환자가 자주 묻는 질문
주요 질문:
- 생체인공신장 상태는 어떤가요?
이식 가능한 생체인공신장은 개발 중이며 임상시험은 시작하지 않았습니다. 우리는 장치의 주요 기능 구성 요소(혈액 여과기와 생물 반응기)가 소규모 프로토타입을 사용하여 동물에서 의도한 대로 함께 작동한다는 것을 보여주었습니다. 이는 장치가 충분한 용량으로 확장되면 인간에게도 작동할 것이라는 확신을 줍니다. 이 비디오는 최신 진행 상황을 요약합니다. - 임상시험은 언제 시작되나요?
기술적인 측면에서 인공신장의 임상시험 준비까지는 4~5년 정도 걸릴 것으로 추정된다. 그러나 전임상 개발을 완료하는 데 필요한 모든 자금(1천만 달러로 추정)이 아직 확보되지 않았으므로 이 일정은 더 느려질 수 있습니다. - 생체인공신장은 언제 환자에게 제공되나요?
인공 신장은 미국 식품의약국(FDA)의 광범위한 사용 승인을 받기 전에 여러 차례의 임상 시험을 거쳐야 합니다. 우리의 목표는 10년 말(2030년)까지 장치를 상용화하는 것입니다. 하지만 이는 자금 상황에 따라 다르며 예상치 못한 기술적 문제로 인해 속도가 느려질 수도 있습니다. - 인공 신장은 국제적으로 이용 가능합니까? 아니면 국제 환자들이 시술을 위해 미국으로 가야 합니까?
인공 신장이 FDA의 승인을 받으면 우리는 국제 규제 기관과 협력하여 이 장치를 전 세계에서 사용할 수 있도록 할 것입니다. 국제 승인은 미국 승인보다 2년 정도 늦어질 가능성이 높습니다. 해외 환자의 경우 상황에 따라 그동안 시술을 위해 미국으로 여행을 갈 수도 있습니다. - 이식 가능한 생체인공신장을 기다리고 있는데 의사가 투석을 시작하고 신장이식 명단에 오르라고 권유하고 있습니다. 어떻게 해야 하나요?
귀하는 항상 담당 의사나 기타 자격을 갖춘 의료 서비스 제공자의 조언에 귀를 기울여야 합니다. 이식 가능한 생체인공신장은 아직 개발 중이며 아직 환자에게 제공되지 않습니다. 권장되는 치료를 미루지 마십시오. - 신장 질환이 있는 환자도 이식형 생체인공신장을 이용할 수 있나요?
확실하게 말할 수는 없지만, 신장 이식이 필요한 경우에는 우리 장치가 선택 사항이 될 것으로 기대합니다. 그러나 개인별 상황은 다르며 향후 적격성은 항상 귀하의 의료 서비스 제공자에 의해 결정됩니다. - 이 장치의 가격은 얼마입니까? 보험으로 보장되나요?
인공 신장의 비용은 장치가 시장에 출시되는 시점의 비즈니스 및 경제 상황에 따라 달라집니다. 우리는 이 장치의 비용이 이식 비용보다 높지 않을 것으로 예상합니다. 장치가 임상 시험에 들어가면 Medicare와 상업 보험사 모두에 보험 적용을 신청할 것입니다.
기본사항: 장치 및 기능
8.인공신장은 어떻게 작동하나요? 얼마나 크나요?
이식 가능한 생체인공신장은 커피컵 크기 정도이며 노폐물을 제거하기 위해 함께 작동하는 두 가지 주요 구성 요소로 구성됩니다. 첫째, 혈액여과기 또는 혈액 필터는 유입되는 혈액을 처리하여 용해된 독소, 설탕 및 염분을 포함하는 “초여과액”을 생성합니다. 둘째, 신장 세포를 포함하는 생물반응기는 한외여과액을 처리하여 방광으로 향하는 “소변”으로 농축합니다.
- 인공신장이 인간 신장만큼 기능을 발휘할 수 있을까요?
인공 신장은 자연 신장과 같은 기능을 하도록 설계되어 혈액을 여과하고 체액 균형을 유지하므로 투석이 필요하지 않습니다. 장치의 첫 번째 버전은 이식이나 건강한 자연 신장만큼 신장 기능을 제공하지는 않지만 환자가 투석을 하지 않도록 하는 데는 충분합니다. 기술이 발전함에 따라 이후 버전에서는 장치 성능이 향상될 것입니다. - 장치를 이식하는 수술은 어떤가요?
이식 절차는 신장 이식 수술과 유사하며 입원과 전신 마취가 필요합니다. - 이식 후 장치는 얼마나 오래 지속되나요? 교체해야합니까?
이 장치는 영구적으로 사용됩니다. 현재 테스트와 연구에 따르면 이 장치는 수년 동안 고장 없이 작동할 수 있습니다. 고장이 발생하면 최소 침습 수술을 통해 필터 및/또는 세포를 교체할 수 있습니다. - 필터는 어떻게 청소하나요?
필터는 청소나 교체가 필요하지 않습니다. 막힘과 혈전을 방지하기 위해 얇은 생체 적합성 코팅이 필터 멤브레인에 적용됩니다. 코팅된 필터 표면 위로 혈액이 지속적으로 흐르면 멤브레인에 잔해물이 없도록 유지하는 데에도 도움이 됩니다. - 이식 후에도 환자는 면역억제제나 혈액 희석제를 복용해야 합니까? 혈전의 위험이 있습니까?
아니요. 인공신장에 사용되는 막의 구멍은 면역세포나 항체의 크기보다 작습니다. 이와 같이 신장
Frequently Asked Questions by Patients
Top Questions:
1. What is the status of the bioartificial kidney?
The implantable bioartificial kidney is under development, and we have not begun clinical trials. We have shown that the main functional components of the device (the hemofilter and the bioreactor) work together as intended in animals using small-scale prototypes. This gives us confidence that it will work in humans once the device is scaled up with enough capacity. This video summarizes our latest progress:
2. When will clinical trials start?
We estimate that the artificial kidney is about 4-5 years away from being ready for clinical trials from a technical perspective. However, we do not yet have all the funding we need (estimated at USD 10 million) to complete the preclinical development, so this timeline could be slower.
3. When will the bioartificial kidney be available for patients?
The artificial kidney must undergo multiple rounds of clinical trials before it is approved by the U.S. Food & Drug Administration (FDA) for widespread use. Our goal is to have a device commercially available by the end of the decade (2030), but again this depends on our funding situation, and it is possible that unanticipated technical challenges could slow us down.
4. Will the artificial kidney be available internationally? Or will international patients have to go to the United States for the procedure?
Once the artificial kidney is approved by the FDA, we will work with international regulatory agencies to make the device available around the world. International approvals will likely be a couple of years behind U.S. approval. It is possible that international patients may be able to travel to the U.S. for the procedure in the meantime, depending on their situation.
5. I am waiting for the implantable bioartificial kidney, but my doctor is recommending that I start dialysis and get on the kidney transplant list. What should I do?
You should always heed the advice of your physician or other qualified health provider. The implantable bioartificial kidney is still under development and is not yet available for patients. Please do not delay any recommended treatments.
6. Will patients with any kind of kidney disease be eligible for the implantable bioartificial kidney?
We cannot say definitively, but we expect that in any case where a kidney transplant is needed, our device will be an option. However, individual situations differ, and future eligibility will always be determined by your health care provider.
7. How much will this device cost? Will it be covered by insurance?
The cost of the artificial kidney will depend on the business and economic climate at the time the device is released on the market. We expect that the device will cost no more than a transplant. We will apply for insurance coverage by both Medicare and commercial insurers once the device is in clinical trials.
Basics: device and function
8.How does the artificial kidney work? How big is it?
The implantable bioartificial kidney is about the size of a coffee cup and consists of two main components that work together to get rid of wastes. First, the hemofilter, or blood filter, processes incoming blood to create “ultrafiltrate” that contains dissolved toxins, sugars, and salts. Second, a bioreactor containing kidney cells processes the ultrafiltrate and concentrates it into “urine,” which is directed to the bladder.
9. Will the artificial kidney work as well as a human kidney?
The artificial kidney is designed to work like the natural kidney, filtering the blood and maintaining the body’s fluid balance so that dialysis is not necessary. The first versions of the device will not provide as much kidney function as a transplant or a healthy natural kidney, but enough to keep patients off dialysis. Device performance will improve in later versions with advances in technology.
10. What is the surgery like to implant the device?
The implantation procedure will be similar to kidney transplant surgery and will require a hospital stay and general anesthesia.
11. How long will the device last after implantation? Will it have to be replaced?
The device is meant to be permanent. Current testing and research suggest that the device could operate for many years without failure. If failures occur, the replacement of the filter and/or cells could be done through minimally invasive surgery.
12. How will the filter be cleaned?
The filter will not require cleaning or replacement. A thin biocompatible coating is applied to the filter membrane to help prevent clogging and blood clots. The constant flowing of blood over the coated filter surface also helps keep the membrane free of debris.
13. Will patients still have to take immunosuppressive drugs or blood thinners after implantation? Will there be a risk of blood clots?
No. The pores in the membranes used in the artificial kidney are smaller than the size of immune cells and antibodies. As such, the kidney cells in the bioreactor stay isolated from the patient’s immune system. We also do not expect that patients will need to take blood thinning medications like warfarin. The coatings and geometry of the device are designed to prevent formation of blood clots.
14. Will patients still need Erythropoietin (EPO) injections?
Yes. The type of kidney cell in the bioreactor is different than the cells that secrete erythropoietin, so patients will still need supplemental EPO.
15. What kind of GFR value would you expect to see with the artificial kidney?
We are targeting a glomerular filtration rate (GFR) of 20-30 ml/min with the first version of the artificial kidney. We expect that future versions of the device will provide a higher GFR.
16. Can you still get this device if you still have some level of kidney function, or is this only for patients with end-stage kidney disease (ESKD)?
This device is intended for patients with ESKD, defined as a GFR of 15 ml/min or less. It is possible that eligibility could eventually be broadened to patients not yet in renal failure.
17. Are there any predicted side effects?
Some risks will be similar to those associated with other procedures involving implanted medical devices. These include potential complications like infections, surgical trauma, and scars. We will know more about possible side effects once we begin clinical trials.
18. What is iHemo?
iHemo is the name of the implanted dialysis device we are developing. iHemo uses the implantable bioartificial kidney’s blood filter (hemofilter) to perform hemodialysis inside the body – without requiring needles and without any blood leaving the body. Only dialysate cycles in and out through an external pump using a catheter connection.
You can learn more about iHemo and how it works here:
19. What is the status of preclinical testing?
Over the past 15 years, the project has progressed from establishing the scientific foundations and technical methods to showing that the device’s key mechanisms work in animals. Recently, a small-scale prototype was implanted into a pig and successfully produced urine over 3 days. We are iteratively refining our device design to create prototypes that will have the capacity to treat human patients for extended periods.
20. Where can I find updates regarding the progress of the project?
Our Facebook page is a great place to stay informed about our progress. You can also follow us on Instagram, YouTube, LinkedIn, and Twitter.
Facebook: @ArtificialKidney
Instagram: @ArtificialKidney
YouTube: @TheKidneyProject
LinkedIn: The Kidney Project
We are also starting up a newsletter! To get updates sent straight to your email, sign up here.
Funding
21. What kind of federal funding do you receive?
The Kidney Project has been awarded grants from the National Institutes of Health (NIH), National Aeronautics and Space Administration (NASA), National Science Foundation (NSF), and Department of Defense (DOD). We have also received funding from the Kidney Innovation Accelerator (KidneyX), a public-private partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN) launched in 2018.
22. How much funding does The Kidney Project need to complete its work?
We estimate that we need roughly USD 10 million over the next 3-4 years to complete preclinical development of the implantable bioartificial kidney and request approval for human studies. If the funding goals are not met, the timeline for the completion of the device could be extended.
It is critical that we secure larger funding commitments that will allow us to take the necessary steps necessary to scale up our device for human clinical trials. Once we reach the clinical trial stage, we are optimistic that support from private investors and industry partners will enable us to complete the commercialization process.
23. How can I make a donation?
Online
- Make checks payable to UCSF Foundation.
- Include allocation instructions on the memo line: The Kidney Project.
- Send gifts by U.S. Mail to:UCSF
P.O. Box 45339
San Francisco, CA 94145-0339
Phone
Call toll-free 877-499-UCSF (877-499-8273) to charge by phone.
Clinical Trials
24. Do you have a waitlist for clinical trials? How do I sign up?
We are still a few years away from beginning clinical trials and do not maintain a waitlist. If you are interested in being notified once our trials do start enrolling, please complete this form to submit your information to our database:
Please note that the interest list does not guarantee anyone’s participation. It only means that you will be notified when enrollment has opened. It is not necessary to be on the list to be considered. We will announce trial openings via ClinicalTrials.gov and our social media pages once we are ready to begin enrollment.
25. What are the criteria for choosing the first group of clinical trials patients? Who decides who will participate?
Patient selection for trials will be based on the trial inclusion criteria, which will be developed by our clinical team and reviewed and approved by the FDA and our Institutional Review Board (IRB). Specific patient selection criteria have not been determined at this time.
26. If I donate, will that increase my chances of participation?
While donations are appreciated and serve a vital role in our work, donations have absolutely no influence on selection for trials. This is to protect the integrity of our research and ensure that all participant decisions are made for medically and scientifically sound reasons.
27. Where will the clinical trials take place?
The first clinical trial will mostly likely take place at either UCSF Medical Center (San Francisco, California) or Vanderbilt University Medical Center (Nashville, Tennessee), because this is where The Kidney Project’s leadership is located. Further trials will take place at multiple locations within the United States. The specific institutions are not known at this time.
28. Will international patients be considered?
International patients will certainly be considered. However, due to the study logistics and the need for long-term follow-up, it is likely that most participants will be based in the United States.
Last updated on February 16, 2024.
