PHOENIX, and LOS ANGELES, Dec. 18, 2017 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. (OTCQB ticker symbol CELZ) announced today initiation of patient treatments using its patented Caverstem™ procedure by Dr. Alexander Gershman.
Dr. Alexander Gershman, Director of The Institute of Advanced Urology at the Cedars-Sinai Medical Tower; Director of Urologic Laparoscopy in the Division of Urology, Harbor-UCLA Medical Center, began treating patients with the procedure, which involves extraction of a small amount of bone marrow, concentration of bone marrow derived stem cells, and subsequent administration to the patient within less than an hour.
"There is much excitement about stem cells revolutionizing many aspects of medicine. I am enthusiastic to be offering this cutting edge procedure to my patients, for which previous therapies have failed or are too invasive," said Dr. Gershman. "Numerous publications and a recent clinical trial at the Los Angeles Biomedical Institute at Harbor – UCLA Hospital in Torrance, CA, support the safety and feasibility of the Caverstem™ procedure. The biological basis of the bone marrow based treatment is that in patients with drug non-responsive erectile dysfunction, there is a deficit in function of smooth muscle and blood vessel cells. By administering the patient's own stem cells we aim to rebuild these damaged tissues, and thereby restore erectile function."
Creative Medical Health Technology Holdings is offering the Caverstem™ procedure to selected urologists in the USA, which qualify according to the Company's criteria. Approximately 30% of the 30,000,000 patients suffering from erectile dysfunction do not respond to drugs like Viagra, Cialis and Levitra, in part due to an underlying degeneration of the biological machinery needed to achieve erections.
"We are pleased to have received such enthusiasm from one of the Opinion Leaders of the Urology community in the first 30 days of commercialization and anticipate similar responses as we expand our physician base throughout the United States" said Timothy Warbington, President and CEO of Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings Announces Commercialization of patented Stem Cell Procedure for Erectile Dysfunction
PHOENIX, Oct. 19, 2017
PHOENIX, Oct. 19, 2017 /PRNewswire/ -- Creative Medical Technology Holdings (OTCQB – CELZ) announced today completion of the safety data analysis on 20 patients with pharmacologically-resistant erectile dysfunction treated with the Company's patented CaverStem™ procedure.
The trial, sponsored by Creative Medical Technology Holdings, was conducted at the University of California Los Angeles Harbor Hospital/LA Biomed under Institutional Review Board (IRB) approval. An independent medical safety monitor was also appointed to review the patient data for safety and feasibility of administering bone marrow derived stem cells into patients with erectile dysfunction. The goal of this procedure is to regenerate blood vessels and smooth muscle, parts of the penis that are not functioning properly in this patient population.
"Based on establishment of safety of the CaverStem™ procedure in a formal university-based clinical trial, and independent confirmation of efficacy in an European clinical trial1, we have launched commercialization for the CaverStem™ procedure," said Timothy Warbington, President and Chief Executive Officer of Creative Medical Technology Holdings. "Amongst other top urologists, we have recruited a world-renowned urologist as a lead physician to roll-out the procedure. We anticipate that the procedure will be available to patients that meet the eligibility criteria within the next 60 days."
According to the National Institutes of Health, approximately 30 million men in the United States suffer from Erectile Dysfunction2, of which 9 million do not respond to pharmacological treatments such as Viagra, Levitra and Cialis.
"The CaverStem™ procedure involves obtaining a small amount of bone marrow from the patient, purifying the stem cells using a closed system device that is FDA cleared, and then administering these cells in the same procedure into the patient's penis," said Thomas Ichim, Ph.D, Chief Scientific Officer and Co-Founder of the Company. "Having published the first peer-reviewed paper on this procedure back in 2013 together with internationally renowned urologists and stem cell experts3, it is very exciting for me to watch this translate from bench to bedside."
Creative Medical Technology Holdings Expands Stem Cell Therapeutic Platform by Entry into Field of Stroke and Neurodegeneration
PHOENIX, Oct. 16, 2017
PHOENIX, Oct. 16, 2017 /PRNewswire/ -- Creative Medical Technology Holdings (OTCQB: CELZ) announced today filing of a patent application using a combination of an FDA approved drug together with the patient's own bone marrow derived stem cells for the treatment of stroke. The patent, entitled "Autologous Bone Marrow Mononuclear Cells as a Substrate for Enhancement of Neuroregenerative Therapy", covers the use of the patient's bone marrow stem cells, together with an FDA approved drug, to stimulate the naturally occurring regenerative processes after certain types of strokes. The Company has currently two issued patents using the patient's own bone marrow stem cells covering disc regeneration #9,598,673, and erectile dysfunction #8,372,797. The Company has recently reported completion of enrollment in its clinical trial for erectile dysfunction.
"Stroke represents one of those situations where the body's own stem cells leave the bone marrow, enter circulation, and attempt to heal the damaged brain areas. It is documented that patients in which larger numbers of bone marrow stem cells enter circulation, have a better prognosis as compared to patients in which stroke induces a lower number of stem cells to enter circulation1," said Thomas Ichim, Ph.D, Chief Scientific Officer of Creative Medical Technology Holdings. "In the current patent we augment the naturally occurring approach by extracting stem cells from the bone marrow, placing them in circulation, and administering an FDA approved drug to enhance their activity. We are particularly excited by the fact that this approach falls under the practice of medicine and does not require full clinical trials for commercialization."
Creative Medical Technology Holdings focuses on rapid commercialization-based approaches using the patient's own stem cells under the practice of medicine.
"Stroke is a devastating condition, which is estimated to represent an over $20 billion dollar annual market in the USA alone. We are confident that our new approach to addressing stroke will provide a new tool in the hands of neurologists, which will allow for a 'natural-based' regenerative approach to this condition," said Timothy Warbington, President and Chief Executive Officer of the Company. "Given that we have been previously successful at having patents issued using autologous approaches, as well as our rapid entry into the clinic, we are excited to open up yet another market for our technology platform."
Creative Medical Technology Holdings Achieves 100% Patient Enrollment in CaverstemTM Clinical Trial for Stem Cell Treatment of Erectile Dysfunction
PHOENIX, Aug. 28, 2017
PHOENIX, Aug. 28, 2017 /PRNewswire/ -- Creative Medical Technology Holdings Inc. (OTCQB ticker symbol CELZ) announced today completion of enrollment in the Company's clinical trial assessing safety and efficacy of its CaverstemTM procedure to treat erectile dysfunction in patients who do not respond to currently available treatments. Approximately 30% of the 30,000,000 patients suffering from erectile dysfunction do not respond to drugs like Viagra, Cialis and Levitra, in part due to an underlying degeneration of the biological machinery needed to achieve erections.
"The CaverstemTM procedure, which uses the patient's own bone marrow derived stem cells to induce arterial and venous regeneration, is an outpatient procedure able to be conducted by Urologists in their medical facilities. We are using a patient's own cells and we do not manipulate the stem cells through the use of chemicals, growth factors or expansion and have experienced no procedure-related safety issues," said Dr. Thomas Ichim Co-Founder and Chief Scientific Officer of Creative Medical Technology Holdings, Inc.
The clinical trial covering patients ages 18 to 80 received Institutional Review Board (IRB) approval in December 2016. The trial is sponsored by us based on our patented technology and is conducted by Dr. Jacob Rajfer, Principal Investigator and Los Angeles Biomedical Institute at Harbor – UCLA Hospital in Torrance, CA.
"I am pleased with the expedience and efficiency at which enrollment was reached. As someone who regularly sees patients suffering from treatment non-responsive erectile dysfunction, I am excited to see the development of a novel approach to treating this condition using the patient's own natural regenerative processes," said Dr. Alexander Gershman, member of the Company's Scientific Advisory Board and Director of Institute of Advanced Urology at the Cedars-Sinai Medical Tower; Director of Urologic Laparoscopy in the Division of Urology, Harbor-UCLA Medical Center."
"We are very fortunate to work with the expert team at Los Angeles Biomedical Institute - UCLA/Harbor Hospital who have done an outstanding job with subject recruitment, screening, treatment and follow-up. We firmly believe that we are on schedule for commercialization of the Caverstem TM procedure through publication and presentation of trial results, marketing, licensing, training and sales in 2018," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings Inc.
Creative Medical Technology Holdings, Inc. Files Patent on AmnioStem™ Mediated Immune Reprogramming for Stroke
PHOENIX and SAN DIEGO, May 24, 2017
PHOENIX and SAN DIEGO, May 24, 2017 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. (OTCQB: CELZ) (the "Company") announced today the filing of a patent application covering a novel means of suppressing inflammation associated with stroke by reprogramming immune cells of the stroke victim.
The patent application teaches ways of using the Company's patented AmnioStem™ allogeneic stem cell to 'educate' immune cells from stroke patients so as to reduce inflammation associated with stroke. By reducing inflammation, the Company hopes to develop novel means of increasing efficacy of therapeutic agents in stroke patients.
"We are highly enthusiastic with our current data, which seems to suggest that AmnioStem™cells are not only capable of inducing regeneration of injured brains, but also can be used to 'reprogram' immune system cells of patients in order to reduce inflammation that occurs subsequent to stroke," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. "Working together with immunologists, neurologists, and stem cell experts, we are fortunate to have a team that can attack the problem of stroke in a multidisciplinary manner."
It is known that the immune system contributes to the deterioration of brain functions after a stroke. For example, studies in the mouse model of stroke have shown that if certain immune cells are depleted, the neurological impact of a stroke is diminished.1 It is also known that part of the therapeutic activities of stem cells in a stroke are mediated by alterations of the immune system.2
"We are confident that the novel findings presented in the patent application will pave the way for using AmnioStemTM treated patient immune cells as a means of suppressing pathological responses, which is applicable not only to strokes, but to a wide variety of neuroinflammatory conditions including multiple sclerosis and traumatic brain injuries," said Thomas lchim, Ph.D., Chief Scientific Officer of Creative Medical Technology Holdings.
1 Belinga et al. Splenectomy following MCAO inhibits the TLR4-NF-KB signaling pathway and protects the brain from neurodegeneration in rats. J Neuroimmunol. 2016 Apr 15; 293:105-13
2 Cheng et al. Human umbilical cord mesenchymal stem cells protect against ischemic brain injury in mouse by regulating peripheral immunoinflammation. Brain Res. 2015 Jan 12;1594:293-304.
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