BioWorld International Correspondent

LONDON - NovaThera Ltd. has produced lung cells from embryonic stem cells, bringing to three the number of different types of cells it has succeeded in generating, and paving the way for the development of large-scale, standardized GMP manufacturing processes.

Gareth Roberts, CEO, told BioWorld International: "We have reached the point of having a basic process for differentiating embryonic stem cells into other cell types. We can now reliably produce heart, blood and lung cells using variations on this core process. The basic process is the same each time, but you run a different program, making things simpler from a manufacturing point of view."

Noavthera's scientific founder, Julia Polak, of the Tissue Engineering and Regenerative Medicine Center at Imperial College London, has persuaded embryonic stem cells to differentiate into Type II pneumocytes. Roberts said they are "fully analogous" to the naturally occurring cells that line the alveoli in the lungs, and claimed that it is the first time anyone has succeeded in generating them from embryonic stem cells.

While Roberts acknowledged NovaThera is still some way from producing cells that could be used as a directly administered cell therapy in lung repair, the company has a collaboration with Novalung GmbH, of Hechingen, Germany, to assess the potential of using the Type II pneumocytes in artificial lungs. Novalung manufactures a device, Interventional Lung Assist, that takes over oxygen/carbon dioxide gas exchange, giving the lungs of patients with acute respiratory failure time to recover, or to bridge the waiting time for patients who need a lung transplant. The portable device is connected to the blood flow without an operation and carries out gas exchange via a heparin-coated biocompatible membrane.

"This a good and useful machine, but the idea is to push the technology further and make the thing more efficient by using the human cells that are involved in oxygen absorption and [carbon dioxide] removal in the lungs," Roberts said. "The question is: Can we get the cells to live in their machines? It looks good so far, but it is early days."

If the cells can be used, it is hoped that it might be possible to reduce the dimensions of the device, which is 14 cm by 14 cm, down to a size where it would be possible to implant it.

As there would be no immune rejection issues, Roberts said using cells derived from embryonic stem cells in medical devices might be one of the first areas in which stem cells are commercialized for use in therapy. NovaThera is in the process of setting up a similar collaboration to use its cardiac cells in a device.

"We still believe in the longer-term prospect of cell-replacement therapy. But we are trying to advance in small steps, rather than having a grand vision that comes completely unstuck," he said.

The next stage is to develop large-scale, automated and standardized manufacturing processes. "Now we have the recipe, we want to feed it into large-scale production," Roberts said. In January, Cambridge, UK-based NovaThera was awarded a £3.75 million (US$6.9 million) government grant to identify the factors that control the reproduction and differentiation of stem cells and their interaction with biomaterials and scaffolds. The aim is to develop intelligent bioprocesses capable of generating appropriately differentiated cells, reproducibly and automatically.

"This is the key step in commercialization. We know the cells we have produced will be useful, the issue now is how to get enough cells," Roberts said.

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