Regenerative Cellular Therapies, Physiology, Pathology and Developmental Biology (RCT)

July 13, 2016 updated by: Dr. Kourosh Saeb-Parsy, Cambridge University Hospitals NHS Foundation Trust

A Study Utilising Tissue From Deceased Organ Donors to Investigate Regenerative Cellular Therapies and Related Physiological and Developmental Processes

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Addenbrooke's Hospital
        • Contact:
          • Andrew Bradley, PhD, FRCS
          • Phone Number: (3)36976 (7)62001
          • Email: jab52@cam.ac.uk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 92 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All deceased organ donors for whom informed consent is available from the donor family

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Donors aged <16

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of donors from which induced Pluripotent Stem Cells were generated
Time Frame: 5 years
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

University of Cambridge
Cambridge Stem Cell Institute, Cambridge
Anne McLarent Laboratory of Regenerative Medicine, Cambridge
The Gurdon Institute, Cambridge
Sanger Institure, Cambridge
Institute of Metabolic Science, Cambridge
MRC Mitochondrial Biology Unit, Cambridge

Investigators

  • Principal Investigator: Kourosh Saeb-Parsy, PhD, FRCS, Cambridge Univeristy Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 11, 2015

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A093532
  • 15/EE/0152 (Other Identifier: Research Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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