A technology called Icellator X — intended to generate a greater number of stem cells than achieved with prior methods — has been used in its first group of patients, which included people with fibromyalgia, its developer said.
The patients were treated at the Okyanos Center for Regenerative Medicine, in Freeport, Bahamas. Parkinson’s, rheumatoid arthritis, and osteoarthritis were among the disorders treated with the new approach.
Icellator X is an automated system that isolates adult stem cells from a small amount of the patient’s own adipose (fat) tissue, through a procedure called liposuction. According to Tissue Genesis, the company developing this enzyme-derived technology, Icellator X generated more than 100 million cells from each patient who received the therapy, which represents a higher yield than prior methods. As such, the device holds the potential to produce more reliable and reproducible results for people with each of these diseases.
Stem cell treatments have specifically been described as a potential therapy for the treatment of musculoskeletal pain, a hallmark of fibromyalgia.
“Launching this next generation device marks a major milestone for our company,” Ben Chlebina, Tissue Genesis’ general manager, said in a press release.
“We are now focusing on expanding the Icellator X into our clinical programs across the United States, as well as launching of our clinical and commercial efforts globally,” Chlebina added.
The system includes a single-use disposable kit to ensure sterility. The extraction process lasts approximately one hour, and generates a so-called stromal vascular fraction product that is sufficiently pure to allow for intravenous infusion, the company says.
“The Tissue Genesis team designed the Icellator X to become the gold standard in automated stem cell isolation,” said Rolf Wolters, the company’s director of product management. “We incorporated advanced hardware and software technologies to significantly boost Icellator X’s performance over our first-generation, industry-leading Icellator model.”
Icellator X has a user-friendly touchscreen interface available in multiple languages. It is ready for application in operating rooms, clinics and research laboratories, according to Tissue Genesis, and has been manufactured according to Good Manufacturing Practice standards set by the U.S. Food and Drug Administration.
More patients are scheduled to be treated at the Okyanos clinic in the coming weeks, according to the company.
“Our clinical team at Okyanos found the Icellator X to be simple to use and highly efficient,” said Vincent Burton, MD, president, chief medical officer, and chief anesthesiologist at the clinic. “The high yield of target cells is extraordinary and will ultimately deliver better outcomes for our patients … with neurologic, orthopedic and autoimmune conditions.”