HONG KONG – Singapore is becoming a hotbed for stem cell research. And a recent breakthrough involving a stem cell treatment for diabetic wounds, developed by Cellresearch Corp. Pte. Ltd., could further cement the nation’s reputation as a leader in biomedical innovation.
Diabetic wounds are known to be difficult to treat. As Singapore has the second highest prevalence rate of diabetes among developed countries, following the U.S., the nation’s medical firms have been racing to provide a solution. An estimated 10.53 percent of people in Singapore between the ages of 20 and 79 have diabetes, compared to 10.75 percent in the U.S. A successful treatment would mean lucrative business in the market.
“Wound healing is a big market, especially because of diabetics,” said Por Yong Chen, vice chairman of the Chapter of Plastic, Reconstructive & Aesthetic Surgeons.
Cellresearch has developed a treatment using stem cells extracted from umbilical cord lining, which is normally thrown away after a woman gives birth, to grow into the patient’s new skin. The firm has received clinical trial clearance from the FDA. Trials are scheduled to begin in Colorado on 30 to 100 patients early next year, and are expected to last two to three years.
The company hopes the treatment will be available in Singapore within a few years.
“This is a significant breakthrough. I think a lot of people are going to try to do the same thing,” said Por.
Producing the clinical-grade stem cells was a breakthrough that took years, said Ivor Lim, founding director of Cellresearch. Transplantation using human cells is allowed only if the cells are of that quality.
The cells from the umbilical cord lining can create new skin and bone, and even other body parts, such as the cornea in the eye.
The new product is called Corlicyte. It received FDA clearance after Cellresearch successfully produced cGMP mesenchymal stem cells at a laboratory at the University of Colorado.
The treatment, if successful, would provide a unique alternative to skin grafts, while Cellresearch would be on track to become a major player in wound care treatment, a multibillion-dollar global market that is forecast to reach $20.4 billion by 2021, according to research and consulting firm Marketsandmarkets.
“Stem cells from cord lining offer a promising approach to wound therapy in patients with diabetes, because they release growth factors and cytokines and cell signaling molecules that stimulate new vessel formation and regulate inflammation,” said Toh Sue-Anne, senior consultant at the National University Hospital’s division of endocrinology. “If clinical studies can build on the successes of the basic and translational research, this could revolutionize how we manage wound care in the clinic.”
In the past decade, Singapore has attracted world-leading biomedical companies and researchers, and has seen an increase in domestic firms expanding successfully in the medical sector. That has established a vibrant and fertile landscape for medical R&D, which has grown the nation’s biomedical industry. Multinational pharmaceutical and biotech companies are increasingly collaborating with local institutions on innovative projects. Those public-private partnerships have paved the path for the technologically advanced nation to become a leading biomedical R&D hub.
“I think Singapore in the last few years has been a hub for medical R&D because of its financial strengths, its capabilities and its international platforms,” said Sigal Atzmon, president of Medix Group, a global health care consultancy and medical service provider.
However, there are many regulatory hurdles before stem cell treatments are allowed to market. For Cellresearch, the road may still be long before its product is proved safe and effective.
“[There are] many challenges in moving forward to perfect a product, and to make it inexpensive enough for everyone to use,” said Phan Toan Thang, founding director and group chief scientific officer of Cellresearch.
“Bringing stem cell therapy research from lab to bedside and market faces many challenges ranging from ethical and religious controversial, health care regulation, high standard biomanufacturing to patient affordability or insurance reimbursement.”
Founded in 2002, Cellresearch is a research leader in cord-lining stem cells and stem cell regenerative medicine and therapy. Now worth about $700 million, the firm has 39 patents worldwide, including those for extracting stem cells from umbilical cord lining, banking and cultivating them and using them for treatments.
The company also markets a skin enhancement product called Calecim in Singapore, Taiwan, Hong Kong, Malaysia, Thailand and the U.S.
Beyond wound healing, Cellresearch is conducting research on the use of stem cells for treatment other conditions, including Parkinson’s disease, hearing loss and heart conditions.