Clinical Trials: Translating Research to Benefit Patients

"We're in the Hope Business"

Lucas Lindner and Dr. Shekar Kurpad shake hands
Lucas Lindner, paralyzed in an automobile accident in May 2016, has regained some fine motor actions of his arms, hands and fingers following a clinical trial involving surgery and based on Dr. Shekar Kurpad's research into cellular transplantation for spinal cord injury.

Twenty-two-year-old Lucas Lindner of Eden, Wisconsin, was on a routine trip to the grocery store one Sunday morning in May 2016 when a deer unexpectedly jumped into the path of his car, causing a serious accident. In mere minutes, Lindner went from having an active life as a technical college student and manager for McDonald's to total paralysis below the site of his C5-C6 cervical spinal cord injury.

Flight for Life airlifted Lindner to Froedtert Hospital, where, upon awaking several days later, he was able only to shrug his shoulders, use his biceps in a crude fashion, wriggle his wrists and bring his hands to his mouth, according to his surgeon, Shekar N. Kurpad, MD, FEL '01, PhD, interim chair and professor of neurosurgery at the Medical College of Wisconsin (MCW), and director of the Froedtert & the Medical College of Wisconsin's Spinal Cord Injury Center. Lindner could not master fine motor skills such as writing, holding small items, buttoning clothes, eating or using a computer keyboard. He was despondent, noting that "everything I was working on in my life was lost.'

Dr. Shekar Kurpad's spinal researchDr. Kurpad, however, had reason to offer hope. Lindner was a candidate for a new clinical trial based on 15 years of Dr. Kurpad's research into cellular transplantation for spinal cord injury. The timing was ideal, as the surgery – injection of stem cells (cells with the potential to develop into many different types of cells in the body) into the spinal cord – needed to be conducted within 30 days of the injury (once the inflammation had lessened). Lindner was to be the first patient in this exciting clinical trial undertaken by Dr. Kurpad and his team of Froedtert & the Medical College of Wisconsin healthcare providers, and built on a solid foundation of MCW's bench research.

But would it restore Lindner's ability to live a more independent life?

Less than three months later, Lindner was able to use his arms and fingers to perform the fine motor actions he needs to feed and dress himself – and perhaps most importantly, to type on a keyboard. He continues to recover function and movement, and is focusing on gaining strength and dexterity. "I'm reaching a point where I can do everything I wanted to do, and I'm still seeing signs of improvement," he shares some eight months after surgery.

According to Dr. Kurpad, seven patients so far across the country now have participated in this particular clinical trial – and all have shown progress three to four months post-surgery. "For a person like me, who has a high-intensity surgical job, if your clinical work goes well, it makes you feel good on your drive home from the hospital. But when your research goes well, it makes you feel good from one Christmas to the next," he says.

Dr. Kurpad is quick to point out that at any given time, MCW is undertaking two to three neurochemical clinical trials (which will have an effect on the functioning of the nervous system). "We have a very good reputation nationally, and many companies come to us before going to other institutions. That's because we have the referral base of patients, and our processes are very rigorous." He also cites the strong interaction among clinical and surgical staff, research labs, nurses and more. "At least seven different departments are involved before a stem cell is injected. This is a true representation of what Froedtert & the Medical College of Wisconsin is all about. We're like a well-oiled machine, and I am especially proud that so many disparate teams can come together to benefit our patients,” he says.

Lucas Lindner using his cell phone after surgery

Lucas Lindner selecting an app on his cell phone

Read more about clinical trials at MCW

From Bench to Bedside

In 2001, Dr. Kurpad received the prestigious William P. Van Wagenen Fellowship from the American Association of Neurological Surgeons, which provides support to a post-neurosurgical resident for foreign travel for scientific enrichment prior to beginning a career in neurological surgery. This award allowed him to become a guest scientist in the department of neuroscience at the Karolinska Institute in Stockholm, Sweden, where he studied under Lars Olson, PhD, a noted professor of neurobiology, from August 2001 to June 2002. There, Dr. Kurpad learned about a promising novel approach to treat spinal cord injury through the use of stem cells. He returned to the US as assistant professor of neurosurgery at MCW, where he was asked to establish a stem cell research lab that would be supported by extramural funding. The lab received its first grant in 2006 and has been funded extramurally for the past decade.

In the early years of his research, Dr. Kurpad's lab showed that it was important to genetically modify stem cells prior to transplantation in spinal cord injury, to both confer the desired neurological recovery as well as prevent potential serious side effects. This concept was ultimately shown by others to work in human stem cells, particularly the cell line used in the clinical trial. In early experiments, stem cells were cultured, propagated and chemically treated, then injected into rats with spinal cord injury to compare with a control group of healthy rats. The team performed tissue studies of the spinal cords of the rats, looking for markers that would demonstrate desired changes in the nerve cells.

This process alone required more than two years of preliminary study, as substantive data was needed to demonstrate that the engineered cells were capable of making myelin (the fatty sheath around nerve cells essential for conducting electrical signals) and stimulating growth. According to Dr. Kurpad, restoring as little as five to 10 percent of nerve function in the spinal cord can allow useful nerve impulses from the brain to propagate through the spinal cord and result in useful motor and sensory function.

Dr. Shekar Kurpad in his lab

Faculty partner in Dr. Shekar Kurpad's lab

Dr. Kurpad's research was published over the years in numerous prestigious journals and reported at national and international conferences. A similar concept in human cells was researched by California-based Asterias Biotherapeutics. The company wanted to conduct clinical trials by developing a line of engineered human stem cells in a similar fashion to the laboratory work to treat acute spinal cord injury. The timing of Lindner's auto accident in spring 2016 coincided with the launch of Asterias's novel clinical trial, which is being undertaken at a small number of hospitals around the country. Lindner, as one of Dr. Kurpad's first participants in the trial, underwent a procedure in which more than 10 million stem cells were injected into his spinal cord at the site of the injury. He was the first national recipient of this dose of cells (two of the first three such procedures were done at MCW).

– Maureen Remmel • Sara L. Wilkins

MCW Magazine: Clinical story MCW Magazine: Discovery story

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