Man-made tracheas move into clinical trial manufacturing phase

22-Jan-2014 - Last updated on 22-Jan-2014 at 07:44 GMT

Synthetically engineered tracheas may be marketed sooner than previously thought as a Harvard Bioscience spinoff prepares to produce the “scaffolds” for growing tracheas in more clinical trials.

David Green, CEO of Boston-based HART (Harvard Apparatus Regenerative Technology) told BioPharma-Reporter.com the public company is making the bioreactors and plastic-based “scaffolds” used to create the artificial tracheas in preparation for clinical trials in the EU after the company received a $5m (Eur3.6m) grant.

HART also recently helped surgeons in Russia perform three of the personalized surgeries with custom bioreactors and scaffolding for three patients, all of whom are still alive, Green said. The company will hold its first formal meeting with the US FDA in late January, and Green cautioned that “from a regulatory point of view” in the US, “there are no approved combo products” like this one.

“The regulatory pathway in the EU and Japan are less burdensome than the pathway in the US,” he said.

Electro-Spinning

In terms of the manufacturing process, Green explained, “We use a process called electro-spinning, which is unlike weaving…[as] weaving creates microns that are about the size of a human hair…we need 1 micron fibers so the [patient’s stem] cells can stick to them.”

“We dissolve the polymer, put it in a syringe, mount the syringe and push 10,000 volts through it in the shape of a trachea, which rotates as the volts pull the liquid out and the solvent evaporates and becomes a fiber,” he said.

“The fiber is then wound up like cotton candy. What this does is that it creates a porous scaffold – it’s 90% air and the fibers give it enough structure so the cells don’t fall through,” he added.

Bone marrow cells from a patient are then “pipetted onto the top of the scaffold in the spinning bioreactor,” which he described as the size of a shoe box. “It’s a little different from cell-based bioreactors because we’re keeping the cells at body temperature and sterile and feeding them with media while they penetrate the scaffold and the cells grow.”

In terms of the number of patients that this surgery could help, he said there are about 6,000 potential tracheal candidates worldwide, and although the surgery will cost more than $100,000, Green sounded confident that there will be more surgeries to come.

Moving Forward

HART in November went public and began with $15M in cash, Green noted, adding that the company is not raising capital yet “but we do expect to raise capital at some point.”

Green said that the technology and scaffolding could be used to create synthetic hearts, lungs, and esophagi in the future.

“The more complex ones are some years out before first in man trials but the esophagus is probably the closest as it’s a fairly simple organ…It’s several years away but it’s one of the first,” he said.

HART has collaborated with Dr. Harald Ott of Massachusetts General Hospital to develop its lung bioreactor system, as well as with Dr. Robert Simari of the Mayo Clinic to develop its heart valve bioreactor.