New Documentary: ‘The Human Trial’ is a Quest to Cure Type 1 Diabetes


 2022-05-25

Learn more about The Human Trial and how you can support faster cures here.


 

Lisa Hepner has lived with type one diabetes for over 30 years. During that time, she heard time and again that a cure for diabetes was just five years away. That five-year mark has come and gone many times.

Eventually, the filmmaker, whose documentary The Human Trial premieres in select theaters starting June 24, stopped expecting a cure. That is until she went behind the scenes of a biotech company and learned what it takes to get a new treatment or cure to the general public.

Documenting the pursuit of a cure

Hepner and her filmmaker husband Guy Mossman decided to document the research of one company, ViaCyte, and the product they had developed, stem-cell-derived cell therapy to cure insulin-dependent diabetes.

But, as the film lays out, cure research has a lot going against it—steep costs, limited sources of funding, FDA regulation and a lengthy clinical trials process. All the while, the stakes are rising for trial participants and anyone waiting for a cure to diabetes.

Anyone with type 1 diabetes – and some people with type 2 diabetes – rely on life-sustaining insulin therapy. Diabetes is a major cause of blindness, kidney failure, heart attack and stroke. As of 2019, diabetes (all types) was the 9th leading cause of death worldwide, and nearly half of diabetes-related deaths happened before age 70.

“We only get to see this disease when the complications are so dire we need a cane because we can’t see or we lose a limb. I think that the invisibility of this disease has just made it that much harder to be taken seriously,” Hepner says.

What is regenerative medicine?

ViaCyte is a biotech research company focused on treating diabetes with regenerative medicine, which uses stem cells to engineer specific cell therapies. Stem cells are human cells that can develop into any type of cell. In ViaCyte’s case, researchers have programmed stem cells to act like beta cells in the pancreas.

Stem cells can come from many different sources. ViaCyte’s developed its cell line from an embryonic cell collected in the course of fertility treatment and later donated to research. Other stem-cell-derived therapies may retrieve stem cells from the patient themselves, or manufacture them in a lab.

The treatment ViaCyte is testing involves implanting their specially developed cells—which mimic islet cells, a pancreatic cell that is responsible for insulin production. Over time, the hope is that they will mature into fully functioning beta cells and produce insulin.

To protect the cells from being rejected by a patient’s immune system, the cells are placed in a pod-like device the size of a credit card, which is implanted in the body. Currently, patients must also take immunosuppressant drugs to further protect the cells.

“I think the science is more complicated than people think. Islet cells are very, very smart cells that do a lot. They don’t just produce insulin. So to create a thinking cell is a lot of work,” Hepner explains. “That may not show promise in the first round. But isn’t that what science is about? Failure in science is not failure in the general public. Failure in science is data to move forward.”

“But we don’t look at it that way because we’re patients and we’re frustrated and we’re mad and we’re broke, and we’re getting sicker,” Hepner reflects.

The trial

Over the course of a few months, the film captures the toll type 1 diabetes has taken on two trial participants, Maren Badger and Greg Romero.

Greg is experiencing changes in his vision, including bleeding in one eye due to retinopathy.

“Greg has these complications because he couldn’t afford proper medical care when he was younger and he didn’t have parental or family support,” Hepner says. “So through absolutely no fault of his own, he’s now dealing with the ravages of diabetes.”

Maren deals with severe low blood sugars, frequently at night. “She has two kids of her own and she adopted four kids,” Hepner says. “She has a lot at stake.”

Participating in a clinical trial is no small commitment. The documentary sees both Greg and Maren through numerous surgeries. They grapple with the physical burden of the many procedures and the emotional toll of not knowing the treatment’s effect. And, when the trial is over they will have to return to their normal diabetes management.

Funding cure research

The world of cure research is full of risks—research is time-consuming and incredibly costly.

A scientist could spend an entire career working toward a promising therapy and never see the results reach the public. Or, in the case of ViaCyte, develop a groundbreaking treatment that goes to the clinic without necessarily having the funding to keep it going.

It takes up to $2.8 billion dollars to get a new treatment from the lab to the general public. And as we see in the film, it’s hard to find investors who want to fund early research as there’s no guarantee of a return on investment.

“Embedding ourselves with this team of researchers at ViaCyte for seven years certainly opened my eyes to what it takes to get to a cure,” Hepner says. “I had no idea the demands of a clinical trial. I did not realize that on average, it costs $3 billion to take a drug from research to the marketplace—and that’s if it gets there.”

Changing the status quo of medical research

The COVID-19 pandemic had no small impact on the film’s production. It took over two years to edit the documentary remotely, Hepner says. However, watching vaccine and cure research efforts be pursued at record speed over the last two years—and successfully at that—brought important insight to The Human Trial.

Some facets of the research and clinical trial process are inherently lengthy, and many guardrails exist for safety and to protect the public—but some of them don’t have to take as long, Hepner emphasizes.

“So, that makes me excited and it makes me think you know what? Science takes time. Progress is incremental. But it’s happening. And I also think it’s happening at an exponential rate,” Hepner says.

Who should watch The Human Trial?

“We want people who like to watch documentaries on Netflix, who want to see a good film about a quest that humanizes science. We want people to watch this film who don’t know anything about diabetes, who are drawn to it for other reasons, and learn along the way that this disease is very serious,” Hepner says.

“Because diabetes should be taken seriously and it should be cured.”

Learn more about The Human Trial here.