Last Update: July 3 @ 11:40 PM
Life Sciences
Lincoln company on cutting edge of cell implants
By Marion Davis
Contributing Writer
COURTESY INCYTU INC.
INCYTU PRESIDENT-CEO Alfred Vasconcellos, left, and chief scientific officer Dwaine Emerich work with a vial of the gel form of their product-in-development Cellarium.

The promise is enthralling: cures for cancer, for heart disease, for Parkinson’s and Alzheimer’s; new hope for paraplegics; ways to re-grow healthy, strong tissue and blood vessels after surgery and grievous injuries.

But in reality, cellular medicine has yet to quite realize its potential. Somewhere between the Petri dish and actual patients, countless “miracle cures” are unraveling – not quite working right, not quite making the expected impact.

The main reason, says Alfred Vasconcellos, president and CEO of InCytu Inc., a fledgling biotech firm based in Lincoln, is that when you inject cells into a body, they not only spread beyond the target area, but some 90 percent die off.

If you try implanting the cells on a matrix, on the other hand, the cells often cling to the matrix, failing to integrate themselves properly into the tissue.

Enter David Mooney, a bioengineering professor at Harvard University who found what he believes is the solution to this dilemma: a way to inject or implant cells in a concentrated, localized way, but in a medium that dissolves within a specific amount of time.

To commercialize Mooney’s discovery, Harvard teamed up with a group of scientists and entrepreneurs, led by Vasconcellos and Chief Scientific Officer Dwaine Emerich, best known in Rhode Island as co-founders of CytoTherapeutics, now part of California-based StemCell Inc.

In April 2007, the team incorporated InCytu, with Harvard as minority owner, set up shop in CytoTherapeutics’ former space in Lincoln, and began developing the Cellarium System – Mooney’s discovery transformed into injectable gels, patches and self-dissolving scaffolds.

As Vasconcellos describes it, the potential applications for Cellarium are as diverse and numerous as for cell-based medicine itself: “Anyplace where tissue is healing or that biological processes are going on, we can accelerate those and control those.”

In practice, that means diabetics with foot wounds that won’t heal and could require an amputation could not only heal those wounds, but restore proper blood flow to their heels.

The roughly 5 to 10 percent of hernia patients whose repair surgeries fail could have their muscles healed and regenerated properly.

Victims of gunshots and shrapnel wounds could have their injuries healed more quickly, with minimal scarring and good blood flow.

Heart-attack victims could have at least part of the damage to their heart muscle repaired, improving heart function and reducing the risk of future heart attacks.

And some day, spinal cord injuries, brain damage and currently unhealable bone fractures could be repaired.

Plus fast-acting, deadly cancers such as melanoma might be prevented by stimulating the growth of dendritic cells, which “tell” the lymph nodes how to build defense mechanisms.

“There’s a lot of us who believe that the future of medicine will lie in the transplantation of cells,” Vasconcellos said. And while others have devised the individual therapies, he said, what InCytu can contribute is a way to make those therapies work.

Not that InCytu, which at this point has only nine employees – plus a small stable of consultants – expects to make all those miracle cures a reality overnight, or on its own.

For starters, it’s had to develop and test Cellarium in the lab while raising money, a combined $1 million through the seed and angel stages, Vasconcellos said. Now the scientists are laying the groundwork for clinical trials while another $5 million to $7 million is raised through a Series A investment round. The Series B round, he said, should cover the first phases of the clinical trials, which are set to begin no later than 2010.

The results so far are dramatic, Vasconcellos said. In tests with lab rats, for example, the femoral artery was cut, and while the untreated animals lost the injured legs, the treated ones developed new blood vessels and were back to normal in six weeks.

A trial of a melanoma vaccine using tiny polymer implants to gather dendritic cells, program them to recognize cancer cells, and reproduce them rapidly, also showed great promise, Vasconcellos said, with 88 percent of the subjects surviving more than 250 days, while the control subjects all died within 23 days.

And Cellarium’s potential uses for muscle tissue regeneration have drawn the interest of the U.S. military. Earlier this year, InCytu was invited to be a partner in the newly formed Armed Forces Institute of Regenerative Medicine, which aims to develop better treatments for battlefield injuries using stem cells and growth factors, tissue and biomaterials engineering, and biorestorative transplants.

InCytu’s plan, Vasconcellos said, is to bring Cellarium to market for specific applications, one by one, most likely manufacturing it themselves and then selling it, at least at first, through large pharmaceutical and/or medical device companies.

With so many possible uses for Cellarium, it’s crucial to focus on the applications that can be brought to market quickly and are likely to be adopted quickly, Vasconcellos said – but that “at the same time, create a significant benefit to patients.”

By that standard, treating diabetics’ skin ulcers is the first priority. There are about 1.5 million patients in the United States alone who could benefit, Vasconcellos said; for them, Cellarium would be shipped as hydrogel bandages to be applied to the wounds.

The second planned application, Vasconcellos said, is accelerating muscle healing – in hernia repair, in surgical sites, and to repair penetrating muscle wounds (primarily in military applications, at least at first, he said).

And because cancer is such a high-priority field, the melanoma vaccine is the planned third application, Vasconcellos said – though that is not, by far, the end of the list.

While this is expensive work to be involved in, given all the pre-clinical testing that has to be done and the care and regulatory scrutiny involved in clinical work, Cellarium is not envisioned as one of those super-expensive medical products that few can afford.

Depending on the form in which Cellarium is used and what it’s applied to, Vasconcellos said, the price is likely to be in the hundreds or thousands of dollars, not tens of thousands or more.

“These will be very cost-effective therapies,” he said. •

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