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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01967186
• Other study ID #: SIK01
• Status: Active, not recruiting
• Phase: N/A
• First received: October 16, 2013
• Last updated: October 5, 2015
• Start date: April 2007
• Est. completion date: July 2016

Study information

• Verified date: October 2015
• Source: The Nordic Network For Clinical Islet Transplantation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• End Stage Renal Disease
• Kidney Failure, Chronic
• Type 1 Diabetes

Intervention

Procedure:
• Intraportal islet transplantation

• Intramuscular islet transplantation

• Intramuscular transpl with stemcells

• Kidney transplantation
All patients will undergo kidney transplantation regardless of arm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Nordic Network For Clinical Islet Transplantation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No