Regenerative Cellular Therapies, Physiology, Pathology and Developmental Biology (RCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02469207|
Recruitment Status : Unknown
Verified July 2016 by Dr. Kourosh Saeb-Parsy, Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : June 11, 2015
Last Update Posted : July 14, 2016
|Condition or disease||Intervention/treatment|
|Graft Rejection Transplantation Diabetes Mellitus||Other: Removal of tissue post-mortem|
The purpose of this study is to use tissue from deceased organ donors to address questions that are of importance for the development of regenerative cellular therapies for better understanding of organ physiology and developmental biology. This study aims to maximise the clinically available data as well as patient benefit that can be generated from donated tissue. It also aims to reduce number of consent forms given to patients by consolidating and coordinating a number of related investigations.
The study aims are:
- To examine function and the immune response to stem cells and their differentiated progeny as well as development of immunomodulatory approaches to prevent their rejection.
- Generation of induced pluripotent stem cells (iPSCs) and their subsequent differentiation into functional cells as potential therapies.
- Generation of differentiated cells from native adult stem cells as cellular therapies.
- Investigation of organ physiology.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||A Study Utilising Tissue From Deceased Organ Donors to Investigate Regenerative Cellular Therapies and Related Physiological and Developmental Processes|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Deceased organ donors
Patients with consent for organ donation towards transplantation and research. Organs not used for transplantation will be used for this study if determined appropriate and necessary.
Other: Removal of tissue post-mortem
- Number of donors from which induced Pluripotent Stem Cells were generated [ Time Frame: 5 years ]
- Number of stem cell lines for which the immune response was characterised [ Time Frame: 5 years ]
- Number of immunomodulatory therapies characterised [ Time Frame: 5 years ]
- Levels of baseline and stimulated gut hormones detected [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469207
|Contact: Kourosh Saeb-Parsy, PhD, FRCS||(+44 1223 7) email@example.com|
|Contact: Nikitas Georgakopoulos, BScfirstname.lastname@example.org|
|Cambridge, United Kingdom, CB2 0QQ|
|Contact: Andrew Bradley, PhD, FRCS (3)36976 (7)62001 email@example.com|
|Principal Investigator:||Kourosh Saeb-Parsy, PhD, FRCS||Cambridge Univeristy Hospitals|