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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 9, 2015
First Posted Date June 11, 2015
Last Update Posted Date July 14, 2016
Study Start Date January 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2015)
Number of donors from which induced Pluripotent Stem Cells were generated [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 10, 2015)
  • Number of stem cell lines for which the immune response was characterised [ Time Frame: 5 years ]
  • Number of immunomodulatory therapies characterised [ Time Frame: 5 years ]
  • Levels of baseline and stimulated gut hormones detected [ Time Frame: 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Regenerative Cellular Therapies, Physiology, Pathology and Developmental Biology
Official Title A Study Utilising Tissue From Deceased Organ Donors to Investigate Regenerative Cellular Therapies and Related Physiological and Developmental Processes
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).
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA data from tissue samples from donated organs may be retained anonymously for a period up to 10 years
Sampling Method Non-Probability Sample
Study Population All deceased organ donors for whom informed consent is available from the donor family
Condition
  • Graft Rejection
  • Transplantation
  • Diabetes Mellitus
Intervention Other: Removal of tissue post-mortem
Study Groups/Cohorts 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.
Intervention: Other: Removal of tissue post-mortem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 10, 2015)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Donors aged <16
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 92 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02469207
Other Study ID Numbers A093532
15/EE/0152 ( Other Identifier: Research Ethics Committee )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Kourosh Saeb-Parsy, Cambridge University Hospitals NHS Foundation Trust
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
PRS Account Cambridge University Hospitals NHS Foundation Trust
Verification Date July 2016