AlloStem™ represents the first novel
allogenic cellular therapy in the dorsal artery of the pancreas in
the United
States
PHOENIX, Nov. 3, 2022
/PRNewswire/ -- Creative Medical Technology Holdings, Inc.
(NASDAQ: CELZ), an immuno-endocrine company working to
revolutionize care through the development of potentially
best-in-class regenerative therapeutics, today announced that the
U.S. Food and Drug Administration has cleared the Company's
Investigational New Drug (IND) application, enabling the Company to
proceed with initiating a clinical trial for Type 1 Diabetes using
AlloStem™.
AlloStem™ 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 (CELZ-201) is to evaluate
AlloStem™ in patients with newly diagnosed Type 1 Diabetes.
Patient recruitment is expected to begin in Q1 2023 with trial
commencement updates to follow.
The national principal investigator of the study is Camillo Ricordi, M.D. Dr. Ricordi is the Stacy
Joy Goodman Professor of Surgery, Distinguished Professor of
Medicine, Professor of Biomedical Engineering, and Microbiology and
Immunology at the University of Miami
in Florida, where he serves as the
Director of the Diabetes Research Institute and the Cell Transplant
Program.
Dr. Ricordi will give an update on the study today at the 8th
Perinatal Stem Cell Society Congress/Workshop at 9:00am EST.
"This is a milestone event for Creative Medical Technology
Holdings as it marks the Company's first IND clearance from the
FDA," said Timothy Warbington,
CEO. "We are excited to commence this trial under the
guidance of one of the world's most respected diabetes clinical
researchers and at a renowned research institute."
Mr. Warbington continued, "We are also excited to announce the
use of our proprietary AlloStem™ product in this study, as we
believe it validates our efforts in creating assets that support
our approach to developing immunotherapies. With this IND
clearance, we are accelerating our efforts to identify novel
biologics and develop therapies with the potential to effectively
treat unmet needs of patients. I wish to acknowledge our team and
collaborators for their hard work and dedication to this
program."
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
Creative 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
visit www.creativemedicaltechnology.com.
Forward Looking
Statements
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.