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Early Trial Tests Stem Cell Immunotherapy for Liver Cancer

Human liver

(NLM.NIH.gov)

An early stage clinical trial by California Stem Cell Inc. in Irvine tested a therapy harnessing the body’s immune system to treat a common form of liver cancer. The trial, conducted with eight patients in Shanghai, China, showed the treatments were safe for patients with hepatocellular carcinoma and did not cause complications, according to the company.

Hepatocellular carcinoma is the most common form of liver cancer, and more prevalent in Asia and Africa than the U.S. The disease often is a result of cirrhosis or scarring of the liver, which itself can be caused by conditions such as alcohol abuse or hepatitis B or C. California Stem Cell’s medical director Michael Bayer notes in a company statement that China has “the largest incidence rates for liver cancer in the world,” with many liver cancer patients also suffering from hepatitis B.

California Stem Cell’s technology captures cancer stem cells from a patient’s own tumors. Cancer stem cells make up a small part of the tumor mass, but are among the most aggressive cancer cells in the tumor. The company’s approach is based on harnessing the these aggressive stem cells in a tumor to generate an immune response strong enough to counter their malignant impact.

The treatments using this approach are designed to treat the individual patient’s tumors. Cancer stem cells extracted from the liver tumors are made inactive, then enriched and combined with immune system cells called dendritic cells derived from the patient’s blood. This combination of tumor and dendritic cells is then reintroduced to the patient in a series of injections, with the aim of training the body’s immune system to target and eliminate the malignant cells.

A key objective of the trial, says the company, was to uncover any complications from the treatments, particularly when the patient also suffers from hepatitis B. “Initially there was some concern that these patients might experience flare-up of their hepatitis as the immune system was strengthened and directed to kill their cancer stem cells,” says Bayer. “However, those concerns proved to be unwarranted.”

The study also offered a way to test California Stem Call’s ability to generate the individualized treatments under its control, but in a remote location. The company says it produced the treatments in China under current Good Manufacturing Practices (cGMPs), a set of pharmaceutical production standards enforced by the U.S. Food and Drug Administration.

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