“Stem cell therapy” and “regenerative medicine” are often thought to be synonymous, but they’re not quite the same thing. Yes, stem cells are the stuff of bone marrow transplantation, and they have shown promise in retarding degenerative diseases. Nonetheless, they have yet to be incorporated into widely deployed tissue regeneration applications in the clinic. Fortunately, tissue regeneration needn’t wait for infusions of harvested or reprogrammed stem cells. Instead, it can get started with tissue matrices that serve as frameworks for healing.
Tissue matrix technology is the specialty of the aptly named TissueTech, a leader in developing products derived from human birth tissues. In fact, a TissueTech subsidiary named Amniox Medical processes cryopreserved umbilical cord and amniotic membrane for the treatment of acute and chronic wounds.
Amniox recently completed a Phase II pilot trial of TTAX01 cryopreserved human umbilical cord for use in complex, nonhealing diabetic foot ulcers (DFUs). Currently, DFUs have yet to be specifically targeted by any FDA-approved therapies, and many DFUs lead to complications that result in amputations. DFUs, however, could be resolved by TTAX01. In fact, the TTAX01 trial’s results suggest that amputations resulting from DFUs could be reduced dramatically within the next few years.
In the TTAX01 trial, which yielded results in May, half the patients with Wagner Grade 3 and 4 DFUs (those with wounds extending to the muscle, fascia, or bone) and half of those with biopsy-confirmed osteomyelitis healed completely within 16 weeks after treatment, which involved applying Amniox’ cord tissue product to the surface of the wound. An ongoing follow-up study shows that 83% of participants’ foot ulcers have closed to date.
TissueTech is advancing TTAX01 into Phase III testing. The company is also working to apply its technology to heal other kinds of wounds and to advance pain management.
Living cells not included
The TTAX01 trial results and findings from TissueTech’s other studies reinforce the company’s belief that regenerative therapies needn’t involve stem cells or plasma-rich platelet transplantations. “Our umbilical cord and amniotic membrane birth tissue products differ from other regenerative therapies in that they don’t contain living cells,” says Amy Tseng, president, CEO, and co-founder of TissueTech. “They create a healing environment that allows patients’ own stem cells to repair and regenerate after injury.”
Offering a case in point, Tseng notes, “Bio-Tissue, another commercial subsidiary of TissueTech, provides amniotic membrane–based birth tissue products to help ophthalmologists and optometrists treat ocular surface diseases and injuries, either in a surgical facility or a physician’s clinic.”
One of the benefits of Amniox’ regenerative technology is that the products retain the fetal anti-inflammatory and antiscarring modes of action, which improve clinical outcomes. Perhaps more important, they are immunoprivileged. Consequently, unlike organ or tissue transplants, they don’t risk rejection by the immune system.
“Think about birth tissue,” she suggests. “It is the only tissue designed by nature that is specifically used to facilitate fetal development. As shown by the relationship between a pregnant woman and her fetus, the birth tissue provides an immunoprivileged barrier between the mother’s immune system and the developing child. Without this barrier, the mother’s body might reject the baby as a foreign body.”
Tseng’s point seems obvious, yet birth tissue products still represent an emerging area of regenerative therapies. Consequently, increasing the adoption rate among physicians can be challenging.
“Peer-to-peer education and training is vital to increase the understanding and adoption of our new technologies,” Tseng insists. “We’re introducing a new concept—one that many physicians and surgeons haven’t necessarily experienced during medical school or residency training. Thus, peer-to-peer education and hands-on training is a priority for Amniox.”
A shift to biologic therapies
In 2011, when Amniox was founded, TissueTech emphasized tissue-based manufacturing. At present, however, TissueTech recognizes “the value of conducting the clinical trials necessary to apply for biologics licenses from the FDA and to gain approvals for disease-specific indications for our products,” Tseng says. The continuous research and innovation needed to gain these approvals will further expand TissueTech’s prospects.
To maximize its opportunities, TissueTech is shifting from tissue-based manufacturing to the provision of biologic therapies. Tseng presents this as a natural step in the company’s growth based on its scientific and clinical achievements: “We see [the transformation] as a tremendous opportunity to add to the library of proof we have for our products, to increase their value for physicians, and to illustrate their efficacy and safety to patients. We are, therefore, committed to becoming the first birth tissue biologics therapy provider for many of the conditions our products can treat.”
One of the most recent steps in the company’s growth is its migration to a cloud-based clinical platform. The benefits of the move include improved efficiency and the creation of a “single source of truth” from which to manage clinical studies.
Eyes on the future
Looking forward, Tseng sees opportunities for introducing human birth tissue products to medical specialists such as orthopedic surgeons, podiatrists, urologists, plastic surgeons, and gynecologists. Potential applications include wound healing, pain management, and sports medicine.
“Starting out and, really, even today, we sometimes struggle with where to target our efforts,” Tseng says. “Ultimately, we must focus on indications where we can best improve outcomes and facilitate the treatment of unmet needs.”
Spina bifida is one of those target areas. Referring to preliminary clinical successes in treating spina bifida, Tseng declares, “It excites me to be able to change a baby’s and family’s life.”
“We’re extremely focused on our tranformation from a birth tissue manufacturer to a biologics provider,” she continues. If TissueTech’s clinical work continues advancing toward commercialization as expected, regenerative therapy will have another technology in its armamentarium—one that promises not only to heal wounds, but also to prevent many amputations.
Location: 7300 Corporate Center Drive, Suite 700, Miami, FL 33126
Principal: Amy Tseng, President, CEO, and co-founder
Number of Employees: 267
Focus: TissueTech develops birth tissue–based products for varied ocular, surgical, and wound care applications.