Trial Shows Gains in Sensory Function

Reprinted from PN/Paraplegia News May 2013

Stem cells continue to be a major player in research to find a cure for spinal cord injury. A patient in one study is showing promising signs.

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StemCells, Inc. announced earlier this spring that gains in sensory function by the first patient cohort in a clinical trial were maintained 12 months after having a stem cell transplant.

The patient was taking part in the company’s Phase I/II clinical trial of its proprietary HuCNS-SC product (purified human neural stem cells) for chronic SCI.

Very Encouraging

The company says the patient continued to demonstrate a favorable safety profile after one year.

StemCells also says the patient showed that the considerable gains in sensory function observed in two of three patients at the six-month assessment have persisted. The third patient remains stable.

By completing the 12-month assessment, the first patient cohort has now finished the trial and has entered into a separate follow-up study for long-term observation.

Long-term gains are being seen in a human neural stem cell study.

“The multi-segment gains observed in sensory function in two patients at six months have endured at the 12-month assessment,” says Armin Curt, MD, professor and chairman of the Spinal Cord Injury Center at Balgrist University Hospital at the University of Zurich in Switzerland and principal investigator of the clinical trial. “In addition, between the six- and 12-month evaluations, one patient converted from a complete to an incomplete injury.”

Curt says the sensory gains seen at the end of the study were present in more than one clinical measure. He adds that more research is needed but calls the changes they’re seeing “unexpected” and “very encouraging.”

Positive Changes

Patients in the study’s first cohort each sustained a complete injury to the thoracic (chest level) spinal cord.

In a complete injury, there is no neurological function below the level of injury, and sensory function of all three patients was stable before transplantation of the HuCNS-SC cells. 

All three patients were transplanted four to nine months after injury with a dose of 20 million cells at the injury site. The surgery, immunosuppression and the cell transplants have been well tolerated by all the patients. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients remained neurologically stable through the first 12 months following transplantation. 

Positive changes in sensitivity to touch, heat and electrical stimuli were observed in well-defined and consistent thoracic regions in two of the patients, while no changes were observed in the third patient.

Importantly, quantitative tests of specific sensory function, as well as electrophysiological measures of impulse transmission across the site of injury, show an association with the clinical examination, providing further objective confirmation of the sensory gains.

 “While we need to be cautious when interpreting data from a small, uncontrolled trial, to our knowledge this is the first time a patient with a complete spinal-cord injury has been converted to a patient with an incomplete injury following transplantation of neural stem cells,” says Martin McGlynn, StemCells president and CEO. “We are encouraged that the cells appear to convey clinical benefit in such severely injured patients.”

Safety & Capability

The Phase I/II clinical trial of HuCNS-SC is designed to assess safety as well as preliminary capability.

Twelve patients with chest-level neurological injuries at the T2–T11 level are planned for enrollment. Their injuries must have occurred within three to 12 months prior to transplantation of the cells. 

The trial will make assessments based on defined clinical endpoints, such as changes in sensation, motor function and bowel/bladder function.

The company has dosed the first three patients, all of whom have injuries classified as “A” on the American Spinal Injury Association Impairment Scale (AIS). That means there is no neurological function below the injury level.

The second and third cohorts will be patients classified as AIS B and AIS C, those with less severe injury, in which there is some preservation of sensory or motor function.

Greater Benefits?

All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. 

Patients will be evaluated regularly in the post-transplant period. They’ll be monitored to assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. 

StemCells says it intends to follow the effects of this therapy long-term, and each of the patients will be invited to enroll in a separate four-year observational study after completing the Phase I/II study. 

“We are therefore hopeful that we will see similar or greater benefit in AIS B and C patients, who already have partial sensation and motor function below the level of injury, which could be further augmented by cell transplantation,” says McGlynn.

Enrollment for the second cohort is currently underway, and the first AIS B patient was enrolled and dosed late last year.

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