Regenerative Cellular Therapies, Physiology, Pathology and Developmental Biology

• Conditions: Transplantation; Diabetes Mellitus; Graft Rejection
• Interventions: Other: Removal of tissue post-mortem

• Registration Number: NCT02469207
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

This study aims to use tissue from deceased organ donors to investigate organ physiology, developmental biology, as well as the development of future regenerative cellular therapies. It will investigate function and immune response to stem cells as well as their generation from adult cells and generation of induced pluripotent stem cells (iPSCs).

Detailed Description

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 Timeline

• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-11
• Study Start: 2016-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All deceased organ donors with informed consent from the donor family

Exclusion Criteria

• Donors aged <16

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Deceased organ donors	Removal of tissue post-mortem	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.

Primary Outcome Measures

Name	Time	Method
Number of donors from which induced Pluripotent Stem Cells were generated	5 years

Secondary Outcome Measures

Name	Time	Method
Number of immunomodulatory therapies characterised	5 years
Number of stem cell lines for which the immune response was characterised	5 years
Levels of baseline and stimulated gut hormones detected	5 years

Trial Locations

Locations (1)

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom