July 23, 2015 – John F. Wolf, M.D. Human Subjects Committee (Institutional Review Board) Approves 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. (CMH) announced the John F. Wolf, M.D. Human Subjects Committee has authorized CMH and Dr. Jacob Rajfer to proceed with 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.
“We are very pleased the LA Biomed Institutional Review Board has authorized the study to proceed. CMH expects to initiate the study in November 2015 after we have selected a CRO to oversee the study and make final preparations for study initiation.” stated Timothy Warbington, CEO of Creative Medical Health, Inc.
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