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Israel-based Orgenesis ( OTCBB : ORGS ) hopes to begin human clinical testing in 2014 of a novel technology to reprogram diabetics' liver cells into insulin-producing cells.

"Our objective is to release insulin-dependent diabetes patients from constant monitoring of glucose levels and insulin injections," CEO Jacob BenArie says in an interview with BioTuesdays. "By enabling a patient's own cells to produce insulin on demand, we have the potential to end diabetes as we know it."

To date, the company has safely and successfully reprogramed human liver cells from more than 70 donors to produce insulin and regulate glucose levels, according to Prof. Sarah Ferber, Orgenesis' chief scientific officer and the inventor of the company's autologous insulin-producing (AIP) cells.

"We have also done preclinical studies on diabetic mice, which were followed up for more than six months, demonstrating adequate insulin production," she says.

Orgenesis plans to submit its proof-of-concept and preclinical studies to the FDA and European Medicines Agency for approval to begin human clinical testing in the U.S. and Europe. "We hope to have an answer on a regulatory strategy in 2013 and begin clinical studies during 2014," Mr. BenArie says, adding that clinical sites in Asia and Asia Pacific may also be used.

In addition, the company is looking for contract manufacturers with GMP facilities to outsource its manufacturing. "There are markets where we can start selling the treatment during the clinical studies, but we are not there yet," Mr. BenArie says. "And we are looking for the big [pharma] players to help us push this product to market. I can tell you they are looking at us."

Prof. Ferber recalls that her 12-year odyssey was inspired by research that demonstrated the conversion of cytoplasts into muscle cells, because she was looking for options to generate insulin-producing cells. She says it was known at the time that there are transcription factors that control organ genesis in embryos. And in the 1990s, there was a paper that identified the transcription factors that guide organ genesis of the pancreas, which is responsible for insulin production. "So, I came to the idea that the same transcription factors that control organ genesis in embryos could change the developmental state of another organ as well."

That research, she says, eventually led to converting liver cells into insulin-producing cells.

Mr. BenArie says that pancreas islet-cell transplantation, developed in the late 1990s by researchers at the University of Alberta and known as the Edmonton Protocol, is currently the best cell replacement technology for insulin-dependent diabetics. "However, it is impractical because of a shortage of donor tissue and possible rejection by the patient's immune system," he adds.

"Orgenesis technology has all the advantages of pancreas islet-cell transplantation and more," Mr. BenArie contends. Since patients donate their own liver cells for treatment, it overcomes the shortage of tissue donations and avoids the need for highly toxic immunosuppressant drugs. Besides continuous control of blood glucose levels to avoid diabetes-related complications, it is a one-time treatment that becomes effective within a few days following the transplant, according to Mr. BenArie.

Prof. Ferber suggests that children with juvenile diabetes may have to have the procedure repeated later in life.

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Orgenesis' technology converts a patient's liver own liver cells into Autologous Insulin Producing cells

The procedure begins with a standard liver biopsy at an out-patient clinic. The biopsy goes to Orgenesis' core lab, where part of the biopsy is stored in a bio-bank and part for producing AIP cells in a process that takes five-to-seven weeks. The AIP cells solution, packaged in an infusion bag, goes back to the clinic, where a patient receives an IV transfusion in the portal vein of the liver, a process which is essentially the same as the Edmonton Protocol. The patient goes home the same day and, according to Mr. BenArie, should see the effect of the AIP cells within a few days.

"We are using the surgical portion of the Edmonton Protocol, so there is no new technology to implant AIP cells into the patient," he contends. "What is novel is reprograming liver cells. Sarah proved this in her research. The core technology is well proven."

Orgenesis has patents entitled "Methods of Inducing Regulated Pancreatic Hormone Production in Non-Pancreatic Islet Tissues" and "Methods of Inducing Regulated Pancreatic Hormone Production." These patents were written and are managed by law firm Mintz Levin of New York. The firm also purchased more than 2% of Orgenesis' shares, Mr. BenArie says, "so they strongly believe in our technology."

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.