A novel treatment meant to stop Type 1 diabetes by increasing the number of T cells in the body is being given special attention by the FDA. The treatment, called CLBS03, has recently been granted Fast Track status by federal regulators, a designation which speeds up the approval process.
The CLBS03 treatment clones T cells from the patient to combat Type 1 diabetes. This may at first seem counterintuitive, as T cell attack is what destroys insulin-producing beta cells in the first place. However, the T cells in this treatment (T regs) regulate T effector cells, which are the cells that attack the body in autoimmune diseases. Essentially, the T regs would manage malfunctioning T effectors and, in theory, stop beta cell destruction. T regs have been used to effectively treat other autoimmune conditions.
The treatment is being developed by Sanford Health, in collaboration with Caladrius Biosciences, Inc.
The Fast Track designation is meant to expedite treatments that address a serious condition or an unmet medical need. Drug applications that are on the Fast Track are eligible for special privileges, including more frequent communication between treatment developers and FDA officials to discuss development and clinical trials. Fast Track drugs can also be eligible for accelerated approval, which can shorten the FDA review process of a new drug from 10 months to just six. While Fast Track status does not guarantee a treatment will receive FDA approval, it does quicken the process to get to the endpoint of its development, for better or worse.
Previously, Phase I studies with the drug showed that treatment preserved pancreatic beta cell function and reduced insulin requirements. Currently, this drug is being tested in a Phase II trial that involves 111 teens with Type 1 who still have residual beta cell function. To learn more about enrollment for this trial, go to http://www.sanfordhealth.org/promo/the-sanford-project.
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