Clinical trial NCT02469207: Regenerative Cellular Therapies, Physiology, Pathology and Developmental Biology
Official title: A Study Utilising Tissue From Deceased Organ Donors to Investigate Regenerative Cellular Therapies and Related Physiological and Developmental Processes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Graft Rejection
Transplantation
Diabetes Mellitus
Keywords: regenerative medicine
stem cells
immunomodulatory
induced pluripotent stem cells
gut physiology
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
name: Cambridge Stem Cell Institute, Cambridge
name: Anne McLarent Laboratory of Regenerative Medicine, Cambridge
name: The Gurdon Institute, Cambridge
name: Sanger Institure, Cambridge
name: Institute of Metabolic Science, Cambridge
name: MRC Mitochondrial Biology Unit, Cambridge
First posted: 2015-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 92
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All deceased organ donors for whom informed consent is available from the donor family

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Donors aged \<16

Primary outcomes:
measure: Number of donors from which induced Pluripotent Stem Cells were generated
timeFrame: 5 years
Secondary outcomes:
measure: Number of stem cell lines for which the immune response was characterised
timeFrame: 5 years
measure: Number of immunomodulatory therapies characterised
timeFrame: 5 years
measure: Levels of baseline and stimulated gut hormones detected
timeFrame: 5 years
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
Study officials:
affiliation: Cambridge Univeristy Hospitals
name: Kourosh Saeb-Parsy, PhD, FRCS
role: PRINCIPAL_INVESTIGATOR
References: