NCT01967186

Brief Summary

Islet transplantation is a promising treatment of type 1 diabetes in selected cases. Results are however hampered by a relatively low number of islets surviving the transplantation into the liver, which currently is the site for transplantation. In the present study we compare a new transplantation site (intramuscular in the arm) to the golden standard (the liver) in patients undergoing kidney transplantation from the same donor. In half of the intramuscular transplanted patients, the islets will be mixed with mesenchymal stemcells from the recipient to, possibly, improve the immunological aspects of the transplantation.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 6, 2015

Status Verified

October 1, 2015

Enrollment Period

8.8 years

First QC Date

October 16, 2013

Last Update Submit

October 5, 2015

Conditions

Type 1 DiabetesEnd Stage Renal Disease

Keywords

Type 1 diabetesisletstransplantationnephropathyintramuscular

Outcome Measures

Primary Outcomes (1)

  • C-peptide derived from the Mixed Meal Tolerance Test (MMTT)

    Percentage of patients in each study group reaching a systemic C-peptide derived from the MMTT above 0.1 nmol/L basal (fasting) and 90-min 0.3 nmol/L 75 (+/-5) and 365 days (+/-14) after kidney transplantation

    365 days (+/-14) after kidney transplantation

Study Arms (4)

Intraportal islet transplantation

EXPERIMENTAL

Subject randomized to the protocol with intraportal islet transplantation and kidney transplantation

Procedure: Intraportal islet transplantationProcedure: Kidney transplantation

Intramuscular islet transplantation

EXPERIMENTAL

Subject randomized to the protocol with intramuscular islet transplantation and kidney transplantation

Procedure: Intramuscular islet transplantationProcedure: Kidney transplantation

Intramuscular transpl with stemcells

EXPERIMENTAL

Subject randomized to the protocol with intramuscular islet transplantation and where islets have been incubated autologous mesenchymal stemcells. Will also receive kidney transplant

Procedure: Intramuscular transpl with stemcellsProcedure: Kidney transplantation

Kidney transplantation only

ACTIVE COMPARATOR

Subject that only undergoes kidney transplantation

Procedure: Kidney transplantation

Interventions

Intraportal islet transplantationPROCEDURE
Intraportal islet transplantation
Intramuscular islet transplantationPROCEDURE
Intramuscular islet transplantation
Intramuscular transpl with stemcellsPROCEDURE
Intramuscular transpl with stemcells
Kidney transplantationPROCEDURE

All patients will undergo kidney transplantation regardless of arm

Intramuscular islet transplantationIntramuscular transpl with stemcellsIntraportal islet transplantationKidney transplantation only

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients age 18 to 65 years of age.
  • Ability to provide written informed consent.
  • Mentally stable and able to comply with the procedures of the study protocol.
  • Clinical history compatible with type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years at the time of enrolment.
  • Absence of stimulated C-peptide \<0.1 nmol/L in response to a MMTT.
  • All subjects must have received adequate medical treatment of their diabetes under the guidance from an experienced diabetologist.
  • All subjects must have renal failure and be eligible for renal transplantation according to local criteria.

You may not qualify if:

  • Patients with prior organ transplants
  • Patients that qualify for local simultaneous pancreas-kidney transplantation program and who prefer that option
  • Patients with body mass index BMI \> 28.
  • Insulin requirement \> 1 Unit/kg/day. If the patient is on peritoneal dialysis the same limit is set when the extra carbohydrates in the dialysis fluids have been accounted for.
  • Consistently abnormal liver function tests ( \> 1.5 x the upper limit of normal on two consecutive measurements \> 2 weeks apart)
  • Unstable diabetic retinopathy
  • Hypercoagulability disorder or coagulopathy or International normalized ratio (INR)\>1.5
  • Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
  • Patients with unstable cardiovascular status
  • Patients with active infections, unless treatment is not judged necessary by the investigators
  • Patients with serological evidence of infection with HIV, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Kidney Failure, ChronicKidney Diseases

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsOrgan TransplantationTransplantationSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Kaija Salmela, MD PhD

    Kidney Transplant Unit, Helsinki University Hospital, Helsinki, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 22, 2013

Study Start

April 1, 2007

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

October 6, 2015

Record last verified: 2015-10