Rush University Medical Center is seeking patients for a new stem cell trial that has already shown promising results, according to a September RUMC news release. The hospital seeks patients ages 18 to 65 who recently experienced a complete spinal cord injury.
As part of a multicenter clinical trial, doctors at Rush became the first in Illinois to inject AST-OPC1 cells, derived from embryonic stem cells, into a recently paralyzed man, according to the release. So far, Rush has injected three patients who lost sensation and movement below their injury site, with severe paralysis of the upper and lower limbs. The cells are injected 14 to 30 days post injury, and patients are then followed by neurological exams and imaging to assess product safety.
“We may be on the verge of making a major breakthrough after decades of attempts,” Richard G. Fessler, MD, PhD, professor of neurological surgery at Rush, said in the release. “In the 20 years of my research, we have now reached a new era where we hope to demonstrate through research that a dose of very specially made human cells delivered directly to the injured site can have an impact on motor or sensory function.”
After only three months into the trial, all patients have shown at least one motor level of improvement, according to a press release from Asterias Biotherapeutics, the company that developed the cell treatment. Two cohorts were injected with the cells. One received an injection of 2 million cells and the other received 10 million. A third cohort is planned for 2017 and will receive 20 million cells, the AB press release stated.
“The results to date in the 10 million cell cohort, while still early, demonstrate meaningful improvement in motor function, particularly in the use of a patient’s hands, fingers and arms, which is critically important for a patient’s quality of life and ability to function independently,” Steve Cartt, CEO of Asterias, stated in the AB press release. “We are quite encouraged by this first look at efficacy results and look forward to reporting six-month efficacy data as planned in January 2017.
Results of interim research were presented at the 55th annual Scientific Meeting of the International Spinal Cord Society in Vienna.
“Until now, there have been no new treatment options for the 17,000 new spinal cord injuries that happen each year,” Fessler said.
According to the RUMC press release, AST-OPC1 cells are made from embryonic stem cells by carefully converting them into oligodendrocyte progenitor cells, cells that support nerve function. Previous lab studies demonstrated improvement, according to Edward D. Wirth III, MD, PhD, who is the lead investigator for the study.
Asteria Biotherapeutics is just one of a few companies involved with clinical trials for spinal cord injuries, according to the United Spinal Association.
In the post, “Exciting Times for Spinal Cord Injury Clinical Trials,” the USA website talks about the success of transplanting Schwann cells into a patient in August of 2015; an ongoing neural stem cell trial being conducted at the University of Miami; and Neuralstem’s study which began neural stem cell surgeries back in 2014 in California.
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