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

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ClinicalTrials.gov Identifier: NCT02469207
Recruitment Status : Unknown
Verified July 2016 by Dr. Kourosh Saeb-Parsy, Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : June 11, 2015
Last Update Posted : July 14, 2016
Sponsor:
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
Information provided by (Responsible Party):
Dr. Kourosh Saeb-Parsy, Cambridge University Hospitals NHS Foundation Trust

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).

Condition or disease Intervention/treatment
Graft Rejection Transplantation Diabetes Mellitus Other: Removal of tissue post-mortem

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study Utilising Tissue From Deceased Organ Donors to Investigate Regenerative Cellular Therapies and Related Physiological and Developmental Processes
Study Start Date : January 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

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



Primary Outcome Measures :
  1. Number of donors from which induced Pluripotent Stem Cells were generated [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Number of stem cell lines for which the immune response was characterised [ Time Frame: 5 years ]
  2. Number of immunomodulatory therapies characterised [ Time Frame: 5 years ]
  3. Levels of baseline and stimulated gut hormones detected [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
DNA data from tissue samples from donated organs may be retained anonymously for a period up to 10 years


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 92 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All deceased organ donors for whom informed consent is available from the donor family
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Donors aged <16

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469207


Contacts
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Contact: Kourosh Saeb-Parsy, PhD, FRCS (+44 1223 7) 68456 ks10014@cam.ac.uk
Contact: Nikitas Georgakopoulos, BSc +447554003700 georgakopoulosn@yahoo.com

Locations
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United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Andrew Bradley, PhD, FRCS    (3)36976 (7)62001    jab52@cam.ac.uk   
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
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
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Principal Investigator: Kourosh Saeb-Parsy, PhD, FRCS Cambridge Univeristy Hospitals
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Responsible Party: Dr. Kourosh Saeb-Parsy, Mr Kourosh Saeb-Parsy, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02469207    
Other Study ID Numbers: A093532
15/EE/0152 ( Other Identifier: Research Ethics Committee )
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Keywords provided by Dr. Kourosh Saeb-Parsy, Cambridge University Hospitals NHS Foundation Trust:
regenerative medicine
stem cells
immunomodulatory
induced pluripotent stem cells
gut physiology