Type1diabetesNCT04820270
Infusion of Autologous T Regulatory Cells (T Reg) at the Time of Transplantation of Allogenic Islets of Langerhans
A study testing Autologous T regulatory cells in people with Type1diabetes, run by The Nordic Network For Clinical Islet Transplantation at 2 sites in Sweden.
Trial summary
Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Autologous T regulatory cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesSweden
- Study dates
- 20 Aug 2018to 31 Jul 2021
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be registered on the waiting list within The Nordic Network for Clinical Islet Transplantation
- Type 1 diabetes with diagnosed <40years of age and with>5 years of exogenous insulin use
- C peptide < 0.1 nmol/L at MMTT if no previous islet transplant
- Adequate previous treatment by an experienced diabetologist
- Patient must understand and be able to sign an informed consent
Who cannot join
- Patient with a previous transplant other than islets
- Patient with an BMI>30
- Patient with an need of more than 1U/kg of insulin per 24h
- Repeated abnormal liver function tests
- non stable retinopathy
- known abnormalities in coagulation
Show all 14Show fewer
- known malignancies
- non stable heart conditions
- active infections
- serological proof of hepatitis B or C or HIV
- signs of portal hypertension
- patients that are pregnant, breast feeding or aim to become pregnant during the study period
- patients with a PRA > 20%, positive cross match or known DSA
- patients with conditions that the investigator would consider unsafe to combine with islet transplantation
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska University Hospital
Stockholm, 14186
Uppsala University Hospital
Uppsala
About this study
Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation.
Read the detailed description
Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation. Patients are recruited from the waiting list for islet transplantation within The Nordic Network for Clinical Islet Transplantation. Patients included in the study will undergo apheresis while on the waiting list. T regulatory cells will be sorted out and frozen. Autologous, non modified T regs will then be infused simultaneously intraportally with the islet graft at transplantation. Patients will be followed for safety and efficacy regarding the islet transplantation over three months
- Conditions
- Type1diabetes
- Being tested
- Autologous T regulatory cells
- Keywords
- Transplantation, Islets of Langerhans, T regulatory Cells (autologous)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous T regulatory cellsOther
Enriched autologous T regulatory cells are given back to the patient at the time of islet transplantation
| Study group | Role | What they receive |
|---|---|---|
| Autologous Tregs in allogenic islet transplantation | Experimental | Autologous Tregs are given simultaneously to the patient with the islets Receives: Other: Autologous T regulatory cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
Number of patients with >20g/L reduction of haemoglobine and signs of bleeding shown by ultrasound post operative day 1
Measured: 0-1 days post transplant
Thrombosis
Number of patients with thrombosis in portal veins shown by ultrasound post operative day 1 or later
Measured: 0-75 days post transplant
Liver function
Number of patients with an elevation of transaminases > 5 times upper normal level during follow up
Measured: 0-75days
Infections
Number of treatment requiering infections in each patient during follow up
Measured: 0-90 days post transplantation
Islet graft failure
Number of patients with islet graft failure shown as C peptide <0.1 nmol/L fasting or <0.3 nmol/L (90min) at a MMTT day 75 or lack of improvement compared to baseline if transplanted before.
Measured: day 75
Immunization
Number of patients with new anti HLA antibodies found at 90 days post transplantation compared to baseline
Measured: 90 days post transplantation
Secondary outcomes (6)
Islet function
Fraction of patients with a C-peptide level above 0.1 nmol/L fasting or 0.3 nmol/L (90min) at a MMTT day 75
Measured: day 75
Insulin independence
Fraction of patients without need of exogeous insulin (ADA criteria) at day 75 post transplantation
Measured: day 75
HbA1c
Mean reduction of HbA1c at day 75 compared to baseline(%)
Measured: day 75
Hypoglycemic unawareness
Number of patients with a reduced Clarke hypoglycemia awareness score day 75 (+/-5) post transplantation compared to baseline
Measured: day 75
HbA1c and hypoglycemic unawareness combined
Number of patients with both a HbA1c ≤ 6.5% (DCCT) and lack of severe hypoglycemia at day 75 post transplantation
Measured: day 75
PRA level
Number of patients with a rise in PRA (panel reactive antibodies) with more than 10% at 90 days post transplantation
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start20 Aug 2018
- Primary completion30 Apr 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm feasibility and safety study
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Nordic Network For Clinical Islet Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torbjörn Lundgren, MD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820270
- Sponsor's protocol ID
- AutoTregIsl
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusion of Autologous T Regulatory Cells (T Reg) at the Time of Transplantation of Allogenic Islets of Langerhans
- ClinicalTrials.gov ID
- NCT04820270
- Acronym / sponsor ID
- AutoTregIsl
- Conditions
- Type1diabetes
- Keywords
- Transplantation, Islets of Langerhans, T regulatory Cells (autologous)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- The Nordic Network For Clinical Islet TransplantationUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 29 Mar 2021 (actual)
- 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.
Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation.
Detailed description
Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation. Patients are recruited from the waiting list for islet transplantation within The Nordic Network for Clinical Islet Transplantation. Patients included in the study will undergo apheresis while on the waiting list. T regulatory cells will be sorted out and frozen. Autologous, non modified T regs will then be infused simultaneously intraportally with the islet graft at transplantation. Patients will be followed for safety and efficacy regarding the islet transplantation over three months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm feasibility and safety study
| Arm | Type | Receives |
|---|---|---|
| Autologous Tregs in allogenic islet transplantation | Experimental | Other: Autologous T regulatory cellsAutologous Tregs are given simultaneously to the patient with the islets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient must be registered on the waiting list within The Nordic Network for Clinical Islet Transplantation
- Type 1 diabetes with diagnosed <40years of age and with>5 years of exogenous insulin use
- C peptide < 0.1 nmol/L at MMTT if no previous islet transplant
- Adequate previous treatment by an experienced diabetologist
- Patient must understand and be able to sign an informed consent
Key exclusion criteria (14 listed)
- Patient with a previous transplant other than islets
- Patient with an BMI>30
- Patient with an need of more than 1U/kg of insulin per 24h
- Repeated abnormal liver function tests
- non stable retinopathy
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 |
|---|---|---|
| Autologous T regulatory cellsEnriched autologous T regulatory cells are given back to the patient at the time of islet transplantation | Other | Autologous Tregs in allogenic islet transplantation |
Primary outcome
Bleeding
Time frame: 0-1 days post transplant
Number of patients with >20g/L reduction of haemoglobine and signs of bleeding shown by ultrasound post operative day 1
Thrombosis
Time frame: 0-75 days post transplant
Number of patients with thrombosis in portal veins shown by ultrasound post operative day 1 or later
Liver function
Time frame: 0-75days
Number of patients with an elevation of transaminases > 5 times upper normal level during follow up
Infections
Time frame: 0-90 days post transplantation
Number of treatment requiering infections in each patient during follow up
Islet graft failure
Time frame: day 75
Number of patients with islet graft failure shown as C peptide <0.1 nmol/L fasting or <0.3 nmol/L (90min) at a MMTT day 75 or lack of improvement compared to baseline if transplanted before.
Immunization
Time frame: 90 days post transplantation
Number of patients with new anti HLA antibodies found at 90 days post transplantation compared to baseline
6 secondary outcomes
Islet function
Time frame: day 75
Insulin independence
Time frame: day 75
HbA1c
Time frame: day 75
Hypoglycemic unawareness
Time frame: day 75
HbA1c and hypoglycemic unawareness combined
Time frame: day 75
PRA level
Time frame: day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
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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.
Torbjörn Lundgren, MD principal investigator
Karolinska University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous T regulatory cells in people with Type1diabetes, run by The Nordic Network For Clinical Islet Transplantation at 2 sites in Sweden.
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 5 inclusion and 14 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 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: 0-1 days post transplant). The study lists 6 primary outcomes in all. 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 29 Mar 2021.