Stem Cell Clinic

The untapped market of cord blood banking – The Malaysian Reserve

The untapped market of cord blood banking Thursday, October 15th, 2020 at , Life & Art

Stem cell therapy could be one of the complementary treatments to alleviate sufferings in Covid-19 patients

By AZALEA AZUAR

Wong says his team aims to do their part in raising awareness about the importance of stem cell banking in Malaysia

ACCORDING to a recent study and clinical trial in China, mesenchymal stem cell (MSC) therapy has been shown to alleviate pneumonia and acute respiratory syndrome (ARDS) symptoms through their immunomodulatory activities in Covid-19 patients.

Although more research studies and clinical trial results are needed to demonstrate the use of stem cells in providing relief to Covid-19 patients, the findings have been rather encouraging.

Patients treated with MSCs have somehow regained lung functions and have restored levels of cytokines and trophic factors.

In short, stem cell therapy could be one of the complementary treatments to alleviate sufferings in Covid-19 patients.

While stem cell therapy has been used in different health procedures for various ailments, the rise in the number of Covid-19 patients worldwide is an indication that the potential for companies that promote such treatment is certainly huge.

However, the stem cell banking industry in Malaysia has not been exploited yet as in-depth information about cord blood banking applications and clinical trials is still not widely available to the public.

StemLife Bhd CEO Raymond Wong said there are advertisements about stem cell therapies and supplements that are unproven, which left the public somewhat misinformed.

A study conducted by nurses in Malaysia discovered that 92% of respondents only had moderate knowledge of the technology. In another study, 80% of respondents said their healthcare providers were unable to provide sufficient information regarding stem cells, while 94% wanted their healthcare provider to share the information, he told The Malaysian Reserve in an interview.

Wong said his team aims to do their part in raising awareness about the importance of stem cell banking in Malaysia.

It is a form of insurance for families. Our team sees it as one of the best healthcare investment options because the list of cell-based therapy applications is growing throughout the year and there have been many recent research and medical advances in regard to stem cell therapy, he said.

Wong said banking stem cells would be a long-term investment that families and individuals could live healthier, longer and happier.

At the same time, he said the technology also serves as a sustainable medical solution that is readily available.

For the uninitiated, a stem cell has the unique ability to develop into specialised cell types in the body. In the future, they may be used to replace cells and tissues that have been damaged or lost due to different diseases.

By 2025, the world stem cell market is projected to reach more than US$12.5 billion (RM51.88 billion).

The US is expected to maintain a 9.7% growth momentum, while Germany will bring some US$294.1 million to Europe in the next five to six years.

In Asia, Japans stem cell industry will reach a market size of US$899.5 million and it has the potential to grow at 8.1% over the next couple of years.

Wong said cord blood banking is another service under the stem cell market, where the blood from the umbilical cord is extracted during birth to treat more than 80 genetic diseases since it contains a rich source of stem cells.

One small amount of cord blood is collected and can be stored for future use.

By 2023, the Asia-Pacific region is expected to dominate the global cord banking services market in terms of growth rate.

The region is also expected to show a huge growth potential due to the increasing awareness of stem cell banking, as well as vast improvements in healthcare reforms in countries like Indonesia, India, Malaysia and China, although it currently has a minimal share in the global market.

Such a bright outlook in the region also grants better opportunities for companies that offer such solution to grow in a huge and untapped regional market which is currently trailing behind regions like North America and Europe.

The Younger, The Better

The procedure of collecting cord blood and umbilical cord does not harm the baby or the mother

Wong said previously, bone marrow and umbilical cord were popular sources to extract stem cells, but with the advancement in stem cell therapy, researchers have successfully extracted stem cells from other sources too.

The younger the stem cells, the better the regenerative properties. The youngest source of stem cells that we can extract from the human body is from the umbilical cord.

On top of that, the umbilical cord is also the richest source of stem cells with over 20 million cells per cu cm, Wong said.

He said stem cell extraction from the bone marrow is seen more as an invasive procedure, which always carries the risk of complications as it could also result in permanent damage to the site of extraction.

On the contrary, the procedure of collecting cord blood and umbilical cord does not harm the baby or the mother.

In fact, our standard operation of procedure places the highest priority on the safety of the mother and the baby before any collection can be done, he said.

Wong said studies have also proven that transplantation of stem cells from umbilical cord carries lower risk of developing graft versus host complication, as the stem cells in the umbilical cord arent fully developed.

Therefore, he said, the human leukocyte antigen matching of stem cells to the patient is less stringent compared to stem cells from other sources.

Specific Stem Cells

Successes in the clinical application of stem cells serve as graphic illustrations of how it can be translated into useful therapies

Just as there are many ways to extract stem cells, there are also different types of stem cells used to treat different diseases.

One of them is blood-forming cells which can develop into all types of blood cells.

This unique property allows the blood-forming stem cells to be successfully used to treat various blood disorders and blood malignancies like leukaemia and thalassemia, Wong said.

However, he said stem cells are not only limited for blood-related illness treatment as they can also treat other disorders, such as immunodeficiency disorders and certain types of metabolic disorders.

To date, there are about 80 diseases that are recognised by Malaysias Ministry of Health (MoH) as standard care of treatment using blood-forming stem cell therapy.

Moreover, the discovery of tissue- forming stem cells has led to growing interest in the use of these cells as therapeutics, Wong said.

He added that researches about stem cells are now venturing into preclinical and clinical studies to resolve injuries by enhancing endogenous repair programmes.

He said there are also tissue-forming cells which have been widely tested in clinical trials of cardiovascular, neurological and immunological diseases with encouraging results.

Pioneering studies that led to successful culturing of human epithelial stem cells opened the door for subsequent clinical applications of epithelial stem cells in regenerative medicine, Wong added.

Such treatments were first applied during the 1980s to treat patients who suffered from burns. Now, it saves the lives of those who have been severely burnt.

Furthermore, developing applications to generate corneal cells for treating certain forms of blindness has garnered the focus of clinical researchers.

More recently, cases of eye damage have been successfully treated by transplanting the corneal epithelial sheets cultured from epithelial stem cells.

Wong added that successes in the clinical application of stem cells serve as graphic illustrations of how exciting advances in the laboratory can be translated into useful therapies.

It encourages the development of other stem cell applications in the regenerative medicine field.

Things to Consider

One can choose to go to either the public or cord blood banking facilities. The public cord blood banking facilities are within the purview of the National Blood Bank which is parked under the MoH, where any mothers can make their donations.

The public also have a choice to do non-directed donations, directed donations (among at-risk families) and directed donations (for low-risk families).

Wong said while private banking is a good choice, many families are concerned that they have to pay a high price for such peace of mind.

In terms of affordability, the costs at private cord blood banks are not as high as some might think. For example, at StemLife, the cost to store cord blood roughly translates to about only 80 sen a day.

In comparison, that is more affordable than your daily morning coffee or tea at a coffee shop or kopitiam, he said.

StemLife also encourages parents to consult their healthcare providers on the benefits of storing in private banks, especially if a family member has a high risk of developing or have been diagnosed with diseases that are treatable with stem cell therapy.

This would ensure the sufficiency of stem cells for future treatments.

Secondly, with the advancement of clinical research in regenerative medicine, its worth considering its future usage.

For example, umbilical cord blood-derived MSCs have proven to be beneficial, exhibiting therapeutic effects in Covid-19 patients with cytokine storm and ARDS, Wong said.

Going Digital

Last year, more than 60,000 mothers registered with StemLife. However, due to the Covid-19 pandemic, StemLifes business suffered just like any other private healthcare providers in the first half of the year.

This is mainly due to limited outreach to the expectant parents from our customer-facing channels during the pandemic and the safety measures taken by the government, Wong said.

Nevertheless, the number of donors has been picking up steadily under the Recovery Movement Control Order, and StemLife is now keeping a more positive outlook.

Wong said digital engagements would help the company further interact with other potential donors.

The most significant changes will be in the way we introduce our services how we engage with our customers and our utilisation of customer data. These changes will lead to much greater levels of personalisation, Wong said.

Currently, StemLife is looking at adopting the digital-first advice approach among their team members, by engaging customers via video call from the comfort of their homes.

Secondly, we are looking to create a seamless customer purchase process through digitalisation. Thirdly, we aim to keep track of our customers data, while maintaining a high level of privacy to personalise customer experience, Wong commented.

They aim to monitor the three phases of motherhood which is conceiving, expecting and parenthood.

This is to ensure the mothers receive the help they need as they go through the many phases of their journey with their babies.

Secondly, we will be embarking on a digital rebranding exercise to strengthen our competitive position and energising our teams internally. In addition, we will also be ensuring that our remote workplace set-ups are smooth by using collaboration tools embedding these solutions into our operating model and roadmaps, Wong said.

StemLife is also planning to introduce genomic screening tests that can help detect disease risks of newborns through strategic partnerships.

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The untapped market of cord blood banking - The Malaysian Reserve

Singapore invents digitized optimization of culture conditions for cell therapy – BSA bureau

Collaboration by researchers in Singapore and Australia leads to first-of-its-kind computational biology algorithm that could enable more effective cellular therapies against major diseases.

Cellular therapy is a powerful strategy to produce patient-specific, personalized cells to treat many diseases, including heart disease and neurological disorders. But a major challenge for cell therapy applications is keeping cells alive and well in the lab.

Researchers at Duke-NUS Medical School, Singapore, and Monash University, Australia, have devised an algorithm that can predict what molecules are needed to keep cells healthy in laboratory cultures. They developed a computational approach called EpiMogrify, that can predict the molecules needed to signal stem cells to change into specific tissue cells, which can help accelerate treatments that require growing patient cells in the lab.

Computational biology is rapidly becoming a key enabler in cell therapy, providing a way to short-circuit otherwise expensive and time-consuming discovery approaches with cleverly designed algorithms, said Assistant Professor Owen Rackham, a computational biologist at Duke-NUS, and a senior and corresponding author of the study, published today in the journal Cell Systems.

In the laboratory, cells are often grown and maintained in cell cultures, formed of a substance, called a medium, which contains nutrients and other molecules. It has been an ongoing challenge to identify the necessary molecules to maintain high-quality cells in culture, as well as finding molecules that can induce stem cells to convert to other cell types.

The research team developed a computer model called EpiMogrify that successfully identified molecules to add to cell culture media to maintain healthy nerve cells, called astrocytes, and heart cells, called cardiomyocytes. They also used their model to successfully predict molecules that trigger stem cells to turn into astrocytes and cardiomyocytes.

Research at Duke-NUS is paving the road for cell therapies and regenerative medicine to enter the clinic in Singapore and worldwide; this study leverages our expertise in computational and systems biology to facilitate the good manufacturing practice (GMP) production of high-quality cells for these much needed therapeutic applications, said Associate Professor Enrico Petretto, who leads the Systems Genetics group at Duke-NUS, and is a senior and corresponding author of the study.

The researchers added existing information into their model about genes tagged with epigenetic markers whose presence indicates that a gene is important for cell identity. The model then determines which of these genes actually code for proteins necessary for a cells identity.

Additionally, the model incorporates data about proteins that bind to cell receptors to influencetheir activities. Together, this information is used by the computer model to predict specific proteins that will influence different cells identities.

This approach facilitates the identification of the optimum cell culture conditions for converting cells and also for growing the high-quality cells required for cell therapy applications, said ARC Future Fellow Professor Jose Polo, from Monash Universitys Biomedicine Discovery Institute and the Australian Research Medicine Institute, who is also a senior and corresponding author of the study.

The team compared cultures using protein molecules predicted by EpiMogrify to a type of commonly used cell culture that uses a large amount of unknown or undefined complex molecules and chemicals. They found the EpiMogrify-predicted cultures worked as well or even surpassed their effectiveness.

The researchers have filed for a patent on their computational approach and the cell culture factors it predicted for maintaining and controlling cell fate. EpiMogrifys predicted molecules are available for other researchers to explore on a public database: http://epimogrify.ddnetbio.com.

The developed technology can identify cell culture conditions required to manipulate cell fate and this facilitates growing important cells in chemically-defined cultures for cell therapy applications, added Dr Uma S. Kamaraj, lead author of the study and a graduate of Duke-NUS Integrated Biology and Medicine PhD Programme.

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Singapore invents digitized optimization of culture conditions for cell therapy - BSA bureau

Pluristem Announces Clearance to Move Forward with Enrollment for Cohort II in an Investigator-Led Phase I/II Chronic Graft vs Host Disease…

HAIFA, Israel, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that it has received clearance from the safety committee of an investigator initiated Phase I/II study to move forward with patient enrollment for cohort II. The study will evaluate PLX-PAD cells in the treatment of steroid-refractory chronic graft vs. host disease (GvHD) and is led by Principal Investigator Prof. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit at Tel Aviv Sourasky Medical Center, Ichilov Hospital, Israel. Prof. Ram and his research staff are responsible for the design and implementation of the study at Sourasky Medical Center.

GvHD is a severe complication in patients who have undergone an allogeneic hematopoietic cell transplantation (HCT) and is a major cause of morbidity and mortality in these patients in which the donated stem cells identify the recipient's body as foreign and attack it. The chronic form of GvHD (cGvHD) usually appears later than 100 days post-transplant.

Cohort I included 6 patients treated with 2 injections of 150 million cells, a week apart. At the 3-month follow up, interim safety results concluded that PLX-PAD cells were safe and that no treatment related side effects were reported. Efficacy results demonstrated that 4 out of the 6 patients reported improvement in symptoms that translated into a reduction in the severity of cGvHD with notable reduction in the required steroid doses for part of the patients. Based on these results, the study was approved to commence enrollment of 14 patients in cohort II to be treated with 4 injections of 150 million cells.

Prof. Ram of Ichilov Hospital commented, From our experience in having treated 6 patients in the study to date, we have so far found no negative side effects from the use of the PLX-PAD cells in the treatment of steroid-refractory cGvHD. Patients with significant GvHD skin disorders previously unresponsive to multiple types of therapy showed remarkable response. Responses were also observed for severe mouth ulcers which prevented patients from eating solid foods. This resulted in a major improvement of quality of life and tapering of steroid doses."

Pluristem is committed to contributing to the wellbeing and quality of life of our patients. cGvHD is an indication where we see a significant need to enhance the current course of treatment for this life-threatening condition among patients undergoing bone marrow transplants. The preliminary results from cohort I of this Phase I/II study, and prior preclinical data, both indicate that PLX-PAD cells may potentially treat cGvHD patients and mitigate symptoms. We are very pleased to cooperate with Prof. Ram and Sourasky Medical Center, and we place a high importance in examining PLX-PAD for this indication, stated Pluristem CEO and President, Yaky Yanay.

About cGvHD Chronic graft-versus-host disease (cGvHD) remains a common and potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (HCT). The 2-year cumulative incidence of chronic GvHD requiring systemic treatment is 30% to 40% by National Institutes of Health criteria1. The hematopoietic stem cell transplants are used to treat bone marrow failure resulting from treatment of some blood or bone marrow cancers as well as other hematologic failures, such as aplastic anemia, which are not related to cancer. The donated cells identify the recipients body as foreign and attack it as a result. While acute GvHD usually appears in the first 100 days after a transplant, and in specific body systems, chronic GvHD can occur at any time (even several years) after a transplant, and may manifest in many parts of the body such as: skin, mouth, eyes, liver, intestines, lungs and joints. Long term immunosuppression is given to try to prevent or treat cGvHD. Since this treatment suppresses the immune system for a very long time, patients are at high risk of infections, and are prescribed multiple medications to try to address this major risk.

About Pluristem Therapeutics Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the patient enrollment for cohort II for its Phase I/II study of its PLX-PAD cells, the implication from the results of the first patient cohort in the study, the belief that GvHD is an indication that has a significant need for enhanced treatments among patients undergoing bone marrow transplants and that the preliminary results from cohort I of the study, and the prior preclinical data, indicate that PLX-PAD cells may potentially treat chronic GvHD patients and mitigate symptoms. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana Rubin Director of Investor Relations 972-74-7107194 danar@pluristem.com

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1 Flowers ME, Martin PJ. How we treat chronic graft-versus-host disease. Blood. 2015 Jan 22;125(4):606-15. doi: 10.1182/blood-2014-08-551994. Epub 2014 Nov 14. PMID: 25398933; PMCID: PMC4304105., https://pubmed.ncbi.nlm.nih.gov/25398933/

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Pluristem Announces Clearance to Move Forward with Enrollment for Cohort II in an Investigator-Led Phase I/II Chronic Graft vs Host Disease...