Graft RejectionRCTNCT02469207
Regenerative Cellular Therapies, Physiology, Pathology and Developmental Biology
An observational study of Graft Rejection and Transplantation, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 92 yearsHealthy volunteers can take part
- Conditions the study is for
- Graft Rejection, Transplantation, Diabetes Mellitus
- What is being tested?
- Removal of tissue post-mortem
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 92 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All deceased organ donors for whom informed consent is available from the donor family
Who may be able to join
- All deceased organ donors with informed consent from the donor family
Who cannot join
- Donors aged <16
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Andrew Bradley, PhD, FRCS, (3)36976 (7)62001, jab52@cam.ac.uk
About this study
Official title: A Study Utilising Tissue From Deceased Organ Donors to Investigate Regenerative Cellular Therapies and Related Physiological and Developmental Processes
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).
Read the 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.
- Conditions
- Graft Rejection, Transplantation, Diabetes Mellitus
- Being tested
- Removal of tissue post-mortem
- Keywords
- regenerative medicine, stem cells, immunomodulatory, induced pluripotent stem cells, gut physiology
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of tissue post-mortemOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Removal of tissue post-mortem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of donors from which induced Pluripotent Stem Cells were generated
Measured: 5 years
Secondary outcomes (3)
Number of stem cell lines for which the immune response was characterised
Measured: 5 years
Number of immunomodulatory therapies characterised
Measured: 5 years
Levels of baseline and stimulated gut hormones detected
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Dr. Kourosh Saeb-Parsy, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Kourosh Saeb-Parsy, PhD, FRCS, Principal investigator, Cambridge Univeristy Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469207
- Sponsor's protocol ID
- A093532
- Other IDs
- 15/EE/0152
- Acronym
- RCT
- Status last verified
- Jul 2016
- First submitted
- 9 Jun 2015
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Utilising Tissue From Deceased Organ Donors to Investigate Regenerative Cellular Therapies and Related Physiological and Developmental Processes
- ClinicalTrials.gov ID
- NCT02469207
- Acronym / sponsor ID
- RCT / A093532
- Conditions
- Graft Rejection, Transplantation, Diabetes Mellitus
- Keywords
- regenerative medicine, stem cells, immunomodulatory, induced pluripotent stem cells, gut physiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- 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
- Study start
- Jan 2016
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deceased organ donors | – | Other: Removal of tissue post-mortemPatients 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. |
Who may qualify
- Ages
- 16 to 92 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All deceased organ donors for whom informed consent is available from the donor family
Key inclusion criteria (1 listed)
- All deceased organ donors with informed consent from the donor family
Key exclusion criteria (1 listed)
- Donors aged <16
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removal of tissue post-mortem | Other | Deceased organ donors |
Primary outcome
Number of donors from which induced Pluripotent Stem Cells were generated
Time frame: 5 years
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
Related trials for Graft Rejection
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Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
Enrolling by invitationPhase 3
A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)
Antibody-mediated Rejection, Microvascular Inflammation
Not yet recruiting
Molecular Evidence of Rejection Intervention Trial
Heart Transplant Rejection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kourosh Saeb-Parsy, PhD, FRCS principal investigator
Cambridge Univeristy Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Rejection and Transplantation, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kourosh Saeb-Parsy, PhD, FRCS ((+44 1223 7) 68456, ks10014@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of donors from which induced Pluripotent Stem Cells were generated (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.