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Intraportal or Intramuscular Site for Islets in Simultaneous Islet and Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT01967186
Recruitment Status : Unknown
Verified October 2015 by The Nordic Network For Clinical Islet Transplantation.
Recruitment status was:  Active, not recruiting
First Posted : October 22, 2013
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
The Nordic Network For Clinical Islet Transplantation

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes End Stage Renal Disease Procedure: Intraportal islet transplantation Procedure: Intramuscular islet transplantation Procedure: Intramuscular transpl with stemcells Procedure: Kidney transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2007
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intraportal islet transplantation
Subject randomized to the protocol with intraportal islet transplantation and kidney transplantation
Procedure: Intraportal islet transplantation
Procedure: Kidney transplantation
All patients will undergo kidney transplantation regardless of arm

Experimental: Intramuscular islet transplantation
Subject randomized to the protocol with intramuscular islet transplantation and kidney transplantation
Procedure: Intramuscular islet transplantation
Procedure: Kidney transplantation
All patients will undergo kidney transplantation regardless of arm

Experimental: Intramuscular transpl with stemcells
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 stemcells
Procedure: Kidney transplantation
All patients will undergo kidney transplantation regardless of arm

Active Comparator: Kidney transplantation only
Subject that only undergoes kidney transplantation
Procedure: Kidney transplantation
All patients will undergo kidney transplantation regardless of arm




Primary Outcome Measures :
  1. C-peptide derived from the Mixed Meal Tolerance Test (MMTT) [ Time Frame: 365 days (+/-14) after kidney transplantation ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967186


Sponsors and Collaborators
The Nordic Network For Clinical Islet Transplantation
Investigators
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Principal Investigator: Kaija Salmela, MD PhD Kidney Transplant Unit, Helsinki University Hospital, Helsinki, Finland

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Responsible Party: The Nordic Network For Clinical Islet Transplantation
ClinicalTrials.gov Identifier: NCT01967186     History of Changes
Other Study ID Numbers: SIK01
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015

Keywords provided by The Nordic Network For Clinical Islet Transplantation:
Type 1 diabetes
islets
transplantation
nephropathy
intramuscular

Additional relevant MeSH terms:
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Kidney Failure, Chronic
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency