IND Submitted for ImmCelz Regenerative Stroke Immunotherapy

Thomas Ichim, PhD

Creative Medical Technology has filed an investigational new drug (IND) application to the FDA requesting clearance to initiate the first clinical trial using its ImmCelz cellular immunotherapy for treatment of stroke, according to a recent announcement.¹

Patients in the proposed study will receive 1 injection of ImmCelz product at 0.5x10(6) cells per kilogram, increasing to 1x10(6) cells per kilogram in the second arm, and 2x10(6) cells per kilogram in the third. Each treatment group will include 8 patients, with a fourth group serving as a control. Both efficacy and safety measures will be observed across the 6-month study period.

"The uniqueness of the ImmCelz approach is that the immunological cells used are derived from the same patient to which they are administered.” Amit Patel, MD, board member, Creative Medical Technology, and co-inventor of the technology, said in a statement. “We have previously reported potent reduction of stroke infarct volume, as well as post-stroke behavioral improvements in animals treated with ImmCelz. We are enthusiastic to move this treatment into patients, with stroke being the first indication.”

The mechanism of ImmCelz is unique, utilizing stem cells outside of the body to “reprogram” the patient’s own immune cells to endow upon the immune cells’ regenerative activities, whereas other stem cell-based approaches use significantly smaller immune cells aimed at penetrating areas of the damaged brain and induce regeneration.

READ MORE: Mechanical Thrombectomy Fails to Show Noninferiority to Combined Intravenous Thrombolysis Approach

In December 2020, the company released positive preclinical data supporting the utilization of the immunotherapy. Administration of ImmCelz in an animal model of ischemia stroke resulted in a 34% reduction in infarct volume in the middle cerebral artery ligation model, compared to reductions of 21% by control bone marrow mesenchymal stem cells.²

At 28 days after induction of stroke, the animals who received ImmCelz had superior running time (92% of non-stroke controls) compared to animals which received bone marrow mesenchymal stem cells (73% of non-stroke control). Notably, running time that was 50% of non-stroke controls was observed in animals that received saline.

Using the Rotarod test, which evaluated motor skill learning, researchers noted improvements in functional recovery as well.

"This data, which is covered by our previous filed patents, such as no. 15/987739, Generation of autologous immune modulatory cells for treatment of neurological conditions, demonstrate that immune modulation via this stem cell-based method may be a novel and superior way of addressing the $30 billion dollar market for stroke therapeutics,” Thomas Ichim, PhD, coinventor of the patent and chief scientific cfficer of the company, said in a statement in combination with the release of the data.

The company announced additional data following that week, reporting that animals previously treated with ImmCelz showed an increase in “endogenous neurogenesis,” or the process that allows areas of the brain to health themselves more effectively after injury.³

Researchers found an 85% higher stimulation of endogenous neurogenesis in the ImmCelz group than those who received mesenchymal stem cells. Notably, the depletion of T regulatory cells in animal models resulted in suppression of endogenous neurogenesis.

The company noted they believe their treatment option may be more beneficial than other stem cells because of their ability to replication and form “memory” cells, substantially smaller size, and adeptness at surviving in conditions such as hypoxia or acidosis, which would inactivate stem cells.

"Based on our previous experiences with the FDA, we anticipate a smooth review process given the fact that the active ingredient in ImmCelz are cells from the same patient. Subsequent to the first IND clearance, we plan to file IND's on other indications, which appear promising based on preclinical data,” Timothy Warbington, president and chief executive officer, Creative Medical Technology, said in a statement.¹

REFERENCES

1. Creative Medical Technology Holdings files investigational new drug application (IND) with FDA for treatment of stroke using ImmCelz regenerative immunotherapy. News release. Creative Medical Technology Holdings. January 12, 2021. Accessed January 26, 2021. https://www.prnewswire.com/news-releases/creative-medical-technology-holdings-files-investigational-new-drug-application-ind-with-fda-for-treatment-of-stroke-using-immcelz-regenerative-immunotherapy-301206267.html

2. Creative Medical Technology Holdings announces successful application of ImmCelz immunotherapy for treatment of stroke. News release. December 16, 2021. Accessed January 26, 2021. https://www.prnewswire.com/news-releases/creative-medical-technology-holdings-announces-successful-application-of-immcelz-immunotherapy-for-treatment-of-stroke-301193921.html

3. Creative Medical Technology Holdings identifies mechanism of action of ImmCelz stroke regenerative activity. News release. December 22, 2020. Accessed January 26, 2021. https://www.prnewswire.com/news-releases/creative-medical-technology-holdings-identifies-mechanism-of-action-of-immcelz-stroke-regenerative-activity-301197267.html