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Cryo-Cell International, Inc., the worlds first cord blood bank, announced today that it has provided funding to complete an Investigational New Drug Application (IND) for a FDA approved Phase I clinical trial for patients that have amyotrophic lateral sclerosis (ALS or Lou Gehrig's) disease using umbilical cord blood cells.
Oldsmar, FL (PRWEB) August 22, 2014
This funding was made through an additional investment in Cryo-Cells cell therapy research affiliate, Saneron CCEL Therapeutics, Inc. in the form of a convertible promissory note purchase agreement.
Cryo-Cell is extremely pleased to collaborate with Saneron on several fronts to enable the filing of an IND, which we hope will lead to regenerative therapies using cord blood to treat devastating neurodegenerative diseases such as ALS, David Portnoy, Chairman and Co-CEO of Cryo-Cell, stated. He continued, Although this is only the next step, if Sanerons cord blood product ultimately is successfully approved by the FDA to treat ALS, Saneron will indeed prove to be a very valuable corporate asset for Cryo-Cell.
With these funds, Saneron anticipates filing an IND application in the fourth quarter of 2014. The IND for the FDA will be for a Phase I Safety trial enrolling 12 patients that have been diagnosed with ALS, said Nicole Kuzmin-Nichols, President & COO of Saneron. The study will involve the administration of U-CORD-CELL®, Sanerons proprietary mononuclear enriched cell fraction of umbilical cord blood to be processed in Cryo-Cells GMP laboratory.
Sanerons sponsored preclinical studies using U-CORD-CELL® have demonstrated efficacy in various disease models including: ALS, stroke, myocardial infarction, and Alzheimers disease. In particular, the Cryo-Cell affiliate has demonstrated that a single intravenous administration of U-CORD-CELL® can delay disease progression and extend lifespan in a preclinical ALS animal model.
Cryo-Cell is excited that Sanerons U-CORD-CELL® processed cell fraction has shown improved efficacy in the ALS preclinical model when previously compared to commonly utilized cord blood cell processing procedures used in the cord blood banking industry.
ALS is a devastating disease that is a rapidly progressive, invariably fatal neurological disease that attacks the nerve cells (neurons) responsible for controlling voluntary muscles (muscle action we are able to control, such as those in the arms, legs, and face). The disease belongs to a group of disorders known as motor neuron diseases, which are characterized by the gradual degeneration and death of motor neurons. According to the ALS Association, in the U.S., approximately 30,000 people have ALS and each year 5,000 people are diagnosed with the disease.
About Cryo-Cell International
Founded in 1989, (OTCQB:CCEL) Cryo-Cell International, Inc. is the world's first private cord blood bank. More than 500,000 parents from 87 countries trust Cryo-Cell to preserve their family members' stem cells. Cryo-Cell's mission is to provide clients with state-of-the-art stem cell cryopreservation services and support the advancement of regenerative medicine. Cryo-Cell operates in a facility that is FDA registered, cGMP-/cGTP-compliant and is licensed in all states requiring licensure. Besides being AABB accredited as a cord blood facility, Cryo-Cell is also the first U.S. (for private use only) cord blood bank to receive FACT accreditation for adhering to the most stringent cord blood quality standards set by any internationally recognized, independent accrediting organization. In addition, Cryo-Cell is ISO 9001:2008 certified by BSI, an internationally recognized, quality assessment organization. Cryo-Cell is a publicly traded company, OTCQB: CCEL. For more information, please visit http://www.cryo-cell.com.
About Saneron CCEL Therapeutics, Inc.
Saneron CCEL Therapeutics, Inc. is a biotechnology R&D company focused on neurological and cardiac cell therapy for the early intervention and treatment of several devastating or deadly diseases which lack adequate treatment options. Saneron, a University of South Florida spin-out company, is located at the Tampa Bay Technology Incubator. Saneron is committed to providing readily available, noncontroversial stem cells for cellular therapies and has patented and patent-pending technology relating to its platform technology of umbilical cord blood and Sertoli cells. Please visit http://www.saneron-ccel.com for more information.
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