Company reaches next clinical trial
milestone for treatment of Type 1 Diabetes with the first novel
allogenic cellular therapy in the dorsal artery of the pancreas in
the United States
PHOENIX, Feb. 8, 2023
/PRNewswire/ -- Creative Medical Technology Holdings,
Inc. (NASDAQ: CELZ), a biotechnology company working to
revolutionize care through the development of potentially
best-in-class regenerative therapeutics, today announced that it
has received Institutional Review Board (IRB) approval to proceed
with its Clinical Trial for the treatment of Type 1 Diabetes with
its CELZ-201 cell therapy. The U.S. Food and Drug Administration
(FDA) had previously cleared the Company's Investigational New Drug
(IND) application within 30 days from submission.
The Company believes that CELZ-201 leverages a unique approach
to harnessing the power of Perinatal Tissue Derived
Cells® (PRDC) to multi-potentialities, including
self-renewal ability, low antigenicity, reduced toxicity, and
large-scale clinical expansion. The primary objective of the study
is to evaluate CELZ-201 as a treatment for patients with newly
diagnosed Type 1 Diabetes.
The company sponsored trial will be conducted at the
University of Miami Health System in
conjunction with the Diabetes Research Institute.
"The purpose of IRB review and approval is to assure that
appropriate steps are taken to protect the rights and welfare of
patients participating as subjects in the research and is an
important milestone in proceeding with a clinical trial. We are
pleased with achieving IRB approval expeditiously and look forward
to moving forward with our Phase 1/2 clinical trial," Said Timothy Warbington, CEO of Creative Medical
Technology Holdings, Inc.
"I am excited to proceed with the CELZ-201 perinatal cell
product in this study, as I believe that if successful it could
result in a promising treatment for many patients with Type 1
Diabetes," said Dr. Camillo Ricordi,
Safety and Efficacy of CELZ-201 in Patients With Recent Onset
Type 1 Diabetes - Full Text View - ClinicalTrials.gov
About Type 1 Diabetes
As of 2019, there were 1.6
million adults aged 20 years or older diagnosed with Type 1
Diabetes (T1D) in the United
States. The economic burden caused by T1D amounts to
approximately $14.4 billion in
medical costs and lost income, and there are currently limited
treatment options beyond insulin. T1D results from the autoimmune
destruction of insulin-producing islet cells in the pancreas,
leading to loss of insulin production and impairment of blood
glucose control. The absence of insulin leads to abnormalities in
how the body processes nutrients, leading to high blood glucose
levels. High blood glucose can lead to diabetic ketoacidosis and
over time, to complications such as kidney disease/failure, eye
disease (including vision loss), heart disease, stroke, nerve
damage and even death. Due to the limitations and complexities of
insulin delivery systems, it can be difficult to achieve and
maintain balance in glucose control in patients with T1D.
Hypoglycemia remains a critical limiting factor in glycemic
management, and severe hypoglycemia can cause loss of
consciousness, coma, seizures, injury, and can be fatal.
About Creative Medical Technology Holdings
Medical Technology Holdings, Inc. is a biotechnology company
dedicated to the advancement of identifying and translating novel
biological therapeutics in the fields of immunotherapy,
endocrinology, urology, neurology and orthopedics and is traded on
NASDAQ under the ticker symbol CELZ. For further information about
the Company, please
Special Note Regarding Forward Looking
NASDAQ 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.
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SOURCE Creative Medical Technology Holdings, Inc.