Research into possible functional cures for Type 1 diabetes is often open-ended, with no guarantee of success. The same can be said of documentary filmmaking, since the outcome of the story being told is often unknown when filming begins. A documentary in progress happens to combine the uncertainty of both endeavors in one project.
Lisa Hepner is a director of documentary films, and she has Type 1 diabetes. As she was recovering at the hospital in 2008 from a dangerous nighttime low, her business partner (and now husband) Guy Mossman said to her, “We should make a film about diabetes.”
By 2011, having moved from Brooklyn to Los Angeles, they began educating themselves about the medical research business, searching for a diabetes documentary project, and talking with medical researchers and people with diabetes who might be willing to come in front of their cameras. They found the opportunity in a stem cell implantation trial being organized in 2013 in San Diego.
“The public still knows very little about diabetes,” Hepner said in a telephone interview.
She and producer Angel Castillo believe that as treatment devices like pumps become smaller, and insulin pens make injections easier, it all makes daily maintenance more discrete, ultimately allowing a national public health problem such as diabetes to remain curtained in misunderstanding.
“That’s the great irony of it,” Castillo added.
Their non-profit company, Tenth Muse Films, hopes to raise the curtain in 2017 on The Human Trial, a film that will showcase the need for sustained philanthropic investment to bring about breakthrough technologies, in this case the implantation of pancreatic cells. Their first project is focused on ViaCyte, a San Diego biotech which is trying to use a novel approach to implant pancreatic progenitor cells into people with diabetes that will mature into functional beta cells. (The filmmakers have no affiliation nor financial connection with any of the companies or entities appearing in the film.)
ViaCyte is testing a product identified as a VC-01 combination device. It’s a mesh pouch encapsulated in a pliable membrane which allows hormones, metabolic fluids, and oxygen to migrate, but resists immune system T-cell invasion. T-cells in people with Type 1 often target implanted beta cells, making beta cell transplant a very frustrating treatment option.
The VC-01, dubbed the “teabag”, is designed to stop this destructive process. The pouch holds clusters of immature cells deigned to mature to produce insulin, glucagon, and hormones. It’s about the length and thickness of a credit card, but half the width. Surgeons at UC San Diego and the University of Alberta have begun implanting it in live test subjects. ViaCyte foresees six implantations of its VC-01 pouch in each patient to accomplish restoration of pancreatic function.
The cells ViaCyte uses originated with a single line of stem cells material harvested from an in vitro fertilization. Theoretically, this material, through laboratory regeneration, has the ability to supply hundreds of thousands of Type 1 patients with beta cells. If the cells mature once introduced to the body, there is the potential that this technology could benefit every person with Type 1 in the world. ViaCyte is careful to point out in its public communications and the film in progress that its cell material is not harvested from aborted fetal tissue.
ViaCyte characterizes its trial as a test of safety, tolerability, and ability of the cells to remain protected from the immune system. The FDA record of ViaCyte’s FDA submission also lists efficacy among its objectives.
ViaCyte’s FDA filing discloses a four-year time frame for implantation in a total of forty patients in the California and Alberta cohorts. In the U.S., it can take $5 billion to bankroll research and development of a drug or device, shepherd it through conventional, statistically measured, phased clinical trials, and only then take its chances at success on the U.S. market. When ViaCyte submitted its FDA filing in September 2014, only two other embryonic stem cell human trials had ever been given the green light in the U.S., and only five others in the world. FDA granted expedited review of the proposal, and cleared the human trial in 2014. Canada followed with its go-ahead in January of 2015. At the time we spoke with the filmmakers in late 2015, one American and two Canadian patients had undergone the implant surgery.
The film project, The Human Trial, doesn’t follow a screenplay with a happy ending. The filmmakers are working without any guarantee that their venture will break even. For Tenth Muse Films, it’s a pro bono mission, Castillo says, which is now entering its third year. Once the surgical trials commenced, the shooting schedule essentially went out the window.
“We‘re filming in real time, as progress is made. So we don’t know what the end point for filming is,” Lepner says. “There’s a tipping point out there, and we are someday going to have to decide that the film is ready for release.”
To see the trailer for the work in progress, go to The Human Trial.
Editor’s Note – This article has been edited to clarify that Tenth Muse Films is not financially or otherwise connected to the ViaCyte company. Also, an earlier version of this article incorrectly named Vox Pop Films as the non-profit funding the documentary; Vox Pop is actually one of several production companies working on this documentary.
Editor’s Note (3/1/2016) – We were contacted by Dr. Brandon after this story had been published, who asked for several clarifications. Chiefly, it was asked that a distinction be made between the cells being used. They are progenitor cells, not stem cells; the two types of cells are very similar, but progenitor cells are more further developed than stem cells. When there was a factual difference between what was said in the story and the edits asked for by Dr. Brandon, we have edited the story to incorporate Dr. Brandon’s changes.
Editor’s Note (3/10/2016) – All quotes or comments from Dr. Brandon have been removed.
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