SAN FRANCISCO (KGO) Bay Area stem cell researchers are reporting early, encouraging results from two clinical trials. The first, involves patients, paralyzed with spinal cord injuries and a treatment that could offer new hope for their future.
Nearly 20 years after the football injury that left him paralyzed, Roman Reed still holds onto the hope that he will someday walk again.
“One hundred percent, without a doubt. I’ve been wrong about the date, but not the fact I will walk again,” said Reed.
Reed now runs a foundation to promote stem cell research and has been closely watching a clinical trial being conducted by Bay Area based Stem Cells Inc. Its goal is to use stem cell therapy to restore motor function in patients with spinal cord injuries.
“We’re on the road on to being able to cure paralysis, it’s so important, and stem cells are the way to do it,” said Reed.
Stephen Huhn, M.D., Ph.D., from Stem Cells Inc., says the test procedure began a two hour surgery to clear a path to the spinal cord. Researchers then injected the cells directly into the damaged area.
“So the first three patients in the trial were designed to enroll patients who had the worst of the worst injuries. In other words, complete loss of sensory function and complete loss of motor function below the level of injury,” said Huhn.
The phase one trials are all about establishing safety, but six months out, the researchers began measuring some intriguing improvements in two of those three patients. Both reported feeling in areas below the areas of their injuries.
The company cautions that the data is very preliminary, but they say researchers were able to measure the improved sensory response using several testing methods, including electrical stimulation, and response to heat — which are considered more accurate than the patient’s own self-reporting.
“You can’t fake that. When we saw that data, that’s when we became very excited,” said Martin McGlynn, the CEO of Stems Cells Inc.
The technique had shown preliminary success in animal models. In a video provided by Stem Cell Inc., a mouse with a spinal cord injury is barely able move its back legs as it struggles forward. But after being treated with stem cells, the same animal eventually regained its normal gate. McGlynn believes success in the early human trials could move the research ahead at a much faster pace.
“In the world of clinical trials and in the world of regulatory affairs, human data typically trumps animal data,” said McGlynn.
In July, CIRM the California Institute for Regenerative Medicine approved funding for Stem Cells Inc. to begin a more advanced trial with UC Irvine. That study, if approved by the FDA, would concentrate on the neck — the most common area for spinal cord injuries. That’s the same injury that left Reed with the prognosis of never walking again.
“I didn’t accept that then and I don’t accept it now. Stem cells, research are the way that we will be cured,” said Reed.
There is encouraging news from a second trial as well, also involving Stem Cells Inc. and UCSF’s Benioff Children’s Hospital. Researchers there injected stem cells into children with a deadly brain condition called PMD. The disease destroys the insulation around nerve pathways — known as the myelin sheath.
The UCSF team found the transplanted stem cells generated fresh myelin. They also noted some improvement in neurological function, but say it’s too early to know for certain if that was a result of the stem cell treatment.
Roman Reed, Dr. Stephen Huhn, and Martin McGlynn will be at the Working 2 Walk Symposium along with a number of other leading advocates and researchers. Join us on November 1-2 at the Hilton Hotel, Irvine, CA.