There’s a cocktail of confidence craved by those who hope for a cure for type 1 diabetes (T1D): A perfect blend of hope, education, and proof in incremental steps.
Soon, that cocktail will be available to all at movie theaters around the country, as well as on streaming services.
“The Human Trial,” a documentary film in production for more than 8 years now, is expected to be released in early fall 2021.
The film follows a diabetes research project as it evolves through research and development, clinical trials, and more.
The bonus? ViaCyte, the company the filmmakers followed, is announcing breakthroughs just as the film readies to go live. ViaCyte has developed a method of programming human stem cells to differentiate and grow into new insulin-producing cells to implant in the body, housed in a tiny device — effectively, a functional cure for T1D.
“The Human Trial” found its roots in a powerful overnight hypoglycemic event (severe low blood sugar), something all people with T1D can relate to.
When Lisa Hepner lived in Brooklyn with her partner and fellow filmmaker Guy Mossman, she’d not really exposed him to the darker side of life with diabetes; not because she was protecting him, but more because after living with it for most of her life, she had become accustomed to just trying to just blend it into life.
But when she awoke one morning in those tussled, sweat-soaked sheets oft found post-hypo, he asked and she told.
And then it dawned on them: They had to make a documentary about this.
“I was hesitant,” she said of considering the project. “I didn’t want diabetes to become my life.”
They poked at the idea for a time and then decided on a plan: Rather than just focus on what it means to live with T1D, they would humanize the disease with personal stories tied to hope — hope in the form of pathways to a cure.
“We buckled down and did our research,” she said. “We really wanted someone doing something with islet cells, and we found ViaCyte.”
They first met with the ViaCyte team in 2013, she said.
“It took us a year to convince them that opening up the lab to a bunch of documentary makers was a good idea,” she said, pointing out that she was clear to the ViaCyte team from the start they were not there to make a “Rah-rah story,” but rather to dig into just how and why research for treating and curing T1D is so complicated.
ViaCyte’s Chief Medical Officer Howard Foyt and his team agreed, and right away, Hepner saw they were going to have success in filming.
“They gave us access to meetings I never thought they would,” she said. “Even when there were financial issues, we were there and they were open.”
“We were in the room when they got the FDA news that their new drug application was approved in 2014.” From there, she said, she and her documentary team had access to all the nooks and crannies found on this path to a potential cure for T1D.
As the years of filming went by, it became clear to all involved: they were the right team to make this film.
It helped from the start that Hepner lives with T1D and a strong personal desire to be cured. While documenting, she watched both as a filmmaker and a person with diabetes.
Her film experience is storied. She and Mossman run Vox Pop Films, an award-winning production company based in Los Angeles.
She has produced a variety of films and programs for Sony Pictures Classics, HBO, A&E, PBS, Lifetime, Discovery, MTV, TLC, and the CBC. She has also produced for acclaimed directors Jonathan Demme, Michael Apted, Julie Taymor, Lisa F. Jackson, and Bobbie Birleffi.
Her diabetes experience comes in real time: She’s had T1D for more than 25 years.
It helped, too, that Foyt and his team at ViaCyte were laser-focused on their goals. While the film crew started out following three diabetes projects, the other two (as shown in the film) dropped away in favor of focusing on the main, most promising project.
It also helped, Foyt said, that he was willing to take direction on how to talk about ViaCyte’s work.
“I’ve spoken many times, of course, to both researchers and diabetes support groups. People with diabetes [and their loved ones] tend to be more up to speed, and so I can speak as I usually would,” he said.
But realizing that the goal was to get not just the diabetes community but the world to understand and care about this research, Foyt knew he had to tone down the scientific jargon, and work at speaking in simple and clear terms.
“I sometimes had to do two or three takes on a given response,” he said.
Hepner said his patience with that was remarkable — and it pays off in the film.
At the same time, as events unfolded, Hepner was able to react and respond to them as a person with diabetes first — something that helped guide them to know how to follow the plot for viewers in general.
In other words: her directorial expertise was led by her natural reaction as a person with T1D.
To understand the key moments in the film, you must first understand exactly what San Diego-based ViaCyte is attempting to do and why it matters.
Hepner said she was drawn to the ViaCyte story for two main reasons: their work at creating a singular source of insulin producing islet cells for all, and the idea that they were not working on an external device (something many other companies were and are doing).
ViaCyte’s goal is to create an encapsulated supply of insulin-producing cells that can be placed in the body — implanted under the skin — to serve as an insulin supply long-term (a year or 2 at a time), replacing the need for injections, carb counting, or devices like an insulin pump.
They’ve succeeded in the cell source, said Foyt. In 2004, a couple who had finished building a family via in vitro fertilization (IVF) donated one of their embryos, called a blastocyst, to ViaCyte for the company to work toward their goal of producing a cell line.
“We have an inexhaustible supply of islet cells,” he said. “That’s the beauty of embryonic stem cells. We can now provide enough cells for every person with diabetes on the planet — all from that one 8-cell blastocyst, donated from a family who had completed their family.”
In other words, they’ll never need to use another blastocyst for that again.
ViaCyte has worked at creating the right “pouch” to hold the cells, a process that has taken some time and was followed closely in the film.
Some materials caused a response in the body similar to when you leave a splinter in your finger: The body fights the foreign object and grows protective scar tissue around it.
That action, Foyt said, would cut off oxygen and other nutrients to the cells inside. So, they began working on solutions.
At first, they also focused on a pouch that could be implanted without the need for any immunosuppressant drugs. But over time, when it was clear that would take some extra time, they also took up the goal of creating a pouch that does require some immunosuppressants.
They developed something called the PEC Direct, a pouch with tiny holes punched into it to allow the needed nutrients in, while immunosuppressants fight off any protective cells that may try to kill the new insulin-producing cells.
Foyt said the immunosuppressants are basically the same used in islet cell transplantation, as made popular via the groundbreaking “Edmonton Protocol” (that modified existing immunosuppression regimens to greatly increase therapeutic impact and overall success rate).
Foyt says the PEC Direct is a vast improvement, because of their cell line (which means they have plenty and the cells will always come from the same source). That means when and if the procedure needs to be reproduced, the person with diabetes will receive the exact same cells, a valuable choice since it means you can be confident they will survive in the person.
And good news came: In study results announced at the American Diabetes Association’s June 2021 virtual annual conference, they demonstrated the first scientific exhibition of patient data showing an increase in glucose-responsive C-peptide — proof that ViaCyte’s cells grew into insulin-producing cells and got to work from inside the pouch.
ViaCyte will continue to work on that, as well as on their goal of a system that requires no immunosuppressants.
All that isn’t something that happens in a flash. But the film boils it down to moments — both those of great hope and celebration and those of some disappointment.
Like the moment when a man who allows them to follow an endocrinology appointment learns he’s losing his eyesight.
“Its a universal moment of suffering that people will connect to,” Hepner said.
There are also disappointments and thrills within the lab.
What following that does for the viewer, Hepner said, is help them both learn and embrace the importance of finding a cure for T1D, and helping show just how medical processes work.
Hepner remembers one day that’s a big moment in the film: The day ViaCyte learned a patient was producing C-peptide.
“Howard [Foyt] came in and told me about the news,” she remembered, and I was a like, “Holy smokes, maybe this is IT!”
But Foyt immediately tempered her reaction.
“He stopped me right there and reminded me: we cannot get excited about one result,” she said.
“That was big for me, as both a filmmaker and a person with diabetes, “ she said. “You have to understand how science works.”
And so, the film takes moments of celebration, of frustration, of breakthroughs and planning and lays it out for the viewer, helping them learn and understand the pace of science, and to see, via some successes, what she feels is the most important plotline of all: “That if science is supported over time, it is effective.”
“After 10 to 15 years of clinical development, studies, and more, ViaCyte has proven efficacy in one patient,” Hepner said. “We are cautiously optimistic. We have hope, but with a feeling of responsibility,” she said.
Still, Foyt is thrilled with the news, and he also points out that since trial participants are using continuous glucose monitoring (CGM) now, they can track things like time in range, which he said grew from an average of 54 percent to an average of 88 percent in those in the trial. In addition, instances of hyperglycemia (high blood sugar over 250 mg/dL) dropped from an average or 13 percent to zero, and A1C results dropped from an average of 7.4 to 6.6 in the study.
Next up, they’re working to revise the membrane in the pouch in the hopes of improving its lifespan in the body, and hope to launch a second study in the coming year.
One thing is for sure with the release of “The Human Trial” film: their name and project will be known.
Hepner said they hope to premier the film with an in-person launch some time in the fall, but have no detailed announcement yet.
And while it all started with a sweaty, bothersome overnight low blood sugar, she’s excited that the film can help bring to the mainstream the value of clinical trials.
“This is obviously going to make a difference,” she said. She hopes the public understands the need to support clinical trials in all ways — financial and otherwise.
She also sees benefits for those with T1D who have been hanging onto hope for a cure — or sometimes losing their grip on it.
Rather than lamenting a failed promise of “a cure in 5 years,” she hopes people like her, hungry for breakthroughs for a long time now, see the film and understand that progress marches at its own pace. Never, she said, does it mean folks are giving up.
“I want to switch the conversation,” she said. “Hope sells. Diabetes will be cured. I just know it will be now.”