
Malaysian firm achieves breakthrough in stem cell therapy
According to Cytopeutics Sdn Bhd chief executive officer Prof Dr Chin Sze Piaw, the company is the first and only one in the country to obtain the Clinical Trial Exemption (CTX) licence for mesenchymal stem cells (MSC) for clinical use, issued by the Ministry of Health (MoH).
In a recent programme undertaken at five MoH hospitals, one university hospital and one private hospital, they had been treating patients with cancer, specifically leukaemia, who underwent organ transplants but subsequently experienced recipient rejection.
One particular child patient had graft-versus-host disease (GVHD), which occurs when the donor tissue reacts against the recipient's body. The child's body was breaking down, and he was bleeding from his nose, mouth, and under his skin.
Dr Chin said the chances of survival in such cases are practically zero, as doctors would usually administer steroids, allowing the patients to survive for about three months before succumbing to cancer or infection.
'But our stem cells could overcome this. They come in like a mediator between the body and the transplant, and say, 'Hey, let's stop fighting and help each other.'
'And with our stem cells, it showed 100 percent survival for the patient within a year. Without the treatment, it was zero percent.
'MSC not only does not cause any cross-reactivity, it is actually used to treat such conditions,' he said at a special talk at a hotel here recently, organised by Maden Global Consultation (MGC) and Sunway MediSpa.
Malaysia is one of six countries in the world that have approved the use of MSC for GVHD, and Cytopeutics is one of four companies to have received this approval.
Dr Chin said they are also using stem cells to treat other significant diseases such as stroke, heart failure, diabetes, pre-diabetes and diabetes complications, autoimmune diseases like psoriasis, macular degeneration (blindness), and cancer.
Among the treatments were cases involving patients on heart transplant waiting lists, where they demonstrated how they could eliminate scar tissue and create entirely new heart muscle for the patients.
Aside from being the only Malaysian company that can manufacture stem cells for human clinical use safely, they are also the only one in the world to have ever received halal endorsement for the product.
Cytopeutics has been working with the Department of Islamic Development (Jakim) since 2014 and has demonstrated for eight years that they are shariah-compliant, but they wanted to obtain the halal stamp.
To do this, they had to show that their stem cells are produced in a halal manner.
'There are strict criteria to adhere to in the process of getting halal endorsement.
'The product has to be not just medically safe, but socially responsible and acceptable by all religions,' he explained.
To this end, Dr Chin stressed to the public that not only are stem cells extracted from animals not halal, but they are also unsafe.
Most people opt for animal-based stem cells because they are usually cheaper than safer alternatives.
To get cheaper stem cells, the cells are grown using commercially available nutritional medium or animal serum/blood.
Notably, animal stem cell therapy has been banned in almost all countries around the world.
'So, a lot of people would use blood or serum from cows or horses. This is not safe because the serum contains many viruses and antibodies,' he said.
One way to assess the safety of stem cells is to ask the laboratory how they process their stem cells.
If they refuse to answer, Dr Chin advised walking away.
'If you're injecting something into your body and it sounds too good to be true, it probably is,' he said.
Cytopeutics uses MSCs for many of their treatments, which are approved by the regulatory bodies of the United States and China.
MSC is akin to the O-negative red blood cell, which can be universally accepted by all blood types.
The company started exploring stem cells obtained from umbilical cords about 26 years ago, despite being mocked as the structure is typically discarded.
Twenty years later, it has proved to be one of the safest sources of stem cells for treatment.
Dr Chin shared about a study involving three generations of families treated using MSCs, who underwent regular health checks.
The infants' genes and chromosomes were inspected through full genomic sequencing, where each chromosome was unraveled to see how the genetic codes are arranged.
The results of the study were very positive.
'We were the first and still the only ones to have completed a phase one human study on this, where we followed up with everybody for a minimum of five years.
'Now we are at 15 years, and throughout this time, nobody in the study has had heart attacks, diabetes, new infections or viruses, or cancer,' said Dr Chin.
Also present were Universiti Malaysia Sabah (UMS) senior lecturer Dr Suhaini Sudi, UMS Faculty of Science and Natural Resources head of programme Dr Lucky Goh Poh Wah, Datuk Eliza Goh, MGC managing director Dona Chuan, MGC chief executive officer Alister Yong, and Sunway MediSpa general manager Dr Daniel Rejith.
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