Since Fujifilm acquired Cellular Dynamics International for $307 million last year, CDI hasn’t made any major declarations regarding when—or how—it would use products manufactured by its parent company.
That changed on Wednesday, when CDI, the Madison, WI-based provider of human cells, said it had entered into a collaboration with the National Eye Institute (NEI), one of the National Institutes of Health.
Like CDI’s agreement with the NEI announced in 2014, the new partnership is aimed at making stem cells and retinal cells for use in the development of a therapy for retinal degenerative disease. However, the more recent deal also includes the goal of creating a “biocompatible, biodegradable scaffold,” CDI says in a press release. Researchers would be able to create and grow cell tissue on these scaffolds, CDI says, and they could potentially be made of Fujifilm-developed recombinant peptides.
CDI chief executive Kaz Hirao, who prior to the acquisition managed business development for Fujifilm’s pharmaceutical division, in November told Xconomy that Fujifilm intends to become the global leader in regenerative medicine. CDI, whose induced pluripotent stem cells (iPSCs) can be differentiated into any type of cell found in the human body, can help further that aim through the company’s collaborations with the NEI, he says.
“While iPSC-derived cells have great potential for regenerative medicine applications, there are many hurdles yet to overcome,” Hirao says in a prepared statement. “This agreement builds on the longstanding relationship between CDI and the National Eye Institute to address some of these hurdles, and may lead to iPSC-based therapies for patients with serious diseases of the eye.”
Under the terms of the deal, CDI and the NEI will develop up to five lines of iPSCs. These cells will be matched using the human leukocyte antigen (HLA) system, a gene complex encoding proteins responsible for the regulation of the immune system. CDI has said this process is key to stem cell transplants because the immune system considers cells without matching HLA to be foreign invaders, resulting in immune rejection.
CDI’s other partnership with the NEI is focused on developing treatments for age-related macular degeneration (AMD), a common cause of blindness in people 60 and older. As many as 11 million Americans suffer from some form of AMD, according to the BrightFocus Foundation. There are two kinds of AMD: wet and dry. CDI has said there are no FDA-approved treatments for dry AMD, the more common but less severe type. Wet AMD treatments, meanwhile, require multiple eye injections that can slow the spread of the disease but are not considered cures.
Taking blood from AMD patients, CDI says it will make human retinal pigment epithelial cells that NEI investigators will use in studies. Their objective is to develop clinical-grade retinal tissue that would be transplanted into AMD patients, CDI has said. The cell tissue would be a genetic match with the individual patient; this pairing reduces the likelihood of a patient’s body rejecting the transplant.
If the NEI research makes it to human testing, CDI has said it would be the first U.S. Phase 1 clinical trial using patients’ own cells that have been reprogrammed into a specific type of tissue (in this case, retinal). Ultimately, the goal would be the first cell transplant treatment for dry AMD.
However, since the $1.2 million contract the NEI awarded to CDI in 2014 only covers pre-clinical safety studies, getting there would likely require NEI researchers to file an investigational new drug application with the U.S. Food and Drug Administration. From there, a drugmaker would probably be needed to move the research through clinical trials.