Industry Insider News

Department of Defense Awards Grant For Stem Cell Wound Care Research

The U.S. Department of Defense (DOD) has awarded $3.8 million to a consortium that is expected to advance certain research pertaining to stem cell-created skin grafts for the treatment of inherited skin diseases into the manufacturing stage, according to officials from the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine, whose scientists are among the consortium. The major grant for the Epidermolysis Bullosa (EB) iPS Cell Consortium, which includes research teams from the University of Colorado Anschutz Medical Campus, Stanford University School of Medicine, and Columbia University Medical Center, will move production of stem cells onto the Anschutz campus, officials said. The grant reportedly follows recent awards for the same investigators by the 21st Century Cures Act and the California Institute of Regenerative Medicine, boosting research that could benefit those who live with EB and other chronic wound patients. The award will also reportedly allow the EB research team to further investigate best practices in manufacturing for larger-scale production of stem cell-created skin grafts.

Earlier this year, Anschutz’s EB researchers also reported a more efficient approach to reprogramming a patient’s diseased skin cells into stem cells, raising hopes for future clinical trials and potential cures, officials said. In announcing the new grant, DOD reviewers said, “This study is based on the strongest cutting-edge scientific rationale in the field of wound care and dermatology. It is also a collaborative effort among top physician-scientists, scientists, healthcare providers, EB patients, families, and charities across the United States.”

According to a recent report by Anschutz officials, the goal is to move the technology from the laboratory into clinical trials. Dennis Roop, PhD, director of the Gates Center at Anschutz, will serve as a lead researcher on the team, which also includes Igor Kogut, PhD, and Ganna Bilousova, PhD. The consortium is funded by the U.S.-based EB Research Partnership, EB Medical Research Foundation, and Sohana Research Fund from Great Britain, according to Anschutz officials. Visit www.cuanschutztoday.org to learn more information. 

TissueTech Earns Patent for Umbilical Cord & Amniotic Membrane Product

Officials at TissueTech^® Inc., Miami, FL, a developer of regenerative amniotic tissue-based products and the parent company of Amniox Medical Inc. and Bio-Tissue Inc., have announced the company has been awarded a patent by the U.S. Patent Trademark Office for the use of a gel composition comprising morselized placental amniotic membrane and/or morselized umbilical cord as a method for treating ocular wounds or repairing damaged ocular tissue.

“TissueTech has been the leader in the development and clinical application of amniotic membrane transplantation for the treatment of a variety of patient conditions in ophthalmology, chronic wound care, orthopedics, and sports medicine,” said Amy Tseng, chief executive officer of  TissueTech, in a prepared statement. “We are excited that this patent represents our continued innovation and is another step forward in excelling our technological advances in the industry.”

The subsidiary Bio-Tissue, a developer of regenerative biologic therapies and ocular hygiene solutions, reportedly markets the only such technology that has been recognized by the U.S. Food & Drug Administration for optimizing wound healing while suppressing inflammation and scarring. TissueTech’s proprietary CryoTek^® preservation process is the only process that has been proven to produce an allograft that is structurally and biologically equivalent to fresh tissue, according to company officials. Visit https://tissuetech.com for more information. 

Proposed Rule Could Impact Infection Disclosures

Public disclosure of data on hospital infections in the United States could be impacted — to the point that federal health regulators will have to stop releasing information — under a proposal reportedly set to take effect in November, according to a report by USA Today. According to the report, an analysis by patient-safety advocates claims that the Centers for Medicare and Medicaid Services’ 500-page proposed rule could halt public disclosure of such infections as methicillin-resistant Staphylococcus aureus, postoperative sepsis, surgical-site infections, and accidents and injuries ranging from bedsores to respiratory failure after surgery as part of the proposed final rule. More than 600,000 hospital patients per year contract an infection, and sepsis kills about 270,000 people per year, according to the report. The proposed changes are available for public comment.

Study Shows Long-Term Success of Stem Cell Treatment for CLI 

Receiving stem cells to treat angiitis-induced critical limb ischemia (AICLI) is considered to be safe and effective, according to a long-term study published in STEM CELLS Translational Medicine, and could lead to an option for those who live with AICLI, a form of peripheral arterial disease (PAD), according to a report by AMP Central. Endovascular and surgical reconstruction are the most frequently utilized treatments for critical limb ischemia (CLI), but stem cell therapy is said to be a promising option for patients living with CLI who may not qualify for the more mainstream treatments, according to the AMP report. 

For the study, researchers tracked 27 AICLI patients for five years after each had received an intramuscular injection of purified CD34+ cell transplantation (PuCeT) to treat the disease. A promising stem cell therapy, PuCeT has shown favorable short-term results. Prior to this study, however, long-term outcomes had not been examined, according to the report. The results showed that the major-amputation-free survival rate of these patients was 88.89%, the pain-free walking time increased nearly six-fold, and the level of pain they experienced was reduced by more than half. AICLI is caused by an inflammation of the blood vessels that leads to a severe blockage in the arteries of the lower or upper extremities and causes severe pain, impaired mobility, and can lead to amputation and death. Visit www.stemcellstm.com to access the full study article. 

Colorado Company Offers Placental Donation Program

AlloSource,^® a provider of cartilage, bone, skin, soft-tissue, and cellular allografts based in Centennial, CO, is offering an ongoing placental donation program to provide the opportunity for women undergoing scheduled caesarean sections. Through the program, these patients can collaborate with their doctors to facilitate the donation of placental tissue following delivery, according to company officials. AlloSource staff members work directly with physicians, hospitals, and expectant mothers who are interested in donating tissue following an elective procedure. The process is free, confidential, and safe for mothers and their babies, officials said. The donation of amniotic tissues from the placenta can help patients in a variety of applications, such as foot and ankle procedures, spinal surgeries, and wound healing, according to officials.

“Donating tissue to help heal another person is one of the highest forms of generosity,” said Thomas Cycyota, AlloSource’s president and chief executive officer. “We are honored to work with expectant mothers and their doctors to help facilitate placental donation, which will ultimately lead to innovative therapies to help return patients to active lives.” 

FDA Taking Legal Action Against “Stem Cell Clinics”

A facility that operates as a “stem cell clinic” in South Florida is being taken to court by the U.S. Food & Drug Administration (FDA) for alleged “experimenting on patients with adulterated and misbranded drugs” and related refusals to obey the law, according to a report by CBS Miami. The U.S. Stem Cell clinic has also reportedly faced scrutiny after several patients claimed they were blinded or suffered significant vision loss following treatments at the facility, according to the report. Incidents related to the case did not involve wound care treatments. At least one procedure did involve taking stem cells from a patient’s fatty tissue, treating the stem cells, and injecting them directly into the patient’s eye to treat macular degeneration. The patient is now reportedly blind in one eye and is experiencing significant vision loss in the other eye, following a similar procedure, according to the report. Court records and a report by the New England Journal of Medicine also describe other patients and similar scenarios. Court documents also show that other parties have settled claims, according to the report.

A lawsuit filed by the FDA is reportedly seeking to have the clinic cease marketing of stem cell therapies that do not have FDA approval. “An injunction is necessary to prevent defendants from experimenting on patients with adulterated and misbranded drugs,” the suit is cited as saying. The FDA reportedly sent the facility a warning letter last year, claiming that unproven stem cell therapies need to be regulated because if cells are manipulated by a significant amount after they’re removed, there is a risk of contamination. Currently, FDA officials claim the only stem cell products that they’ve approved for use in the United States are derived from cord blood, according to the CBS Miami report.

According to the publication STAT, a news outlet that covers the field of life sciences, the U.S. Justice Department and FDA are also seeking a permanent injunction against California Stem Cell Treatment Center, another example of the reported “stem cell clinics” that have reportedly claimed that their “treatments do not fall under the category of drugs” as it relates to the alleged violating of manufacturing procedures and offering of products not evaluated or approved for patients by the FDA. The California clinic has allegedly been involved in making an experimental cancer treatment from a smallpox vaccine that is not commercially available, leading federal marshals to seize vials of the vaccine, according to a recent report by STAT, which also reported that FDA officials recently said the two clinics had failed to address agency concerns in recent months. Permanent injunctions would mandate that the halting of all stem cell treatments until manufacturing procedures are addressed, the report claims. Despite this legal action, the FDA has promoted the development of what it considers to be legitimate stem cell treatments. In November, agency officials outlined new regulatory guidelines that included a streamlined approval pathway for promising treatments in clinical trials while more clearly stipulating what standards these clinics already offering treatments need to meet, according to the report. 

Regenerative Medicine Company Licensed For Adult Stem Cell-Based Vascular Therapies 

Officials at Vascugen Inc., a regenerative medicine company based in Indianapolis, IN, that is engaged in the development of advanced medicines and transformative therapies to treat incurable vascular degenerative conditions and injuries, have announced that the company has licensed a suite of intellectual property developed at the Indiana University (IU) School of Medicine related to blood vessel formation from adult stem cells. The company is reportedly focused on finding therapies to repair tissues damaged by reduced blood flow due to disease or injury. The worldwide, exclusive licenses include patent rights to core intellectual property developed by Mervin C. Yoder, MA, MD, a company founder and distinguished professor emeritus at IU, according to company officials. The licenses broadly cover related products and services for research, diagnostics, therapeutics, tissue engineering, and 3-D printing applications arising from the technology. The Yoder lab was reportedly the first to discover rare cells that are responsible for the formation of new blood vessels in the body and to then develop methods for manufacturing those cells.

“Injuries or degenerative diseases of the vasculature affect hundreds of millions of patients worldwide,” said Yoder, who also serves as chief scientific officer of Vascugen, in a statement. “Our research seeks to understand how a healthy vasculature is maintained and propagated. I am thrilled to now advance these discoveries into clinical applications with the potential to benefit patients.”

According to the National Heart, Lung, and Blood Institute, one in 20 Americans older than age 50 lives with peripheral artery disease. More than half of patients who receive an amputation die within five years, a figure that is higher than the mortality rates for breast, colon, and prostate cancers. 

Visit www.vascugen.com for more information.