Bangladesh-born scientist, Dr Shuvo Roy, is leading research at University of California, San Francisco (UCSF), to develop the world’s first artificial kidney—a compact, surgically implanted, free-standing device to treat End-Stage Renal Disease (ESRD).
ESRD, the last stage of Chronic Kidney Disease (CKD), signals near-complete-to-total kidney failure. As a result, the kidneys cannot perform their normal, life-essential roles of removing naturally occurring, but toxic, by-products of metabolism from the blood; removing excess water and salts from the blood to maintain blood pressure; and replenishing proper amounts of chemicals in the blood, such as, sodium, phosphorus, and potassium, to maintain acid-base and electrolyte balance.

Because of the critical and varied roles the kidneys play, many patients whose kidneys fail become extremely ill and suffer high cardiovascular and infectious mortality. Without treatment, ESRD patients will die.
Arguably, Dr Roy's project, named simply, and perhaps prophetically, The Kidney Project, offers the best hope for the millions of patients afflicted with ESRD, who have to rely on regular dialysis, which, at the best, is short-term, and makes leading a normal life virtually impossible.
The only way out for such patients is to go for a kidney transplant, but given the short supply in donor organs that is often not feasible.

The early prototype of the coffee-cup-sized device is now undergoing intense testing at UCSF labs, and is expected to start clinical trials in 2017, says Dr Roy.
The device is unique in the way that it builds upon the existing extracorporeal renal assist device (RAD), which is a bio-artificial kidney that combines a membrane hemofilter and a bioreactor of human renal tubule cells to mimic many of the metabolic, endocrine, and immunological functions of a healthy kidney.
While clinical trials confirmed that the RAD can safely treat acute renal failure in a critical care setting, adoption of the RAD for routine treatment of ESRD patients is hampered by its labor-intensive and complex operation, large size, and high marginal cost. The ultimate goal of The Kidney Project is to apply micro-electromechanical systems (MEMS) and nanotechnology to miniaturise the extracorporeal RAD into a surgically implantable, self-monitoring, and self-regulating bio-artificial kidney.
After a single surgery to establish a permanent blood connection, the bio-artificial kidney processes blood continuously for 24 hours per day, which mitigates the inconveniences and morbidities associated with intermittent hemodialysis.

There are several benefits to the implantable bio-artificial kidney including the alleviation of the necessity of constant physician oversight and a heavy regimen of immunosuppressant drugs and medication.
The importance of The Kidney Project can be judged from the fact that the US FDA incorporated the project in its Innovation Pathway 2.0 programme, an evolving system designed to help safe, break-through medical products reach patients in a timely manner. According to the US FDA, “the Pathway ultimately aims to shorten the overall time and cost it takes for the development, assessment and review of medical devices”, making it possible to help deliver vital life-saving solutions on a fast-track basis.

What is the current status of development? When do you expect this to be available in the market?
We are currently building and testing increasingly complex prototypes in stages for pre-clinical studies. We are also working with the US FDA to define the pathway for regulatory approval of the artificial kidney. The effort involves close contact between the FDA and our team, to identify and address potential scientific and regulatory hurdles, and create a roadmap for approval. We hope that the Innovation Pathway 2.0 will improve our overall chance of success, while reducing the time and cost of FDA review, and ensuring patient safety. We are targeting clinical trials to start in 2017.

What will be the key functions of the artificial kidney? How close this will be to a real kidney, in terms of functionality?
The artificial kidney will provide the health benefits of a transplanted organ while addressing the limited number of donors. The device filters toxins from the blood, while also providing other biological functions of a healthy kidney, such as auto-regulation of blood pressure and production of Vitamin D.
 
What are the key technologies being used to develop this device?
The artificial kidney combines a hemofilter to remove toxins with a bioreactor, to provide other biological functions of a healthy kidney.

For the hemofilter, we use silicon nanotechnology to produce a highly efficient and compact membrane, which relies on the body’s blood pressure to perform filtration without needing pumps or power supply. For the cell bioreactor, we are applying recent advances in the field of tissue engineering to grow renal tubule cells.

Is it possible to indicate any potential price range for such a device?
It’s difficult to prospectively put a price tag on the ultimate price of the device when it reaches the marketplace. We are hopeful that the cost for the artificial kidney will likely be less than that of a transplant.

Once an artificial kidney is implanted, what would be the follow-up/check-up procedures? What would be the expected service life of the device?
The device is designed to be long-term, if not permanent, implant. We anticipate that patients will require regular check-ups with their doctors similar to those who receive kidney transplants today.

What is the level of interest/engagement of pharma/medical devices companies, in this project?
We have received interest from a variety of companies, and we are looking forward to partnerships with them, to bring the artificial kidney to patients.

Do you have any other researchers in your team from Bangladesh, or the Indian sub-continent?
My family is from Bangladesh, and I have many relatives in India. Our research team includes a number people with Indian and Bangladeshi roots. These members include students, post-doctoral fellows, academic colleagues, and business advisers. (Reprint)