FDA Responds to Creative Medical Technology Holdings Regarding Its ImmCelz® IND for Stroke Treatment
Creative Medical Technology Holdings (CELZ) announced receipt of detailed correspondence from the FDA regarding IND #27375 for its ImmCelz® regenerative immunotherapy targeting stroke treatment. This innovative therapy employs a patient's own reprogrammed blood cells, demonstrating effectiveness in animal models for various conditions, including heart and kidney failure. The company's leadership expressed gratitude for the FDA's constructive feedback, essential for the IND proposal's progression. This marks a significant step in their journey towards obtaining regulatory approval for a pioneering treatment.
- Receipt of constructive feedback from the FDA on IND #27375.
- ImmCelz® has demonstrated efficacy in animal models for multiple severe conditions.
- None.
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
Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in regenerative medicine/stem cell technology in the fields of immunotherapy, urology, neurology and orthopedics and is listed on the OTC under the ticker symbol CELZ. For further information about the company, please visit www.creativemedicaltechnology.com.
Forward Looking Statements
OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at www.sec.gov.
Timothy Warbington, CEO
CEO@CreativeMedicalHealth.com
www.Creativemedicaltechnology.com
www.StemSpine.com
www.Caverstem.com
www.ImmCelz.com
www.OvaStem.com
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SOURCE Creative Medical Technology Holdings, Inc.
FAQ
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