Regenerative Cellular Therapies, Physiology, Pathology and Developmental Biology

Study Overview
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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.

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

Conditions
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Graft Rejection, Transplantation, Diabetes Mellitus

Intervention / Treatment
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* Other: Removal of tissue post-mortem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All deceased organ donors with informed consent from the donor family Exclusion Criteria: Donors aged <16

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 92 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Deceased organ donors<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regenerative medicine, stem cells, immunomodulatory, induced pluripotent stem cells, gut physiology