Stem Cell Therapy for Chronic Liver Disease in New Delhi, India

Introduction

Chronic kidney disease (CKD) is rapidly becoming one of the largest global health problems, particularly in India because of extremely high morbidity and mortality rates associated with CKD. The World Health Organization (WHO) said kidney disease is a major cause of morbidity and mortality in many countries, including India. There have been more than 1.3 million deaths from CKD worldwide in 2019, and approximately 17% of the Indian population has some form of kidney disease, with millions living with end-stage renal disease (ESRD) for which they will either require dialysis or kidney transplantation. Conventional treatments for CKD in India of dialysis and kidney transplantation may not always cure kidney disease, and they have high cost, shortage of organs for transplantation, and patient morbidity associated with treatment.

Current advancements in stem cell therapy offer new treatment options for chronic kidney disease by potentially providing the ability to repair or regenerate damaged kidney tissue. Stem cell therapy attempts to use the regenerative potential of stem cells to repair damaged organs, restore kidney function, and delay or avoid dialysis or transplant. Stem cell therapy for chronic kidney disease is still experimental, but there is considerable interest in its use for kidney diseases, especially in cities such as New Delhi, where health care infrastructure is lacking.

This paper reviews the role for stem cell therapy in managing chronic kidney disease in New Delhi, India. This paper will discuss potential benefits, current knowledge for scientific research and clinical practice, clinical ethics issues, and the potential future for this type of intervention.

Becoming Acquainted With CKD

Chronic kidney disease (CKD) is the progressive loss of kidney function due to existing diseases such as diabetes and hypertension, glomerulonephritis and polycystic kidney disease. Kidneys are really important organs that do the important upkeep of filtering waste and balancing electrolytes and fluids, which means that as the amount of healthy kidney tissue decreases, harmful substances build up in the body, causing symptoms like swelling, tiredness, trouble urinating, and increased blood pressure. In later stage CKD, when the body is unable to maintain these essential functions, there will be progression into end-stage renal disease (ESRD), thus making dialysis or a kidney transplant the only available interventions that will prolong life.

Stem Cells and Kidney Regeneration

Stem cells are specialized cells that can divide and differentiate into many specialized/terminal cell types. Depending on the source, stem cells can be differentiated into categories like embryonic stem cells (ESCs), adult stem cells, and induced pluripotent stem cells (iPSCs). Kidney stem cell therapy relies on these properties of stem cells that help normal kidney tissues repair and regenerate damaged and dysfunctional kidney tissues.

The kidneys have limited autonomous regenerative capabilities, particularly in instances of severe injury from CKD; stem cells have demonstrated the potential to regenerate kidney damage and improve kidney function while potentially decreasing the need for dialysis in preclinical studies or early clinical trials.

Mechanisms of stem cell therapy for CKD include:

• Cell Replacement: Stem cells can differentiate into kidney cells (i.e., nephron progenitors), which could replace injured or dead cells in the kidneys, causing improvement in function.
• Tissue Regeneration: Stem cells can secrete growth factors and cytokines, which can regenerate and repair tissue.
• Anti-inflammatory: Stem cells can decrease inflammation in the kidneys, which is a common part of CKD progression.
• Angiogenesis: Stem cells can create new blood vessels (angiogenesis), improving blood supply and function in the kidneys.

Stem Cell Therapy in New Delhi, India

India, and New Delhi specifically, is emerging as a location for some new treatments like stem-cell therapy. In the last ten years, research and clinical interest in stem-cell-based therapies has increased for many medical illnesses, including CKD. Many healthcare facilities in New Delhi are involved in clinical trials and research for CKD using stem cell therapies.

Major Players and Institutions

• The Institute of Liver and Biliary Sciences (ILBS): ILBS in New Delhi provides an outstanding new facility and is one of the top centers in India conducting stem cell research. Research at ILBS is working with mesenchymal stem cells (MSCs), as well as other forms of adult stem cells, as treatments for CKD. ILBS is conducting clinical trials using stem cells with the intent of regenerating kidney tissues and restoring renal function.
• Medtravellers—Another major healthcare provider in New Delhi, Medtravellers is also a clinical and research trial participant for kidney diseases using stem cell therapy. Medtravellers also teams with multiple biotechnology companies to expand mechanisms of action for stem cell-based regenerative medicine.
• Stem Cell Centers—In addition, there are several private clinics and hospitals in New Delhi that are executing stem cell therapies for kidney diseases soon.

Types of stem cells used for CKD treatment

• Mesenchymal Stem Cells (MSCs): MSCs are the most used stem cells for treatment of CKD. They are multipotent stem cells that have the potential to differentiate into a variety of cells, including kidney cells. MSCs are typically harvested from assorted adult tissues (e.g., bone marrow, adipose tissue, and umbilical cord tissue). MSCs are good therapeutic stem cells for kidney damage because of their regenerative healing properties, including their stimulation of anti-inflammatory cytokine secretion.
• Induced Pluripotent Stem Cells (iPSCs): iPSCs are somatic cells that have been genetically reprogrammed to have the same gene expression profile as embryonic stem cells. iPSCs can differentiate into any type of cell, including renal cells. iPSCs are still experimental, and much additional research is needed to establish the safety and clinical utility of iPSCs as a treatment for CKD.

Benefits of Stem Cell Therapy for Chronic Kidney Disease

There are many potential advantages to using stem cell therapy in treating CKD compared to traditional treatments:

• Regenerative Ability: Stem cells have the potential to restore injured tissue and improve kidney function. This could mean these patients may avoid dialysis or transplantation.
• Reduces Inflammation: Stem cells may assist in decreasing inflammation of the kidneys which is a major contributor in the progression of CKD
• Quality of Life: Patients treated with stem cells may see all of the symptoms of CKD improve, like fatigue, edema or shortness of breath as their kidney function improves. 
• Minimizes Rejection Risk: If a patient receives stem cells from his/her body (autologous transplant), their risk of rejection will be near zero.

Concerns and Drawbacks 

While stem cell therapy for CKD offers potential opportunities for them, several concerns still exist:

• Safety: Stem cell therapies can have safety concerns. These can vary from tumor formation, immune rejection (of the transplant), and complications. There is still limited safety data on long-term outcomes. 
• Standardizing: There has been standardization on how to harvest, culture, and administer the stem cells; however, there are still no protocols to clinical standards to standardize stem cell-based treatments, which will ultimately not allow comparison of clinical application successes or failures. 
• Regulation: There is no regulation of stem cell therapy in India, no guidelines or regulations that protect consumers for treatment and safety, minority ethics, or their clinical use of stem cells. 
• Cost: Stem cell therapy for CKD is beyond many patients’ reach, even more so for lower-income patients. The costs include not just the cost of the treatment but also the cost of ongoing monitoring and management of the patient afterwards.

Ethical Issues

Stem cell therapy, especially from embryonic sources, raises ethical issues with respect to the source of the cells, their manipulation or alteration, and sometimes, their cloning. In India, embryonic stem cells are regulated by the Indian Council of Medical Research (ICMR) with their guidelines for acceptable ethical use for research and treatment. As with adult stem cells and iPSCs, there are ethical issues that relate to consent, the source of the donor, and commercialization of sources of stem cells.

Presently available stem cell therapy for CKD in New Delhi

Stem cell therapy for CKD is in its infancy, though several centers in New Delhi have reported encouraging clinical trial results. One of the more notable studies was carried out at the Institute of Liver and Biliary Sciences (ILBS), which reported that patients with CKD who received MSC-based therapy showed improved kidney function, decreased inflammation, and reduction of proteinuria (deviation from normal amounts of protein in urine). As of now, these results are preliminary, and more extensive clinical trials are needed to verify the long-term efficacy and safety of stem cell therapies for CKD.

Future Opportunities

The future of stem cell therapy for CKD in New Delhi and in India looks very bright. As research expands with more clinical trials, stem cell therapies could advance as treatment modalities for CKD patients, which could decrease the burden on dialysis centers and organ transplant registries. Moreover, the advances of genetic engineering, bioengineering, and bioprinting may help stem cells produce significant functional kidney tissues, which will be auspicious at a time when the odds of receiving organ transplants will no longer depend on luck. 

The Indian government and regulatory agencies have started to support stem cell research. In 2021, the Indian government was proactive in laying down guidelines to regulate stem cell therapy and stem cell research, opening more clinical possibilities and a stronger framework for research.

Conclusion

Stem cell therapy provides a new option for the treatment of chronic kidney disease with the capacity to regenerate diseased kidney tissues (and renal function) in patients who might otherwise need dialysis or a kidney transplant. In New Delhi, India, some of the top institutions in the country are spearheading this effort, and especially the research and clinical work examining the safety and efficacy of stem cell therapies in CKD.

FAQs

1. How does stem cell therapy handle chronic kidney disease?

Stem cell therapy repairs damaged kidney tissue utilizing the regenerative properties of stem cells through multiple mechanisms. Stem cells can differentiate into kidney cells, providing a source to replace damaged tissue. The stem cell agents can secrete growth factors that promote healing, attenuate inflammation, directly leading to the reduced progression of the underlying CKD, or induce further blood vessel formation to increase kidney operation. In sum, stem cell therapy has the potential to restore function and lessen or eliminate the need for dialysis and transplant.

2. What type of stem cells are used for CKD in New Delhi?

The most common stem cells used in New Delhi are Mesenchymal Stem Cells (MSCs), which come from a patient’s bone marrow, fat tissue, or umbilical cord. MSCs are commonly used because they have high regenerative properties and have a very low risk of rejection because they can be harvested from the patient. Induced Pluripotent Stem Cells (iPSCs) are of strong interest; however, they are still under investigation and potentially unsafe for clinical practice until more safety studies have been established.

3. What benefits are there compared to classic CKD treatments?

Stem cell therapy has a number of advantages over current treatment options like dialysis and transplant. The advantages include, but are not limited to, stem cells having the ability to actually regenerate damaged kidney tissue rather than just treat the symptoms of CKD; stem cell therapy having the ability to decrease chronic kidney inflammation and the potential to improve patient quality of life by improving CKD symptoms like fatigue and edema; it having been suggested that there is a lower risk of transplant rejection when using the patient’s own stem cells; and stem cell therapy perhaps postponing or alleviating the need for dialysis or kidney transplant.

4. Is stem cell therapy for CKD safe and available?

Stem cell therapy for CKD is in its early experimental phase generally, and there is limited long-term safety data to support its use. The risks of stem cell therapy can include, but are not limited to, tumor formation, immune response, and other morbidities. The only option to receive stem cell therapy for CKD is for patients to enroll in a clinical trial at a major hospital or research center (e.g., the Institute of Liver and Biliary Sciences (ILBS) in New Delhi). CDC prints some promising early results with extra improvement in kidney function and decreased inflammation, but as with any new experimental therapy, extensive clinical trials must be conducted before it can be established as a standard therapy, and claims of patient improvement years later will not be published research for several years.