Introduction

Kidney & Organ Regeneration

Introduction

Worldwide challenge in 2030: 14.5 million patients needing dialysis or transplantation for kidney failure

Recently, in South Korea, there has been an increased focus on the institutional efforts related to the staffing, facilities, and equipment operation of artificial kidney dialysis centers. In particular, on September 3rd, the Korean Dialysis Association hosted a symposium and emphasized the need for specialized management of the medical environment for dialysis patients. This emphasis is due to the significant increase in the number of domestic blood dialysis patients, highlighting the growing importance of their dialysis environment. Especially the number of patients undergoing hemodialysis, increased 1.8 times from 50,896 in 2009 to 104,157 in 2021 over a 22-year period.

Source: Doctors News, http://www.doctorsnews.co.kr

The number of patients with kidney disease is not only escalated in South Korea, but this has also become an attention from a global perspective. Currently, 2.6 million individuals are undergoing dialysis or trans- plantation for kidney failure, and it’s expected that this figure will double to 5.4 million by 2030.

Worldwide challenge in 2030

The annual costs of dialysis and kidney transplantation(KT)are between $35,000 to $100,000 per patient

Source: Schiffrin EL, Lipman ML, Mann JF. Chronic kidney disease: Effects on the cardiovascular system. Circulation 2007;116(1):85–97.

The US Centers for Disease Control and Prevention (CDC) anticipates that 47% of individuals aged 30 and older will experience chronic kidney disease (CKD) at some point in their lives. For the 11% of those with stage 3 CKD, inadequate treatment frequently leads to the progression of CKD to end-stage renal disease (ESRD)

Despite the substantial increase in the number of CKD patients and the expectation of further growth, there remains a limited range of treatment options available to them. Kidney failure can be managed through hemodialysis, peritoneal dialysis, or kidney transplantation. Hemodialysis, often referred to as the artificial kidney, can be administered either in a dialysis unit or in the patient’s own home, typically requiring three weekly sessions. On the other hand, peritoneal dialysis is typically conducted on a daily basis and is usually carried out at home. Kidney patients need to allocate their own time to undergo dialysis several times a week, but the cost associated with managing this is also substantial.

Although the number of patients going through dialysis systems are increasing, the expenses associated the treatment remains expensive. The expenses associated with dialysis and kidney transplantation (KT) alone are projected to fall within the range of $35,000 to $100,000 per patient. This financial burden is beyond the means of many governments in various regions across the globe.

Source: Source: Global perspective of kidney diseases: Challenges and changes (Masaonmi Nangaku, August 2023) https://doi.org/10.1111/nep.14200 https://onlinelibrary.wiley.com/doi/full/10.1111/nep.14200l

Furthermore, in the context of a decreasing number of doctors, effective treatments and medical care may become challenging in the future. One over four of most countries indicated a deficiency in nephrologists (86%) and vascular access coordinators (81%). This means 21% of countries lack professional doctors.

Kidney Regeneration

Treatments for patients with chronic kidney diseases

To effectively handle your chronic kidney disease (CKD), it might be necessary to make adjustments to your dietary choices. Collaborate with a licensed dietitian to create a meal strategy that incorporates foods you find enjoyable while safeguarding your kidney’s well-being.

What are some of guidelines to assist you in making appropriate dietary choices while managing your kidney condition?

Kidney Regeneration

Revolutionary treatment for kidney chronic disease

Globally, there has been lack of treatments available for patients to consider, but there are high number of patients with chronic kidney diseases. Moreover, the treatments such as dialysis are very expensive for patients to continuously receive. Therefore treatments with relatively reasonable price are required in the market.

ROKIT HEALTHCARE presents a game-changing solution for dialysis patients awaiting kidney transplants. Their kidney regeneration platform involves transplanting a 3D bio-printed omentum patch onto damaged kidneys, potentially reducing the need for ongoing dialysis.

The procedure is swift, taking just an hour in an operating room. It begins with a physician extracting fat from the patient, processed into bioink. Simultaneously, patient data and medical records are saved in an AI app, which generates specific printing instructions based on this information.

Unique to ROKIT is the integration of AI technology. The AI system learns from CKD patient data, including ultrasound, baseline characteristics, blood analysis, and urinalysis, optimizing the patch for each patient. All these steps occur within a sterile surgical environment and can be completed in 1 to 2 hours.

The 3D bio-printer, empowered by AI, streamlines patch production with a simple “Printing” command, ensuring consistent results without relying on manual skills. This innovation holds great promise for CKD patients currently on dialysis, offering a potentially transformative alternative.

Kidney Regneration

Regeneration potential of omentum bio-printing patch by self-stem and progenitor cell-led tissue recovery

Kidney damage poses significant challenges to our health, but the human body possesses remarkable innate mechanisms for repair and regeneration. After kidney injury, the local environment undergoes dynamic changes, creating an intricate interplay of factors that promote tissue recovery.

The Dynamic Microenvironment on a Damaged Kidney:

When there’s damage on a kidney, the local microenvironment transforms into a complex milieu characterized by inflammation, oxygen deficiency (hypoxia), and immune system activation. These changes play pivotal roles in orchestrating the recruitment, differentiation, and activation of stem and progenitor cells to kidney, as well as the release of angiogenesis factors, which are crucial for tissue repair.

Self-Renewal Mechanisms of Autologous Kidney Patch:

Stem and progenitor cells possess remarkable regenerative potential. To empower these innate self-renewal mechanisms, ROKIT HEALTHCARE has developed an autologous tissue-derived treatment patch that can be attached to damaged kidneys. The patch enhances the microenvironment, creating an environment conducive to tissue regeneration.

ⅡThe Patch’s Healing Potentials:

Upon analysis of the treatment patch’s composition, it was revealed that it contains a multitude of growth factors known to support kidney regeneration. Additionally, it sends cytokines that promote the recruitment of stem cells to the site of injury on a kidney. This combined actions create a regenerative microenvironment in the damaged kidney.

Ⅱ Facilitating Tissue Recovery:

Incorporating these treatment patches into our approach generates a synergistic effect, resulting in self-stem and progenitor cell-led tissue recovery. By working in harmony with the body’s natural healing processes, the patches promote angiogenesis, curb inflammation, and suppress immune responses—essential factors for efficient kidney regeneration.

Kidney Regeneration

Proven regenerative stability and capability through clinical trials

Efficacy evaluation after patch treatment

In our preclinical study utilizing a CKD rat model, we observed a reduction in tubular injury within the group treated with the omentum patch. Furthermore, the omentum patch had a notable impact on the biological processes related to gene ontology, particularly genes associated with fibrosis and growth factors. The antifibrotic effect was corroborated through RNA sequencing, which demonstrated the inhibition of fibrosis-inducing mechanisms within the PI3K-AKT and JAK-STAT pathways. To summarize, the omentum patch exhibited efficacy in reducing both tubular injury and fibrosis in CKD-affected kidneys. In particular, the omentum patch is expected to protect the organ from further degeneration and loss of function by inhibiting the progression of fibrosis.

Safety evaluation after patch treatment

A patch composed of micronized autologous omentum was fabricated using a 3D bioprinter and transplanted directly into the kidneys. Twelve weeks after transplantation, the safety was evaluated by measuring body weight, blood, and the renal resistive index. In addition, biopsy samples were histologically analyzed. The results showed no surgical complications, renal functional hematological changes, or inflammatory responses. Therefore, this study provides important insights into direct therapy to kidneys with a 3D-printed patch made of autologous tissue.

Exclusive Q&A

"I am always on the same page with patients..."

– Seoul National University College of Medicine Professor, Jung Pyo Lee

Q1. What are the CKD patients’ first impressions about the diseases, and what are their thoughts on the limited available treatment options?

A: Chronic kidney disease (CKD) can be deeply distressing from the moment of diagnosis. It is defined medically as irreversible. The most reassuring thing I can often tell patients is that “you haven’t gotten worse since your last visit.” I can’t say that their condition has improved because the nature of the disease doesn’t permit such optimism. Patients on dialysis have to undergo this treatment every other day, and it is also challenging and depressing environment. I often ask them when they feel happy, and most of them answer casual things such as enjoying delicious food and spending time with families. However, patients on dialysis face restrictions. For example, consuming foods high in sugar, salt, or potassium can complicate their dialysis sessions. Excessive potassium intake can even be fatal. A kidney transplantation can be a solution for the patients, however not everyone can receive it when they want to. They often have to wait nearly a decade, living with the uncertainty of their future. This prolonged wait often leads to pervasive feelings of depression.

Q2. I understand that you personally see and treat many patients with kidney diseases and perform kidney transplant surgeries, often with foreign patients. Could you share us about a memorable patient’s stories?

A: Treating transplant patients is like a journey into the lives of the patients. Organ transplantation involves complex relationships between donors and recipients, even their family backgrounds. I recall a patient from Nepal who was deeply affected by a major earthquake. The patient’s children were all studying in Korea. Many family members of the patient in Nepal died during the earthquake and many patients also died in a dialysis center. The patient was going through a very tough situation at that time, and her children decided to bring her to Korea for treatment and transplantation.Treating foreign patients can be challenging due to the need for agreements between countries. However, when all the necessary processes were completed, the daughter donated her kidney to her mother, and the transplantation was successful. It was memorable that the patient received the successful treatments regardless of all the challenges including language barriers, and even document works.

Q3. I believe that you have seen many patient cases, and there must have been good cases of course, and bad cases on the other hand. When do you feel the most satisfied as a doctor?

A: I am always on the same page with patients. I, as a doctor, also go through many emotional phases when seeing patients. As a nephrologist, I’m involved in their lives for long durations, sometimes up to a decade, understanding their personal journeys and needs. This always encourages me to take care of them with best available treatments. Many CKD patients grapple with infertility. However, after transplantation, about 1-2 years later, they can prepare for pregnancy again. There’s a child that one of my patients gave a birth after transplantation surgery. I often see the kid with the patient, and I personally feel very touched when patients that I see are having satisfactory life after having transplantations.

Q4. There are other efforts that you are putting for your patients, can you please explain some of them?

A: From a medical perspective, I’m trying to delay the progression of CKD. Some patients don’t know much about their condition, especially if they are elderly. Delaying progression to dialysis or end-stage renal disease is a significant achievement, considering that the medical condition is not reversible. Even in people with normal kidney function, it deteriorates by about 1% per year. CKD patients deteriorate at a rate of 2-4% per year. Managing proteinuria, blood pressure, and diabetes can delay the time until dialysis, allowing more time for travel and enjoying life. Moreover, for patients who receive dialysis or transplantation, preparation is crucial. If they receive dialysis unprepared, there can be many side effects, including malnutrition and difficulty walking. I make efforts to prepare patients to minimize such situations. I also perform various research both clinical and basic researches. In basic research, since CKD is considered irreversible, I am trying to find ways to make it reversible. The main mechanism of CKD is fibrosis, so we are looking various approaches to prevent renal fibrosis.

Q5. I am aware that you are working on a research project with ROKIT HEALTHCARE. Can you briefly introduce the content of this project?

A: ROKIT HEALTHCARE has been working on organ regeneration projects for a long time, and there were chances where I met Dr. Jina Ryu and provided advice on ROKIT’s kidney regeneration projects.

Since then, I have been aware of the project, and found chances to apply for a national research grant. My research team from Seoul National University College of Medicine, the kidney transplant team from Asan Medical Center, and the kidney regeneration team from ROKIT HEALTHCARE are collaborating on a research project to develop innovative CKD treatments. The concept of this project is harvesting autologous tissue from patients and apply it to the damaged kidney. This project’s concept is good that we expect that there are no immune rejections, at least, or having harmful results for patients due to autologous sources.

I have quite good expectations based on the results of basic experiments. Considering that there are no alternative treatments, the results of the projects would greatly affect patients with CKD.

Q6. Finally, if you have any specific expectations about Kidney Regeneration Platforms or ROKIT HEALTHCARE, can you please share?

A: I think ROKIT HEALTHCARE is conducting very innovative treatment methods. Developing a treatment is a long and difficult process to commercialize it and see results. Everyone faces difficulties in development period. Even though the company may face those challenges before making the treatment commercialized, I sincerely hope that all employees come together and overcome the challenges. Moreover, I know that “K” in ROKIT stands for Korea, right? Korea is renowned for its “K-culture”, and already ahead in entertainment and IT. However, unfortunately, in the field of bio-science, Korea has not been able to show its strength yet. ROKIT has the potential to lead and define “K-bio” trends. I, as a doctor, also do my best in working for researching CKD treatments with ROKIT team, and I eagerly anticipate making a significant difference for patients lacking other treatment options.

"I am always on the same page with patients … I’m involved in their lives for long durations, understanding their personal journeys and needs."

Kidney Regeneration

From blueprint to reality: Introducing organ regeneration with advanced 3D bioprinting and AI technology on Jeju Island.

ROKIT HEALTHCARE was invited to fall meeting of the Korean Society for Biomaterials (KSBM) held at Jeju Shinhwa World on September 21-22 to deliver a presentation during the Advanced 3D Bioprinting Technology session. The presentation was titled “From Blueprint to Bioprint: Regenerative Medicine with 3D Bioprinting and Decellularization Technologies.”

During the session, Dr. Ryu showcased real-world applications of 3D bioprinting technology in the field of medicine, going beyond the research stage. The focus was particularly on chronic diseases for which current treatment methods are often inadequate. Researchers in attendance expressed astonishment at the potential of 3D bioprinters to treat patients, with one remarking, “It’s amazing that 3D bioprinters can be used to treat patients like this. We look forward to seeing more positive research outcomes.”

Dr. Ryu, who delivered the presentation, emphasized, “Many researchers are working diligently to develop 3D bioprinting technology. All these efforts are now being applied in regenerative medicine, transitioning from blueprint to reality.”

The Korean Society for Biomaterials, founded in 1996, is a large society with a membership of over 4,173 individuals. Furthermore, its official journal, Biomaterials Research, is indexed in SCIE with an impact factor of 11.3 in 2023. In 2024, the society is set to host the 12th World Biomaterials Congress (WBC 2024) in Daegu, Korea.

Organ Regeneration

Top innovator of the Asia-Pacific Digital Transformation, leading a digital-first future in Seoul

ROKIT Healthcare won the grand prize at the “GSMA Asia-Pacific Digital Transformation Summit Forum”. ROKIT Healthcare, which is attracting attention as a organ regeneration platform, has received great attention from judges and participants by introducing a personalized skin regeneration platform using 3D printing. ROKIT Healthcare’s platform uses tissues extracted from the patient’s body as bioink materials to create regenerative skin tissues that can be used directly in the operating room. In particular, it is evaluated as a new treatment to regenerate necrotic foot skin tissue in diabetics.16 domestic and foreign innovative technology startups from six countries, including Korea, Japan, Indonesia, India, Pakistan, and Sweden, participated in the event on September 8 to hold a showcase session for technology companies.The “GSMA Asia-Pacific Digital Transformation Summit Forum” was jointly held in Seoul on September 8 by the Global Digital Innovation Network and the Global Association of Mobile Communications Operators (GSMA). At the center of the event was a showcase session for technology companies involving 16 domestic and foreign innovative technology startups from six countries, including Korea, Japan, Indonesia, India, Pakistan and Sweden, in four areas: “Artificial Intelligence, Machine Learning,” “Intelligent City,” “Life Technology,” and “ESG, Sustainability.”ROKIT Healthcare won the grand prize. ROKIT Healthcare, which is attracting attention as a long-term regeneration platform, has received great attention from judges and participants by introducing a personalized skin regeneration platform using 3D printing. ROKIT Healthcare’s platform uses tissues extracted from the patient’s body as bioink materials to create regenerative skin tissues that can be used directly in the operating room. In particular, it is evaluated as a new treatment to regenerate necrotic foot skin tissue in diabetics.In addition, health-on-cloud, which introduced a cloud-based medical gap solution in the ITNJ ‘life technology’ field, which introduced artificial intelligence-based smart factory solutions, Dwelling, which exhibited IoT-based smart stations safe from fine dust and smoke, and ESG, sustainability were selected.

Top Innovator Award at the Innovative Tech Start-up Showcase, M360 APAC

The grand prize for ROKIT Healthcare is significant in that key officials of the world’s prestigious association on digital standards view ROKIT Healthcare’s AI BIOPRINTING long-term regeneration therapy as a major technology for “digital healthcare.” The GSM Association (GSM Association) is an association of MNO and related companies established in 1995 to help standardize, deploy, and encourage the use of GSM mobile phones, and is a world-renowned organization that holds the Barcelona Mobile Congress every February.

GSMA APA (2023, September 13) Congratulations to Rokit Healthcare for receiving the Top Innovator Award at the Innovative Tech Start-up Showcase at M360 APAC in Seoul Korea. [Post]. LinkedIn. https://www.linkedin.com/posts/gsmaapac_congratulations-to-rokit-healthcare-for-receiving-activity-7106063809965957120-Xjq9?utm_source=li_share&utm_content=feedcontent&utm_medium=g_dt_web&utm_campaign=copy