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Unlimited Supply of Beta Cells Found

Posted: Wednesday, October 25, 2006

Diabetes in Control interviewed Novocells’ Chief Scientific Officer, Emmanual Baetge and he told us that they have determined the necessary conditions for turning human embryonic stem cells into insulin-producing cells, a finding that moves the prospect of using these cells to treat diabetes closer to the clinic.

Some work remains to be done before the cells are ready for patients, but the company anticipates phase 1/2 trials could begin as early as 2009.

'Our plan is to submit an IND towards the end of 2008 and get approval for phase 1/2 trials in the beginning of 2009,' said Emmanuel Baetge, senior author of the study, which Nature Biotechnology published online Thursday.

Baetge told Diabetes in Control, the company has already met with the Food and Drug Administration about its human embryonic stem cell line, which was isolated under good manufacturing practices.

The company plans to conduct additional animal studies the rest of this year and into next year. This would put it on track to perform scale-up in 2007 and conduct safety and efficacy studies in 2008, Baetge said.

In the study, the researchers developed a process for differentiating human embryonic stem cells into insulin-producing pancreatic endocrine cells. The technique, which mimics the normal development that occurs in the body, could be used for generating insulin-producing cells that could be transplanted into type 1 diabetes patients.

Baetge said it`s important to note that although the cells they generated produced insulin at nearly the levels found in adult pancreatic islet cells, they do not produce the hormone efficiently in response to glucose, or blood sugar, a critical requirement if they are to have clinical utility.

However, the cells appear to be at an earlier developmental stage, so the solution to getting them to respond to glucose may just be more development time.

'That`s exactly what you find in normal human development,' Baetge said. 'Only after birth do the beta cells begin consistently responding to glucose.'

The first step toward generating the insulin-producing cells requires engineering hESCs into definitive endoderm, the gatekeeper cells necessary for formation of the endoderm lineage, including liver, thyroid, parathyroid, lungs, stomach, intestine and pancreas. From the definitive endoderm, the cells are sequentially matured into foregut endoderm, pancreatic endoderm and endocrine precursors to become pancreatic endocrine cells. The insulin-producing cells contain high levels of insulin similar to levels found in adult human islets. Sugar induced secretion of insulin in the hESC-derived endocrine cells is low, similar to that seen in early human islets. However, these cells are capable of secreting insulin in response to numerous agents, indicating that they have many of the important characteristics of functional beta cells.

This is a Major Achievement, Robert Lanza, vice president of research and scientific development at Advanced Cell Technology, stated. 'It`s very impressive,' Lanza said. But he noted that Novocell will have to make a few tweaks before the cells are ready for the clinic.

A potential problem is immune rejection if cells from one person are placed into another. But, Novocell already may have found a way around that issue. The company`s cell encapsulation technology, which is designed to protect the cells from the body`s immune system, is currently in clinical trials and the results have been very positive. 'We already have two patients implanted and they`re completely off immunosuppression drugs,' Baetge said. The patients have encapsulated human primary islet allografts implanted under their skin.

'So far there are no severe adverse events,' he said, adding that the company plans to continue monitoring the patients without immunosuppressive drug administration, until loss of graft function.

Source: Diabetes In Control

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