Kadimastem : Stem Cell-based Cell Therapy: The Future of Healthcare

Kadimastem: Stem Cell-based Cell Therapy: The Future of Healthcare

Revolutionizing Treatment for Any Disease with Stem Cell-based Cell Therapy

Kadimastem is a clinical stage biotechnology company in Israel involved in offering innovative cell therapies which allow large scale production of unprecedented, effective cell-based products for treating a variety of medical conditions.

Stem cells have truly revolutionized the healthcare industry. You may have heard about them in the news perhaps? Have you ever wondered whether this amazing new technology will be able to help save lives in the near future? Cell therapies, which are derived from stem cells, are one of the most widely researched and discussed topics today. Cells, created in the lab, can replace damaged cells. This opens up a wide range of applications for this technology platform in the healthcare sector. Kadimastem is one of the pioneering cell therapy companies with plans to become a global leader in cell therapy regenerative medicine.

Pioneering Stem Cell-Based Cell Therapy

Kadimastem’s cell therapy is an innovative, new frontier in medical science. Its technology is extremely beneficial in treating various degenerative diseases by restoring, replacing or repairing malfunctioning cells with normal, functional cells.

Ever since it was founded in 2009 in Nes Ziona, Israel, Kadimastem has pioneered the use of clinical grade embryonic stem cells as the starting material to create cell therapies which can help restore the function of damaged tissue. Kadimastem holds the distinction of being the only stem cell-based cell therapy company to have reached the clinical trials phase in the use of stem cell-derived committed astrocytes (neuron supporting cells) in humans. The company plans to make cell therapy affordable for all using this unique, innovative method.

Several research studies support this unique approach. Many scientists and genetic experts expect that the technology by which cell therapies can be used to generate healthy, functional tissues and organs will become more prevalent and common in the near future.

According to Dr. Michal Izrael (PhD), VP of R&D at Kadimastem, “Different cells will be used as printer ink, in combination with various biomaterials and scaffolds, allowing organs to be fully printed and tested for clinically unmet medical needs.”

Finding New Functions of Stem Cells

Pluripotent stem cells such as embryonic stem cells are the body’s raw material. These are the cells from which all other types of cells are generated. Under specific conditions, these stem cells can divide into large quantities of cells in a self-renewal expansion process. With other sets of biological signals and other conditions, these cells can also grow to become specialized cells through a differentiation process. Specialized cells are those that serve a particular function, such as skin cells, blood cells, heart muscle cells, bone cells, etc.

Kadimastem’s research is focused on finding and recapitulating the needed biological signals to “push” the naïve pluripotent stem cells toward a specialized cell type, with specific characteristics and functions. This is based on understanding the biological pathways of human embryonic development which is extremely crucial in regenerative medicine.

The difference in stem cell type resides from their stemness properties. Pluripotent stem cells, such as embryonic stem cells or induced pluripotent stem cells, are the most naïve or youngest cells that can become any cell type. Another type of stem cell is multi-potent stem cells. These exist in the adult human body and can be found in small quantities in every tissue of our bodies. These cells can become only the cells from the tissue from which they belong. For instance, mesenchymal stem cells can generate bone, cartilage or muscle. These cells continuously repair and maintain the tissue, as quality tends to decline with age. The platform technology of Kadimastem enables the generation of any cell type of our human body using the naïve pluripotent stem cells as its starting material.

Kadimastem’s Groundbreaking Cell Therapy

Kadimastem currently has two distinct cell therapy programs: one for the treatment of ALS and the second, to cure Diabetes. The first program concerns the generation and manufacturing of clinical-grade functional human Astrocytes (AstroRx®) in the company’s GMP facility. Astrocytes are the nerve supporting cells of the brain and spinal cord that help send signals to the muscles to function. The company has successfully completed Phase 1/2A clinical trials of AstroRx® cells with patients suffering from ALS, a motor neuron disease.

The results show a high safety profile of AstroRx® cells. The trial also demonstrated that this particular approach significantly decreased the progression of the disease for 3 months after AstroRx® administration, when measured by ALS Functional Rating Scale-Revised (ALSFRS-R). The company aims to test multiple injections of AstroRx® cells in the next round of clinical trials to try to prolong the beneficial effect. Kadimastem’s second product in development, IsletRx, is focused on generating, manufacturing and isolating large quantities of high performing pancreatic insulin secreting islets using clinical-grade human embryonic stem cells. The use of a specific cell surface marker combination to enrich the functional insulin secreting cell population is special only to Kadimastem.

This program aims to treat insulin-dependent diabetes, like Type-I diabetes, and to free patients from continuous monitoring of blood sugar levels and repeated insulin injections. Transplantation of IsletRx in diabetic animals restored the normoglycemic glucose level. Today, this program is in its late pre-clinical phase and is moving on the fast track to begin human trials.

Combating Challenges in Stem Cell Therapy

Talking about the various challenges that Kadimastem faced in its journey towards these cell therapies, Dr. Izrael adds, “At the beginning, we felt like pioneers developing treatments that hadn’t been defined yet, with science that hadn’t been tested, to treat diseases that we were only beginning to understand. Developing cell-based treatments for ALS and insulin dependent diabetes, like Type-I diabetes, was uncharted land. As such, we were faced with, and are still facing, new challenges. The technology is moving quickly. The regulations, however, are moving slower and will depend on how the field develops. This requires us to continuously set the highest quality bar for our products to minimize any risks.” Today, the majority of cell-based therapies are autologous, according to Dr. Izrael. Autologous techniques involve harvesting stem cells from a specific tissue of the patient to create large quantities over a period of several weeks and then transplant them into the patient. The harvested cells are taken from patients who are already manifested with the disease. In addition, the autologous approach is significantly time consuming and is often unable to create a ready-to-use stem cell therapy product, which is one of the biggest challenges overcome by Kadimastem. Expense is another challenge the company intends to overcome. Kadimastem plans to introduce off-the-shelf products to clinics at a significantly more affordable cost. The company has extensive know-how regarding cell growth, freezing techniques, scalability and cell characterization. The company is eager to collaborate with others to improve and advance the regenerative medicine field. Another key challenge in stem cell-based cell therapy is the lack of safety and efficacy in providing cell therapy to patients effectively. To ensure optimal commercialization of stem cell-based cell therapy products, it is essential to give products like AstroRx® and IsletRx, an extended shelf-life using innovative cryopreservation (freezing) techniques. Kadimastem has the ability to store large quantities of cell products for wider distribution. This ability will also help to facilitate the advanced stages of clinical and marketing trials.

Kadimastem – Leading Stem Cell-based Research Worldwide

Talking about how Kadimastem established itself as a renowned brand in cell therapy research and product development, Dr. Izrael explains, “We are big believers in strong scientific results that support the technological milestones of the company. Our focus is on demonstrating that our cell therapies first work in pre-clinical studies, then in clinical trials, while making sure the cell products are being manufactured in a state-of-the-art manufacturing facility that support our high-quality standards. We believe that this is the only way to create the value that our investors and patients expect.”