Sep 10, 2019

First Study Testing Cell Therapy for Rotator Cuff Surgery Launches at HSS

Scott A. Rodeo, MD, a sports medicine surgeon and clinician-scientist at Hospital for Special Surgery (HSS) has launched a clinical trial of an experimental engineered cell therapy that aims to promote better healing of rotator cuff tears after surgery. 

The rotator cuff is a collection of muscles and tendons at the shoulder joint that allows it to move. Overuse from repetitive overhead activities like swimming, tennis, or pitching a baseball, or acute injuries, can cause tears in the muscles or tendons of the rotator cuff. 

“Arthroscopic shoulder surgery for rotator cuff tears is effective for relieving pain, restoring function and improving quality of life, but up to 25% of patients show incomplete or failed healing on imaging,” says Dr. Rodeo. “The frequency of incomplete or failed healing is more pronounced in patients over the age of 60. That matters because more people today want to stay active as they age.” 

Many tissues in the body, including muscles and tendons, harbor stem cells that have the ability to form new tissues. The new clinical trial will test whether injecting an experimental cell therapy into both the muscle and the tendon of an injured rotator cuff will stimulate stem cell activity and promote better repair. 

The engineered cell therapy product is E-CEL UVEC®,  produced by San Diego based Angiocrine Bioscience, Inc. The investigational product consists of endothelial cells derived from the walls of the blood vessels of human umbilical cords that have been genetically modified to maintain their stability and their regenerative properties. The US Food and Drug Administration has granted the cell therapy Investigational New Drug (IND) status.  

In a previous basic science study led by Dr. Rodeo, the cell therapy showed accelerated healing and an increase in the strength of the tendon attachment at the repair site, with no observable side effects, compared to surgery alone.

In the new clinical trial, patients with full-thickness rotator cuff tears who undergo arthroscopic surgical repair will receive two injections of the cell therapy: one into the tendon and one into the adjacent muscle. The study is open-label, meaning that all volunteers will know that they received the cell therapy. 

The primary objective of the trial is to evaluate the safety of the cell therapy over 12 months. Dr. Rodeo and his research team will use blood tests to check whether the experimental cells have migrated away from the rotator cuff repair site. The investigators will also evaluate patients’ symptoms as well as shoulder strength, motion and healing as measured by MRI, ultrasound and patients’ reports about their progress. 

“Improving patients’ symptoms with standard rotator cuff surgery is good, but strength improvements are less predictable,” Dr. Rodeo says. “Identification of new ways to improve healing and muscle function would represent a significant advance in the treatment of rotator cuff tendon tears.” 

“We continue to enjoy working with Dr. Rodeo and his team on this long-term collaborative effort and look forward to providing support for this exciting new therapeutic application of E-CEL UVEC cells,” commented Paul Finnegan, MD, Angiocrine’s CEO.

The study opened September 1, 2019, with the goal of recruiting up to 20 patients ages 45 to 70 with full-thickness rotator cuff tears confirmed by physical examination and MRI. Eligible participants must already have tried and failed standard non-operative approaches, including a minimum of three months of physical therapy, oral anti-inflammatory medications, or a steroid injection. 

For more information about the clinical trial (NCT04057833), please contact Camila Carballo, PhD, at carballoc@hss.edu or Daniel Edon, MS, at edond@hss.edu.  

About HSS

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the tenth consecutive year), No. 3 in rheumatology by U.S. News & World Report (2019-2020), and named a leader in pediatric orthopedics by U.S. News & World Report “Best Children’s Hospitals” list (2019-2020). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In addition, HSS will be opening a new facility in Florida in early 2020. In 2018, HSS provided care to 139,000 patients and performed more than 32,000 surgical procedures, and people from all 50 U.S. states and 80 countries travelled to receive care at HSS. There were more than 37,000 pediatric visits to the HSS Lerner Children’s Pavilion for treatment by a team of interdisciplinary experts. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is the world’s leading provider of education on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.

About Angiocrine Bioscience, Inc.

Angiocrine Bioscience is an innovative, early clinical stage biotechnology company harnessing the power of engineered endothelial cells to heal and rejuvenate patients with serious medical conditions.  The company is developing a line of engineered endothelial cell (E-CEL® ) therapies for treating numerous life-threatening hematology and oncology conditions, as well as, in the field of organ and tissue regeneration. The core technology is founded on breakthroughs in vascular biology and stem cell research honed from decades of research by Professor Shahin Rafii and his laboratory at the Ansary Stem Cell Institute at Weill Cornell Medical College in New York City.  Angiocrine Bioscience is at the front line in the next great medical revolution of utilizing living cells to improve the health and quality of life for patients in need.

May 17, 2017

Weill Cornell Medicine Creates a Renewable Supply of Blood Stem Cells That Hold the Promise of Treatment and Potential Cures for Multiple Disorders

Technology Offers New Approach to Regenerating the Blood and Immune System

SAN DIEGO, CA –A team of researchers at Weill Cornell Medicine have discovered an innovative method to make an unlimited supply of healthy blood and immune cells from the readily available cells that line blood vessels. The work published in Nature today is the culmination of efforts by a team of researchers led by Professor Shahin Rafii MD, director of the Ansary Stem Cell Institute, chief of the Division of Regenerative Medicine and the scientific founder of Angiocrine Bioscience.

Stem cells that produce cells that comprise the blood and immune system (hematopoietic stem cells) are not only critical to human vitality and health but also can be used therapeutically to treat and even cure various diseases from cancer to devastating genetic diseases, such as sickle cell anemia and primary immune deficiency (a.k.a. bubble baby syndrome). Ample, high-quality generation of hematopoietic stem cells has been a ‘holy grail’ of modern medical science.

As described in the publication, the team at Weill Cornell Medicine have discovered a novel system for reprogramming endothelial cells into hematopoeitic stem cells that can regenerate the blood cells and the immune system. Endothelial cells line the blood vessels throughout the body and are easily obtainable. Two distinct methodologies are used to accomplish this feat: a) reprogramming of endothelial cells with four genes that encode proteins into hematopoeitic stem cells; and, b) utilizing another specialized type of endothelial cell (E-CELTM) that enables clinical and commercial scale production of blood and immune system forming stem cells. Both technologies were invented by Professor Rafii and his team, and exclusively licensed by Angiocrine Bioscience, Inc.

“The potential clinical applications of this new powerful technology is vast,” commented Paul Finnegan MD, Chief Executive Officer of Angiocrine Bioscience. “Just imagine the possibilities generated by a process that can produce your own stem cells, for example skin, so you can treat or even cure yourself. We applaud the groundbreaking work that Professor Rafii and his team continues to produce at Weill Cornell Medical, to bring the future of regenerative medicine within our reach, near-term.”

About Angiocrine Bioscience Inc.
Angiocrine Bioscience is a privately held San Diego based biopharmaceutical company and a world-leader in regenerative engineered endothelial cells. Angiocrine’s proprietary E-CEL™ cells simulate the vascular stem cell niche, special locations within vital organs where certain endothelial cells work with the organ’s stem cells to start the regenerative and repair process in our body. The Ψ Psi-CEL™ technology enables the production of blood and immune system forming (hematopoietic) stem cells from endothelial cells. Together, they represent a potentially transformative new approach to treatment and cure of various diseases. Angiocrine’s approach is unique and based on over twenty years of research in vascular and regenerative biology by its scientific founder, Professor Shahin Rafii MD of Weill Cornell Medical.

For additional information, please contact:

Angiocrine Bioscience, Inc.
John R. Jaskowiak
(408) 646-2265
jjaskowiak@angiocrinebio.com

Jan 11, 2016

Angiocrine Bioscience Announces Collaboration for Clinical Cell Manufacturing Platform with Terumo BCT

Improved Scalability for E-CEL™ Manufacturing with Quantum® Cell Expansion System

SAN DIEGO, CA—(Business Wire) Angiocrine Bioscience Inc. today announced a three-year collaboration agreement with Terumo BCT Inc., a global leader in blood component, therapeutic apheresis and cellular technologies, to implement Terumo BCT’s Quantum Cell Expansion System as a manufacturing platform for its E-CEL™ technology and therapeutic candidates. The Quantum system, a state-of-the-art, functionally closed hollow-fiber bioreactor technology, streamlines the cell culture process and furthers the research and development of Angiocrine’s cell therapy products by enhancing process scalability, increasing reproducibility and reducing costs. “As we advanced our discovery and pre-clinical therapeutic programs, it was critical to identify a key collaborator that would help us streamline our processes and enable manufacturing scale up in a predictable and effective manner. The early adoption of an automated cell expansion platform, the Quantum system, in our research and development activities will accelerate our pace as we work to rapidly advance our therapeutic candidates into the clinic, and we are keen to work with Terumo BCT to leverage their expertise in cell culture automation and scale up,” commented Paul Finnegan, MD, Angiocrine’s CEO.

Cell culture processes can be optimized and configured on the Quantum system manufacturing platform to expand several cell types, including some used in ongoing clinical trials in Europe. Angiocrine believes this helps develop various potential therapeutic indications being addressed by Angiocrine’s E-CEL technology. The combination of protocol flexibility and process control through automation provides a significant advantage over manual flask-based methods and positions the Quantum system ideal for a range of production scenarios from bench top research to commercial manufacturing. “Angiocrine Bioscience has a novel approach to regenerative medicine with its E-CEL technology and we are excited about working with them to achieve clinical scale production”, added Dave Flaten, Vice President, Cell Processing, Terumo BCT.

About Angiocrine Bioscience Inc.
Angiocrine Bioscience is a world-leader in genetically-modified endothelial cell-based technology (the E-CEL™ Technology) which has multiple applications in regenerative medicine. Angiocrine’s approach is unique and based on over twenty years of research in vascular and regenerative biology. We aim to transform the standards of medical practice through our rationally designed, inspired by nature, therapeutic platforms designed to drive resident stem cell renewal in a variety of disease settings. Angiocrine’s core technology is licensed from Weill Cornell Medical College and was invented and developed by Professor Shahin Rafii, MD. His work related to Angiocrine technology has been published in numerous peer-reviewed journals, including Nature, Cell and Blood.

About Terumo BCT
Terumo BCT is a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

For additional information, please contact:

Angiocrine Bioscience, Inc.
John R. Jaskowiak
(408) 646-2265
jjaskowiak@angiocrinebio.com

Aug 21, 2014

Angiocrine Bioscience Licenses New Stem Cell Technology From Weill Cornell Medical College

Technology Offers Safer Approach to Stem Cell Transplantation

NEW YORK, NY – (Business Wire) Angiocrine Bioscience, Inc. announced today that it has licensed the rights to a new technology developed by a team of researchers at the Ansary Stem Cell Institute at Weill Cornell Medical College. The team was led by Dr. Shahin Rafii, director of the Ansary Stem Cell Institute, professor of medicine, genetic medicine and reproductive medicine, and a founder of Angiocrine Bioscience. This scientific advance, reported in the July 2 issue of Nature, could potentially lead to therapies for patients with blood disorders from their own cells.

This technology provides a means of converting a patient’s own vascular cells, known as endothelial cells, directly into blood stem cells. The endothelial cells are acquired from a biopsied piece of skin and are then “educated” on a bed of VeraVecTM cells (proprietary to Angiocrine Bioscience) to form multipotent blood cells that are capable of producing red cells that carry oxygen, white cells that provide immunity, and platelets to prevent bleeding. This approach could potentially provide an abundant and safe source of new blood stem cells capable of treating a variety of diseases without the risk of graft versus host disease, a serious, life-threatening complication often associated with stem cell transplants derived from a donor.

“We hope that our method will offer the first safe technology to treat a wide spectrum of serious disorders. The VeraVecTM cells form a nurturing niche for the survival and growth of the reprogrammed blood cells, similar to what happens developmentally during blood production. A particularly important aspect of this study was that the reprogrammed cells engrafted in the bone marrow when implanted into rodents and morphed into the various types of blood cells,” said Dr. Rafii.

“This technology nicely complements our efforts in applying our VeraVecTMplatform to the expansion of umbilical cord blood stem cells, another approach toward making stem cell transplant safer and more broadly available to patients in need, ” added Geoff Davis, Angiocrine’s CEO.

About Angiocrine Bioscience, Inc.

Angiocrine Bioscience is a privately held biotech company focused on applying vascular biology to new therapeutic applications. Angiocrine’s VeraVecTM technology platform is based on endothelial cells that have been genetically modified such that they can be rapidly and durably expanded in culture. Because these cells secrete and display factors essential for stem cell growth and proliferation, they can be used to support cell-based therapies, stem cell transplant, and regenerative medicine applications. VeraVecTM products are currently marketed for research-use only purposes to academic laboratories, medical research institutes, and pharmaceutical and biotechnology companies.

For additional information, please contact:

Angiocrine Bioscience, Inc.
John R. Jaskowiak
(302) 475-8645
jjaskowiak@angiocrinebio.com