Regenerative Cellular Therapies, Physiology, Pathology and Developmental Biology

NCT ID: NCT02469207

Last Updated: 2016-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Graft Rejection Transplantation Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Removal of tissue post-mortem

Intervention Type OTHER

Interventions

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Removal of tissue post-mortem

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Donors aged \<16
Minimum Eligible Age

16 Years

Maximum Eligible Age

92 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cambridge

OTHER

Sponsor Role collaborator

Cambridge Stem Cell Institute, Cambridge

UNKNOWN

Sponsor Role collaborator

Anne McLarent Laboratory of Regenerative Medicine, Cambridge

UNKNOWN

Sponsor Role collaborator

The Gurdon Institute, Cambridge

UNKNOWN

Sponsor Role collaborator

Sanger Institure, Cambridge

UNKNOWN

Sponsor Role collaborator

Institute of Metabolic Science, Cambridge

UNKNOWN

Sponsor Role collaborator

MRC Mitochondrial Biology Unit, Cambridge

UNKNOWN

Sponsor Role collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Dr. Kourosh Saeb-Parsy

Mr Kourosh Saeb-Parsy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kourosh Saeb-Parsy, PhD, FRCS

Role: PRINCIPAL_INVESTIGATOR

Cambridge Univeristy Hospitals

Locations

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Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Kourosh Saeb-Parsy, PhD, FRCS

Role: CONTACT

(+44 1223 7) 68456

Nikitas Georgakopoulos, BSc

Role: CONTACT

+447554003700

Facility Contacts

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Andrew Bradley, PhD, FRCS

Role: primary

(3)36976 (7)62001

Other Identifiers

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15/EE/0152

Identifier Type: OTHER

Identifier Source: secondary_id

A093532

Identifier Type: -

Identifier Source: org_study_id

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