Pathway SCI Stem Cell Trials Shut Down Abruptly


James-Mason
Stem Cells, Inc. is shutting down its promising Pathway SCI stem cell trials as reported improvements from participants are “not big enough” for investors.

Stem Cells, Inc. is shutting down its promising Pathway SCI stem cell trials as reported improvements from participants are “not big enough” for investors.

On May 31, in a press release that shocked the SCI and research communities, Stem Cells, Inc. announced it was shutting down its Pathway SCI research trials using adult neural stem cells. These were the same trials that participants reported seeing promising results from, such as increased hand function and better bladder control.

[“Stem Cell Trials Show Improved Hand Function, Sensation and Bladder Awareness,” June 2016].

Less than one month earlier, Stephen Huhn, the company’s lead researcher and chief medical officer, had told New Mobility that he was optimistic about the trials, saying, “We will be enrolling more subjects in the ongoing trials at least through September.” But the company’s board of directors, after revisiting outcome data and “given the financial resources available to the company,” decided to close down the trials.

Kim Anderson-Erisman, Ph.D, associate professor, department of neurological surgery, Miami Project to Cure Paralysis, was surprised by the announcement. “It was a shock to us [and] … we’re one of the top sites in the study. The sad part is they did an interim analysis on a subset of the subjects enrolled in the randomized cohort and they saw improvement in the treatment group compared to the control group, but not a ‘big enough’ improvement for their investors to continue their funding. It’s disappointing because even small improvements can have a significant impact on the lives of people living with SCI.”

Irv Massey, president and CEO of Stem Cells, Inc., said the company “hoped to be the first clinical program involving cellular transplantation to meaningfully improve motor function in patients with chronic spinal cord injury.” Huhn had told New Mobility earlier that the results were more encouraging with ASIA B (motor complete, sensory incomplete) than with ASIA A (motor and sensory complete) spinal cord injuries.

The trial results, according to Huhn, were still encouraging. “There are neurological and retinal disorders with unmet need that may be helped by cell transplant. Unfortunately,” he added, “the company does not have the resources to implement changes in our development program to permit further investigation.”

In addition to closing down the Pathway trials, the press release also stated that the board of directors had approved a plan to “wind down the company” and that “it is possible that there will be no liquidating distribution to stockholders.”


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