Press Releases

Endonovo Therapeutics Announces Method for Large Scale Expansion of Cord Blood

Download PDF

Technology Could Increase Safety and Allow for a 10-Fold Increase in Cord Blood Transplants

LOS ANGELES, CA--(Marketwired - Oct 1, 2015) - Endonovo Therapeutics, Inc. (OTCQB: ENDV) ("Endonovo" or the "Company"), an innovative biotechnology company developing bioelectronic products and therapies for regenerative medicine, announced today the development of a large-scale method for the expansion of umbilical cord blood.

Each year, an estimated 60,000 patients with leukemia and lymphoma need bone marrow transplantation. However, only 25,000 of those patients actually receive a transplant, primarily because the other 35,000 patients are unable to find a fully matched bone marrow donor.

Umbilical cord blood from newborn children is an excellent source of hematopoietic stem cells for stem cell transplants because their immune system is still immature and the stem cells have a lower probability of inducing an adverse immune response in patients. Furthermore, a perfect immunological match between donor and recipient is not necessary, unlike in bone marrow transplants.

However, in most cases a unit of umbilical cord blood contains too few stem cells to treat an adult patient and its use is confined above all to the treatment of children. Numerous patients have better matched cord blood products available (5/6 or 6/6 HLA match), however those products have low cell doses and are not suitable for use in adult patients. This is one of the reasons why less than 3 percent of cord blood collected in the United States is ever used; the rest sits uselessly in blood banks, according to a report in Genetics and Engineering News.

Endonovo's technology could allow for a 10x increase in adult stem cell transplants and potentially increase the safety of these treatments by allowing for the expansion of sub-optimal cord blood products that are better matched to patients.

Endonovo's technology consists of the co-culturing of cord blood mononuclear cells with a portion of the umbilical cord in a three-dimensional rotating wall vessel (RWV) bioreactor, allowing for the expansion of hematopoietic stem cells. The expanded cord blood products would meet the minimal cell requirements for the use of cord blood in adults and potentially result in enhanced engraftment and less toxicities, such as graft versus host disease (GVHD) that occur in lower level HLA matched cord blood units.

Although several other groups have shown the ability to expand cord blood products using co-cultures with a variety of cells, including bone marrow mesenchymal stem cells, previous techniques are still confined to small scale cultures that do not meet the needs of large clinical trials or commercialization.

Endonovo's technology allows for the large scale expansion of cord blood products using a three-dimensional RWV bioreactor that overcomes many of the limitations of static cultures and conventional bioreactors, including the continuous replacement and gentle mixing of media, low shear and low concentration gradients.

"Our technology improves upon the use of co-cultures to expand cord blood products by providing a large scale bioreactor that is particularly suited to expand hematopoietic cells and supports co-culture methods by bringing different cell types of different cell sizes and density together simply and efficiently," stated Endonovo Chief Scientist, Dr. Donnie Rudd, PhD. "The use of the RWV bioreactor alone can produce an over 400-fold expansion of total cell numbers, an over 30-fold expansion of CD34+ cells and an over 20-fold expansion of CFU-GM cells, which give rise to critical infection-fighting granulocytes in as few as 8 days. The combination of the two technologies results in a relatively simple large scale method of expanding cord blood products."

"This technology could allow thousands of patients around the world access to safer and more effective stem cell transplants," added Endonovo CEO, Alan Collier.

"The wide spread use of cord blood is limited not only by a lack of matched units with adequate cell numbers, but also largely by costs, as a single unit of cord blood costs on average $39,000 and most adults require the use of two units. Furthermore, the cost of the procedure can be up to $300,000. We look forward to exploring licensing and partnering opportunities to commercialize this technology and potentially lower the cost of cord blood transplants," concluded Mr. Collier.

About Endonovo Therapeutics
Endonovo Therapeutics, Inc. is an innovative biotechnology company developing bioelectronic devices and therapies for regenerative medicine. The Company's bioelectronic therapies are non-invasive and non-implantable devices designed to treat and prevent vital organ failure through the reduction of inflammation, cell death, and the promotion of regeneration. Endonovo's initial concentration is on the treatment of acute and chronic inflammatory conditions of the liver.

Safe Harbor Statement
This press release contains information that constitutes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, trends, analysis, and other information contained in this press release including words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," and other similar expressions of opinion, constitute forward-looking statements. Any such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any future results described within the forward-looking statements. Risk factors that could contribute to such differences include those matters more fully disclosed in the Company's reports filed with the Securities and Exchange Commission. The forward-looking information provided herein represents the Company's estimates as of the date of the press release, and subsequent events and developments may cause the Company's estimates to change. The Company specifically disclaims any obligation to update the forward-looking information in the future. Therefore, this forward-looking information should not be relied upon as representing the Company's estimates of its future financial performance as of any date subsequent to the date of this press release.

Investor Relations Contact:
Endonovo Therapeutics, Inc.
Mr. Steven Barnes
Vice President of Investor Relations
(800) 701-1223, Ext. 108