Investigational Immunotherapy ImmCelz Shows Promise in Mice

Creative Medical Technology Holdings has extended the applications of its investigational “regenerative immunotherapy” ImmCelz to include Parkinson’s disease, after seeing positive preclinical data from a mouse model of the disease, according to a company press release.

ImmCelz inhibited the onset of Parkinson’s symptoms in a mouse model of the disease and helped protect dopamine-producing neurons — those responsible for releasing the neurotransmitter dopamine, a critical neurotransmitter that regulates brain cell activity and function – whose loss is a hallmark of Parkinson’s disease.

These effects were accompanied by an increase in brain levels of the anti-inflammatory molecule interleukin-10. In Parkinson’s, the progressive loss of dopamine-producing neurons in the substantia nigra — a brain region implicated in motor control — is associated with brain inflammation.

Researchers used the MPTP mouse model, an established tool and one of the most commonly used animal models in Parkinson’s disease research. To induce Parkinson’s-like symptoms, mice are injected with a compound called MPTP, which leads to neurotoxicity in the dopamine-producing neurons.

ImmCelz uses a patient’s own blood immune cells, which are cultured in the lab with donor stem cells along with interleukin-2. This reprograms patients’ own immune cells and increases their regenerative capacities. Because immune cells are significantly smaller than stem cells, they can enter the brain more easily and induce regeneration of damaged areas.

ImmCelz was developed initially for the treatment of stroke and the company has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration seeking approval to begin clinical trials.

ImmCelz has yielded promising results in additional preclinical models of liver failure, diabetes, and rheumatoid arthritis, according to the company, which now expects to expand the use of ImmCelz for neurological diseases.

“We are committed to advancing our lead indication for ImmCelz®, which is stroke, for which we are currently addressing comments provided by the FDA before we can initiate human trials,” said Timothy Warbington, president and CEO of Creative Medical Technology Holdings.

“Once human trials are cleared for stroke, we anticipate initiating trials in other indications for which we have seen preclinical efficacy, thus creating a significant product pipeline for this first in class approach we term Regenerative Immunology,” he added.

Supported by preclinical data, Creative — trading under ticker symbol CELZ —  has filed for a patent of its “regenerative immunotherapy” approach.