the treatment of spinal cord injuries in humans.