December, 15 2015 – Enrollment Initiated in CaverStem® Clinical Trial to Evaluate the Safety and Efficacy of Intra-cavernosal Administration of Non-Expanded Autologous Bone Marrow Cells in Treatment of Erectile Dysfunction
Creative Medical Health, Inc. announced that the first patient has been enrolled in the CaverStem® Clinical Trial to Evaluate the Safety and Efficacy of Intra-cavernosal Administration of Non-Expanded Autologous Bone Marrow Cells in Treatment of Erectile Dysfunction .
CaverStem® Study Objective
To evaluate safety and efficacy of autologous bone marrow mononuclear cells concentrated using a closed-system device, the Arteriocyte Magellan® device, and injected intra-cavernously in 20 patients aged 18 to 40 years of age diagnosed with erectile dysfunction. Safety will be determined based on device- and procedure-associated adverse events and blood chemistry measurements at baseline vs. follow up visits at one, three, six, and twelve months post-treatment. Efficacy will be evaluated at baseline and follow up visits by Doppler ultrasound, dynamic infusion cavernosometry, and blood work. The study will determine whether injection of bone marrow cells intra-cavernously is a clinically feasible therapeutic approach for treating erectile dysfunction.
CaverStem® Study Location
The CaverStem® trial being conducted by Dr. Jacob Rajfer and the LA Biomed research team at UCLA / Harbor Medical Center located in Torrance, California.
About LA Biomed
Founded in 1952, LA BioMed is one of the country’s leading nonprofit independent biomedical research institutes. It has approximately 100 principal researchers conducting studies into improved diagnostics and treatments for cancer, inherited diseases, infectious diseases, illnesses caused by environmental factors and more. It also educates young scientists and provides community services, including prenatal counseling and childhood nutrition programs. LA BioMed is academically affiliated with the David Geffen School of Medicine at UCLA and located on the campus of Harbor-UCLA Medical Center. For more information, please visit www.LABioMed.org
About Dr. Jacob Rajfer
Jacob Rajfer, M.D. has made UCLA one of the top basic science research centers in the field of impotence, specializing in the molecular events surrounding the production of nitric oxide, the chemical responsible for the erectile process. Since 1980, Dr. Rajfer has headed the clinical and teaching programs in Urology at the Harbor-UCLA Medical Center. Many specialties within Urology– including pediatrics, renal transplantation, oncology and andrology–have been expanded at Harbor and a number of important discoveries have resulted from the clinical and research activities at Harbor under Dr. Rajfer’s guidance. It was these research activities that led to the discovery at UCLA of what chemicals cause an erection and explained in detail how drugs like Viagra work in helping men with impotence.
In addition to serving as Chief of Urology at Harbor-UCLA Medical Center, Dr. Rajfer is a Professor of Urology at the David Geffen School of Medicine’s Department of Urology. He received his medical degree from Northwestern University in Chicago, Illinois and completed his Internship at LA County-USC Medical Center, Los Angeles, California. Dr. Rajfer completed a Surgery Residency at St. Josephs Hospital in Denver, Colorado, and served as Senior Assistant Resident in Urology at The Johns Hopkins Hospital, Baltimore, Maryland, where he went on to become Chief Resident in Urology. Dr. Rajfer also served as Research Fellow in Urology at the Johns Hopkins University School of Medicine. He is Board Certified by the American Board of Urology and holds a number of important patents for medical discoveries related to the field of urology.
Creative Medical Health, Inc. owns U.S. patent #20,090,311,223, titled “Treatment of Erectile Dysfunction by Stem Cell Therapy,” which covers the use of various stem cells for treatment of patients who do not respond to Viagra, Cialis and Levitra. In contrast to pharmaceutical agents, the CaverStem® treatment developed by Creative Medical Health, Inc. involves regenerating the blood vessels and smooth muscle of the penis, thus offering the possibility of permanent regeneration, not a temporary remedy.
The medical procedure involves extracting stem cells from the patient’s own bone marrow, processing them and subsequent administration into the penis. A peer-reviewed study describing the first patient treated with this procedure may be found at http://www.translational-medicine.com/content/pdf/1479-5876-11-139.pdf.
“There are approximately 30 million patients with erectile dysfunction in the USA. Of these, 30% do not respond to pharmaceutical interventions, which represents approximately 9 million potential patients that could benefit from our approach,” stated Timothy Warbington, CEO of Creative Medical Health, Inc. “Given that this patient group has limited alternatives besides costly implants and injections before intercourse, which can be associated with horrific side effects, we believe it is our responsibility to accelerate development of this program in a timely manner.”
The use of bone marrow stem cells is currently part of medical practice in bone marrow transplantation, and is currently in advanced clinical trials for conditions including heart failure, peripheral artery disease and stroke. Creative Medical Health, Inc. is the first to patent and subsequently clinically validate the feasibility of applying this form of stem cell therapy to urological conditions.
About Creative Medical Health, Inc.:
CREATIVE MEDICAL HEALTH, INC., in collaboration with leading U.S. universities, physicians and scientists, has developed and tested our patented treatment of various medical conditions with stem cell technology. Our area of concentration is the scientific and evidence-based approach to the approximately $30 billion per year complementary and alternative medicine market in the United States and $250 billion worldwide market. For more information about Creative Medical Technologies go to www.creativemedicalhealth.com.
Creative Medical Health, Inc.
Tim Warbington, 602-680-7439