NCT01967186

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: The Nordic Network For Clinical Islet Transplantation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Type 1 Diabetes
• End Stage Renal Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-04-01
• Primary completion: 2016-01-01
• Completion: 2016-07-01
• First posted: 2013-10-22
• Last updated: 2015-10-06