- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02469207
Regenerative Cellular Therapies, Physiology, Pathology and Developmental Biology (RCT)
A Study Utilising Tissue From Deceased Organ Donors to Investigate Regenerative Cellular Therapies and Related Physiological and Developmental Processes
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Kourosh Saeb-Parsy, PhD, FRCS
- Phone Number: (+44 1223 7) 68456
- Email: ks10014@cam.ac.uk
Study Contact Backup
- Name: Nikitas Georgakopoulos, BSc
- Phone Number: +447554003700
- Email: georgakopoulosn@yahoo.com
Study Locations
-
-
-
Cambridge, United Kingdom, CB2 0QQ
- Recruiting
- Addenbrooke's Hospital
-
Contact:
- Andrew Bradley, PhD, FRCS
- Phone Number: (3)36976 (7)62001
- Email: jab52@cam.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All deceased organ donors with informed consent from the donor family
Exclusion Criteria:
- Donors aged <16
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of donors from which induced Pluripotent Stem Cells were generated
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of stem cell lines for which the immune response was characterised
Time Frame: 5 years
|
5 years
|
Number of immunomodulatory therapies characterised
Time Frame: 5 years
|
5 years
|
Levels of baseline and stimulated gut hormones detected
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kourosh Saeb-Parsy, PhD, FRCS, Cambridge Univeristy Hospitals
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- A093532
- 15/EE/0152 (Other Identifier: Research Ethics Committee)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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