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https://clinicaltrials.gov/ct2/show/NCT05340426?term="Xenotransplantation"+"renal"&draw=2&rank=1
Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease
Sponsor:
University of Alabama at Birmingham
Collaborators:
United Therapeutics
Lung Biotechnology PBC
Information provided by (Responsible Party):
Jayme E Locke, University of Alabama at Birmingham
Study Description
Brief Summary:
The mismatch between organ supply and demand results in the deaths of thousands of Americans each year. Our research group aims to solve this unmitigated health care crisis by translating advances in xenotransplantation to humans and expanding organ supply in a sustainable fashion using genetically modified pigs as a source of organs. We propose here a phase I clinical trial of porcine kidney xenotransplantation into 20 people with end-stage kidney disease. Source donor animals are pigs with 10 gene edits (10-GE) which attenuate immunologic harm to the kidney xenograft. 10-GE pigs are housed in a designated pathogen-free facility within 30 minutes of the transplantation center. Xenotransplantation procedures follow conventional practices currently employed in allotransplantation and comply with multiple regulatory standards to ensure ethical treatment of research subjects and source animals. Recruitment and xenotransplantation will occur over 5 years with study follow-up extending 1 year after xenotransplantation. Primary outcome variables surround patient safety, such as patient survival and the rate of zoonotic disease transmission. Secondary outcome variables include commonly used metrics of graft survival and function.
Condition or disease Intervention/treatment Phase
Kidney Failure, ChronicDevice: UKidneyPhase 1
Study Design
Study Type :Interventional (Clinical Trial)
Estimated Enrollment :20 participants
Allocation:N/A
Intervention Model:Single Group Assignment
Intervention Model Description:Phase I clinical trial involving the use of a porcine kidney xenograft for transplant in place of a human kidney allograft to treat chronic renal failure in patients on dialysis
Masking:None (Open Label)
Primary Purpose:Treatment
Official Title:Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease
Estimated Study Start Date :September 1, 2022
Estimated Primary Completion Date :June 30, 2027
Estimated Study Completion Date :June 30, 2028
More Information
Responsible Party:Jayme E Locke, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:NCT05340426 History of Changes
Other Study ID Numbers:IRB-300008933
First Posted:April 22, 2022 Key Record Dates
Last Update Posted:June 2, 2022
Last Verified:June 2022
临床试验准备出来了，2022年9月份开始，持续6年，有条件的可以去那边做。
Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease
Sponsor:
University of Alabama at Birmingham
Collaborators:
United Therapeutics
Lung Biotechnology PBC
Information provided by (Responsible Party):
Jayme E Locke, University of Alabama at Birmingham
Study Description
Brief Summary:
The mismatch between organ supply and demand results in the deaths of thousands of Americans each year. Our research group aims to solve this unmitigated health care crisis by translating advances in xenotransplantation to humans and expanding organ supply in a sustainable fashion using genetically modified pigs as a source of organs. We propose here a phase I clinical trial of porcine kidney xenotransplantation into 20 people with end-stage kidney disease. Source donor animals are pigs with 10 gene edits (10-GE) which attenuate immunologic harm to the kidney xenograft. 10-GE pigs are housed in a designated pathogen-free facility within 30 minutes of the transplantation center. Xenotransplantation procedures follow conventional practices currently employed in allotransplantation and comply with multiple regulatory standards to ensure ethical treatment of research subjects and source animals. Recruitment and xenotransplantation will occur over 5 years with study follow-up extending 1 year after xenotransplantation. Primary outcome variables surround patient safety, such as patient survival and the rate of zoonotic disease transmission. Secondary outcome variables include commonly used metrics of graft survival and function.
Condition or disease Intervention/treatment Phase
Kidney Failure, ChronicDevice: UKidneyPhase 1
Study Design
Study Type :Interventional (Clinical Trial)
Estimated Enrollment :20 participants
Allocation:N/A
Intervention Model:Single Group Assignment
Intervention Model Description:Phase I clinical trial involving the use of a porcine kidney xenograft for transplant in place of a human kidney allograft to treat chronic renal failure in patients on dialysis
Masking:None (Open Label)
Primary Purpose:Treatment
Official Title:Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease
Estimated Study Start Date :September 1, 2022
Estimated Primary Completion Date :June 30, 2027
Estimated Study Completion Date :June 30, 2028
More Information
Responsible Party:Jayme E Locke, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:NCT05340426 History of Changes
Other Study ID Numbers:IRB-300008933
First Posted:April 22, 2022 Key Record Dates
Last Update Posted:June 2, 2022
Last Verified:June 2022
临床试验准备出来了，2022年9月份开始，持续6年，有条件的可以去那边做。
https://jme.bmj.com/content/46/5/311
Original research
Paediatric xenotransplantation clinical trials and the right to withdraw
http://orcid.org/0000-0003-0592-2592Daniel J Hurst1, Luz A Padilla2, Wendy Walters3, James M Hunter4, David K C Cooper5, Devin M Eckhoff6, David Cleveland7, Wayne Paris8
Correspondence to Dr Daniel J Hurst, Family & Community Medicine, UAB, Birmingham, AL 35042, USA; djhurst@uab.edu
Abstract
Clinical trials of xenotransplantation (XTx) may begin early in the next decade, with kidneys from genetically modified pigs transplanted into adult humans. If successful, transplanting pig hearts into children with advanced heart failure may be the next step. Typically, clinical trials have a specified end date, and participants are aware of the amount of time they will be in the study. This is not so with XTx. The current ethical consensus is that XTx recipients must consent to lifelong monitoring. While this presents challenges to the right to withdraw in the adult population, additional and unanswered questions also linger in the paediatric population. In paediatric XTx, parents or guardians consent not only to the initial treatment of the child but also to lifelong monitoring, thus making a decision whose consequences will remain present as the child develops the capacity for assent, and finally the capacity for informed consent or refusal. This article presents and evaluates unanswered paediatric ethical questions in regard to the right to withdraw from XTx follow-up in the paediatric population.
http://dx.doi.org/10.1136/medethics-2019-105668
Publication history
Received July 1, 2019
Revised October 11, 2019
Accepted October 24, 2019
First published November 8, 2019.
Online issue publication
May 14, 2020
Article Versions
Previous version (8 November 2019).
You are viewing the most recent version of this article.
这篇说的是临床试验将会在下个十年的早期开始，不过文章发表于2019年，希望大家多多关注!!
Original research
Paediatric xenotransplantation clinical trials and the right to withdraw
http://orcid.org/0000-0003-0592-2592Daniel J Hurst1, Luz A Padilla2, Wendy Walters3, James M Hunter4, David K C Cooper5, Devin M Eckhoff6, David Cleveland7, Wayne Paris8
Correspondence to Dr Daniel J Hurst, Family & Community Medicine, UAB, Birmingham, AL 35042, USA; djhurst@uab.edu
Abstract
Clinical trials of xenotransplantation (XTx) may begin early in the next decade, with kidneys from genetically modified pigs transplanted into adult humans. If successful, transplanting pig hearts into children with advanced heart failure may be the next step. Typically, clinical trials have a specified end date, and participants are aware of the amount of time they will be in the study. This is not so with XTx. The current ethical consensus is that XTx recipients must consent to lifelong monitoring. While this presents challenges to the right to withdraw in the adult population, additional and unanswered questions also linger in the paediatric population. In paediatric XTx, parents or guardians consent not only to the initial treatment of the child but also to lifelong monitoring, thus making a decision whose consequences will remain present as the child develops the capacity for assent, and finally the capacity for informed consent or refusal. This article presents and evaluates unanswered paediatric ethical questions in regard to the right to withdraw from XTx follow-up in the paediatric population.
http://dx.doi.org/10.1136/medethics-2019-105668
Publication history
Received July 1, 2019
Revised October 11, 2019
Accepted October 24, 2019
First published November 8, 2019.
Online issue publication
May 14, 2020
Article Versions
Previous version (8 November 2019).
You are viewing the most recent version of this article.
这篇说的是临床试验将会在下个十年的早期开始，不过文章发表于2019年，希望大家多多关注!!
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