FDA Responds to Creative Medical Technology Holdings Regarding Its ImmCelz® IND for Stroke Treatment
PHOENIX, May 14, 2021 /PRNewswire/ -- Creative Medical Technology Holdings Inc., trading under ticker symbol CELZ, announced today receipt of detailed correspondence from the FDA regarding necessary modifications to IND #27375 for using ImmCelz® regenerative immunotherapy for the treatment of stroke.
The Company's ImmCelz® product utilizes a patient's own blood cells that have been "reprogrammed" in the laboratory by culturing with established universal donor stem cells, followed by re-infusion into the patient. Efficacy in animal models has been demonstrated in heart failure, kidney failure, multiple sclerosis, liver failure and type 1 diabetes. Given that this is the first time such a product was brought to the FDA, the Company appreciates the detailed analysis provided by the Agency, and the constructive feedback.
"I am grateful for our scientific and clinical team which has assembled the ImmCelz® IND proposal for the FDA, which resulted in detailed comments and advice for moving forward. Our team is already working on it." said Timothy Warbington, President and CEO.
About Creative Medical Technology Holdings
Forward Looking Statements
Timothy Warbington, CEO
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SOURCE Creative Medical Technology Holdings, Inc.
Company Codes: OTC-QB:CELZ, OTC-PINK:CELZ