Clinical trial NCT01967186: Intraportal or Intramuscular Site for Islets in Simultaneous Islet and Kidney Transplantation
Official title: Open Multi-Center Randomized Study to Compare Safety and Efficacy of Islet Transplantation Using The Intraportal or Intramuscular Site in Simultaneous Islet and Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
End Stage Renal Disease
Keywords: Type 1 diabetes
islets
transplantation
nephropathy
intramuscular
Lead sponsor: The Nordic Network For Clinical Islet Transplantation
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: C-peptide derived from the Mixed Meal Tolerance Test (MMTT)
timeFrame: 365 days (+/-14) after kidney transplantation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kidney Transplant Unit, Helsinki University Hospital, Helsinki, Finland
name: Kaija Salmela, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: