Regenerative Cellular Therapies, Physiology, Pathology and Developmental Biology

Diabetes Mellitus Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02469207
• Other study ID #: A093532
• Secondary ID: 15/EE/0152
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2015
• Last updated: July 13, 2016
• Start date: January 2016
• Est. completion date: June 2020

Study information

• Verified date: July 2016
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Kourosh Saeb-Parsy, PhD, FRCS
• Phone: (+44 1223 7) 68456
• Email: ks10014[@]cam.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 92 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Donors aged <16

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Graft Rejection
• Transplantation

Intervention

Other:
• Removal of tissue post-mortem

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge

Sponsors (8)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	Anne McLarent Laboratory of Regenerative Medicine, Cambridge, Cambridge Stem Cell Institute, Cambridge, Institute of Metabolic Science, Cambridge, MRC Mitochondrial Biology Unit, Cambridge, Sanger Institure, Cambridge, The Gurdon Institute, Cambridge, University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of donors from which induced Pluripotent Stem Cells were generated		5 years	No
Secondary	Number of stem cell lines for which the immune response was characterised		5 years	No
Secondary	Number of immunomodulatory therapies characterised		5 years	No
Secondary	Levels of baseline and stimulated gut hormones detected		5 years	No