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Cellular Dynamics Gets Into Regenerative Medicine With Eye Cell Deal

Xconomy Wisconsin — 

Cellular Dynamics International, the Madison, WI-based provider of human cells, took its first big step into regenerative medicine today with the announcement of a $1.2 million contract from the National Eye Institute. Under the agreement, Cellular Dynamics (NASDAQ: ICEL) will make stem cells and retinal cells that federal researchers will use to develop treatments for a type of macular degeneration, a common cause of blindness.

The move marks a significant milestone for Cellular Dynamics, which can manufacture huge batches of a variety of human cells from so-called induced pluripotent stem cells. Co-founded in 2004 by University of Wisconsin-Madison professor and stem cell pioneer James Thomson, Cellular Dynamics—aka CDI—went public last year and has so far focused its business largely on making cells for testing the toxicity of drugs and other compounds, as well as helping create biobanks of stem cells derived from donor tissue samples.

For a while, the company stayed conservative with its timeline for getting into cell therapies—meaning transplanting living cells into humans to treat diseases or regrow missing parts. Then, earlier this year, CEO Bob Palay started saying publicly that CDI’s first joint deal with a partner to co-develop a cellular therapy would come within a couple of years. The contract with the National Eye Institute, a division of the National Institutes of Health, marks CDI’s first such deal.

If the NEI research makes it to human testing, CDI believes it would be the first U.S. Phase 1 clinical trial using patients’ own cells that have been coaxed into an embryonic-like state and then into a specific tissue type (in this case, retinal tissue). And if those trials lead to an approved product—which, of course, will likely take years and lots more money—it would mark the first cell transplant treatment for dry age-related macular degeneration (AMD), CDI says.

AMD is a leading cause of blindness in people 60 and older, and as many as 11 million Americans suffer from some form of macular degeneration, the BrightFocus Foundation says. There are two types of AMD, wet and dry. CDI says there are no FDA-approved treatments for dry AMD, the more common but less severe kind. Meanwhile, wet AMD treatments—which generated more than $5.75 billion in revenue last year—require multiple eye injections that only slow the disease, but don’t cure it, CDI says.

“AMD is a debilitating disease,” Palay said in a press release. “It begins with vision loss in the center of the visual field and often progresses to nearly total vision loss.”

Taking skin and blood samples from AMD patients, CDI says it will make human retinal pigment epithelial cells that NEI researchers will use in studies that are intended to result in clinical-grade retinal tissue that would be transplanted into AMD patients. The cells would be a genetic match to the individual patient, thereby lowering the risk of the patient’s body rejecting the transplant, CDI says.

“We are excited to enable these researchers’ efforts to help patients regain their vision,” Palay said.

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  • levin zhang

    Is it safe enough to try iPSC in clinical trials?

    • Hi Levin, thanks for reading and for your question. At this point, human cells derived from iPS cells have not been taken to the point of a clinical trial in the U.S., so one can’t say with certainty that they’re safe enough to try in humans. That’s what this pre-clinical study with NEI will partly determine. But from CDI’s standpoint, they sound confident that the cells will be safe enough, primarily because they intend to implant therapeutic cells into each patient that are derived from the patient’s own cells. That makes it more likely that the body will accept the cells.

      • levin zhang

        Hi, Jeff, thanks for your explanation. i got it. it seems we have to wait and see what CDI will do.

  • Leslie

    Will the patients in the clinical trial have early or late stage dry macular degeneration? Will the transplant be in only one eye?

    • Hi Leslie, thanks for your question. CDI hasn’t specified which stage of the disease their cells will be trying to treat, nor if the transplant will be in one or both eyes. It’s important to note that this $1.2 million contract is only for pre-clinical studies, so the cells won’t be implanted in humans until the research moves to the point of a clinical trial. I think we’ll get a clearer picture of the plan if it reaches that point.