Singapore firm’s wound healing drug cleared for clinical trials by FDA

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Singapore has the second-highest proportion of diabetics among developed nations, with only the United States faring worse. 10.53 per cent of people in Singapore aged between 20 and 79 are estimated to have the chronic disease, as compared to 10.75 in US. It is also common knowledge how difficult diabetic wounds are to treat. However, a Singapore biomedical firm has received clearance from the United States Food and Drug Administration (FDA) to test its treatment on patients.

CellResearch Corporation, a Singapore-based biomedical firm has developed a treatment , using stem cells extracted from umbilical cord lining – normally discarded when a woman gives birth – that can grow into the patient’s new skin. The trials are scheduled to begin in Colorado on 30 to 100 patients early next year.

This unique treatment would put an end to the need for skin grafts. If successful, it has the potential to make CellResearch a major player in this multi-billion dollar world market that is predicted to hit US$20.4 billion by 2021. The trial is expected to last two to three years.

CellResearch used their patented stem cell technology to develop CorLiCyte. Source : Pixabay
CellResearch used their patented stem cell technology to develop CorLiCyte. Source : Pixabay

“This is a huge thing,” said CellResearch group chief medical officer Ivor Lim, pointing out that being able to produce the clinical- grade stem cells was a breakthrough that took years. Human cells are allowed for transplantation only if they are of such quality.

Founded in 2002, the firm is a pioneer and research leader in cord-lining stem cells and stem cell regenerative medicine and therapy. The three founders, Mr Tan, Dr Phan Toan Thang and Dr Ivor Lim funded the company in its early days of inception. CellResearch is now worth $700 million and has 39 patents worldwide, including those for extracting stem cells from umbilical cord lining, banking and cultivating them, and for treatments.

The company calls this drug CorLiCyte. They received the FDA clearance once they were able to successfully demonstrate that they could produce Good Manufacturing Practice (cGMP) mesenchymal stem cells at a University of Colorado laboratory.

Calecim - a skin enhancement product developed and marketed by CellResearch
Calecim – a skin enhancement product developed and marketed by CellResearch

CellResearch also markets another skin enhancement product called Calecim in Singapore, Malaysia, Taiwan, Hong Kong, Thailand and U.S.A.

Dr Toh Sue-Anne, senior consultant at the National University Hospital‘s division of endocrinology, said, “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 signalling molecules that stimulate new vessel formation and regulate inflammation. If clinical studies can build on the successes of the basic and translational research, this could revolutionise how we manage wound care in the clinic.”

Considering how serious a concern diabetes is in Singapore, the team hopes that the treatment will be available to Singapore patients within a few years. According to Dr Lim, the entire journey started with an accidental discovery when Dr Thang chanced upon the stem cell source in the umbilical cord lining – a resource that was previously untapped. Use of this resource allowed them to bypass harvesting stem cells from human embryos – a highly controversial process that destroys the embryo.

“It’s like gold mining. You get gold, but 40 per cent is rock and sand and other impurities you don’t want,” said Dr Phan. “But we have found a gold mine that’s 99 per cent gold.”

Singapore has a come a long way in building a vibrant research and development (R&D) landscape for the biomedical sector. In the last 15 years, it has successfully grown the nation’s biomedical industry by attracting the world’s leading biomedical companies and researchers into Singapore. This has led to an increase in public-private partnerships where multinational pharmaceutical and biotechnology companies and local institutions have partnered in ground-breaking R&D projects. However, this success comes at a time when labs are struggling to take stem cell research to market, as there are many regulatory hurdles before treatments can be proven safe and effective.

“It paves the way for future clinical trials as we don’t need to go through as many regulatory roadblocks,” said Associate Professor Lim Kah Leong of the National Neuroscience Institute and National University of Singapore’s Yong Loo Lin School of Medicine. “You can also apply it to human patients without concern that there could be contamination issues.”

“We were just trying to get enough cells in an inexpensive way for skin repair – that was our first intention,” said Dr Phan. “Then we discovered that a lot more can be done beyond skin needs.”

CellResearch is now working with other groups to utilize stem cells for treatment of a range of conditions – from Parkinson’s to hearing loss to heart repair.