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

NCT01967186 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-10-06

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Intraportal islet transplantation

PROCEDURE

Intramuscular islet transplantation

PROCEDURE

Intramuscular transpl with stemcells

PROCEDURE

Kidney transplantation

All patients will undergo kidney transplantation regardless of arm

Sponsors & Collaborators

  • The Nordic Network For Clinical Islet Transplantation

    lead OTHER

Principal Investigators

  • Kaija Salmela, MD PhD · Kidney Transplant Unit, Helsinki University Hospital, Helsinki, Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2016-01-31
Completion
2016-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01967186 on ClinicalTrials.gov