AzTrials
AzTrials

Patients With Type 1 DiabetesPhase 2GRIIFNCT01974674

Allogeneic Islet Transplantation for the Treatment of Type 1 Diabetes

A Phase 2 study testing Allogeneic transplantation of intrahepatic islet in people with Patients With Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

It is a multicentre, sequential, phase II clinical trial, aiming at evaluating the allogeneic islet transplantation for the treatment of type 1 diabetes. 19 patients with type 1 diabetes will be included and ideally distributed evenly: patients with unstable diabetes without renal insufficiency (AI group for "islet… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Patients With Type 1 Diabetes
What is being tested?
Allogeneic transplantation of intrahepatic islet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteFrance
Study dates
Jul 2013to Jan 2022
Phase
Phase 2
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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with type 1 diabetes
  • 18 <Age <55 years
  • Plasma C-peptide <0.2 ng/ml basal and stimulated glucagon
  • Evolution of diabetes for more than 5 years
  • Regular patient follow-up (> or equal to 2 visits per year from the same diabetologist)
  • Patient who received the information and have given their consent in writing
Show all 22Show fewer
  • Absence of HIV, hepatitis B and hepatitis C, HTLV-1-2
  • ABO compatibility with the donor
  • Cross match negative
  • Anti-HLA antibodies (class I and / or class II) detected by lymphocytotoxicity <20%
  • PCR negative for the BK virus in the blood (so as not to amplify the BK virus replication with the ATG).
  • Accepting patients effective contraception during the study period
  • For patients in group IA
  • Glomerular filtration rate estimated by the MDRD> 50 ml/min/1.73m2
  • No perception of hypoglycaemia (less than 0.54 mg/dl glucose) at least one value documented in the two years preceding and/or
  • Occurrence of at least one severe hypoglycemic episode (with a third required) and unexplained in the two years before and/or at least two episodes of ketoacidosis per year
  • Average HbA1c> 8.5% over two years, despite intensified treatment (basal pattern, bolus)
  • For patients in the IAK
  • functional renal graft for at least 1 year
  • glomerular filtration rate> 50 ml/min/1.73 m2
  • proteinuria <0.5 g/day
  • Absence of acute rejection in renal previous 6 months

Who cannot join

  • BMI > 28
  • Need insulin > 1 U/kg per day
  • Pregnancy, lactation
  • Intention of childbearing for the two sexes
  • Psychiatric Disorders
  • Inability to communicate or cooperate with the investigator
Show all 21Show fewer
  • Lack of therapeutic compliance, including HbA1C > 12%
  • Chronic liver disease
  • Progressive heart disease myocardial infarction within 6 months prior to inclusion, unbalanced CHD)
  • Proliferative retinopathy unstabilized
  • History of cancer, whatever the date, except for basal or squamous cell skin cancers over 1 year.
  • Systemic infection
  • Chronic high risk of requiring corticosteroids
  • Need for long-term corticosteroid, outside that specified in renal transplantation, the patients will be weaned before transplantation
  • Anticoagulant vitamin K or antiplatelet treatments
  • Disorders of hemostasis TP <60 % TCA > 1.5 times the control
  • Anti-HLA antibodies ( class I and/or class II ) detected by lymphocytotoxicity > 20%
  • Platelets < 100 giga/L and/or neutrophils <1.5 giga/L
  • Chronic intoxication by alcohol, tobacco, or other substance (abstinence > 6 months required)
  • Active infection by hepatitis B, hepatitis C and HIV, HTLV-1-HTLV2
  • Ascites

Trial locations and contacts

1 site in 1 country.

Pierre CATTAN, MD PhD contact

33 1 42494786

pierre.cattan@sls.aphp.fr

France1 site, 1 recruiting

  • Saint Louis hospital

    Paris, Île-de-France Region, 75010

    Pierre CATTAN, MD PhD, 33 1 42494786, pierre.cattan@sls.aphp.fr

    Recruiting

Other trials in France

About this study

It is a multicentre, sequential, phase II clinical trial, aiming at evaluating the allogeneic islet transplantation for the treatment of type 1 diabetes.

19 patients with type 1 diabetes will be included and ideally distributed evenly: patients with unstable diabetes without renal insufficiency (AI group for "islet alone" by the international customary determination) and patients with a functioning kidney transplant (IAK group for "islet after kidney"). The main endpoint will be defined by the restoration of normal glycemic control without insulin at 6 months after graft.

Being tested
Allogeneic transplantation of intrahepatic islet
Keywords
diabetes, transplantation
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogeneic transplantation of intrahepatic isletProcedure or surgery

Study groups in NCT01974674
Study groupRoleWhat they receive
Allogeneic transplantation of intrahepatic isletExperimentalAllogeneic transplantation of intrahepatic islet number required for insulin independence of obtaining, with a threshold dose of 9,000 IEQ/kg body weight of the recipient and a maximum sequence number of 3 infusions. The patient will receive after transplantation immunosuppressive therapy with Thymoglobulin for induction, Prograf and Cellcept, both of which are given throughout the duration of the study
Receives: Procedure: Allogeneic transplantation of intrahepatic islet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. restoration of normal glycemic control without insulin

    the restoration of normal glycemic control without insulin therapy will be evaluated by measuring

    • A fasting glucose (> 8 hours) less than 1.25 g/L and a 2 hours glucose after oral intake of 75g of glucose, less than 2 g/L in a patient without insulin for at least 15 consecutive days during the the first 6 months from day 0.

    Measured: 6 months after graft

Secondary outcomes (12)

  1. Restoration of normal glycemic control without insulin for a year

    Measured: 1 year

  2. Obtaining an improvement in glycemic control

    HbA1c <6.5%, with lower insulin doses by 30%

    Measured: within 2 years after inclusion

  3. Obtaining a remission of diabetes

    The remission of diabetes is defined by the normality of blood glucose or insulin without lHbA1c.

    The normality of blood glucose is defined below 1.20 g/L and postprandial fasting glycemia less than 1.60 g/L in the book self-monitoring (including 6/7 blood glucoses during the previous 3 days evaluation visit).

    Normal HbA1c is defined as less than 6.5%.

    Measured: within 2 years after inclusion

  4. Improved metabolic profile determined by the OGTT and hyperglycemic clamp

    Measured: within 2 years after inclusion

  5. Decreased glycemic variability

    defined on blood glucose and / or glucose holter

    Measured: within 2 years after inclusion

  6. Reduction of oxidative stress assessed by the urinary excretion of 24 hours of 8-iso-PGF2 rates.

    Measured: within 2 years after inclusion

  7. Decrease in the frequency, severity or poor perception of hypoglycaemia defined Hypo score

    Measured: within the 2 years after inclusion

  8. quality of life

    defined by questionnaires DQOL and SF-36

    Measured: within 2 years after inclusion

  9. term graft survival

    defined by the rate of C-peptide

    Measured: within 2 years of inclusion

  10. beta-cell function

    based on beta-score

    Measured: 2 years

  11. potential of each infusion of islets

    number of IEQ/kg of recipient required to reduce the daily insulin dose of 1 unit

    Measured: within 2 years after inclusion

  12. degenerative complications of diabetes

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionDec 2016 (estimated)
  4. Study completionJan 2022 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01974674
Sponsor's protocol ID
P030415
Acronym
GRIIF
Status last verified
Sep 2016
First submitted
28 Oct 2013
Last updated
29 Sep 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Allogeneic transplantation of intrahepatic islet in people with Patients With Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 22 inclusion and 21 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 Sep 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 France. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Pierre CATTAN, MD PhD (33 1 42494786, pierre.cattan@sls.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

restoration of normal glycemic control without insulin (time frame: 6 months after graft). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01974674.

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 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in