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

NCT ID: NCT01967186

Last Updated: 2015-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2016-07-31

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.

Conditions

Type 1 Diabetes; End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intraportal islet transplantation

Subject randomized to the protocol with intraportal islet transplantation and kidney transplantation

Group Type: EXPERIMENTAL

Intraportal islet transplantation

Intervention Type: PROCEDURE

Kidney transplantation

Intervention Type: PROCEDURE

All patients will undergo kidney transplantation regardless of arm

Intramuscular islet transplantation

Subject randomized to the protocol with intramuscular islet transplantation and kidney transplantation

Group Type: EXPERIMENTAL

Intramuscular islet transplantation

Intervention Type: PROCEDURE

Kidney transplantation

Intervention Type: PROCEDURE

All patients will undergo kidney transplantation regardless of arm

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

Group Type: EXPERIMENTAL

Intramuscular transpl with stemcells

Intervention Type: PROCEDURE

Kidney transplantation

Intervention Type: PROCEDURE

All patients will undergo kidney transplantation regardless of arm

Kidney transplantation only

Subject that only undergoes kidney transplantation

Group Type: ACTIVE_COMPARATOR

Kidney transplantation

Intervention Type: PROCEDURE

All patients will undergo kidney transplantation regardless of arm

Interventions

Intraportal islet transplantation

Intervention Type: PROCEDURE

Intramuscular islet transplantation

Intervention Type: PROCEDURE

Intramuscular transpl with stemcells

Intervention Type: PROCEDURE

Kidney transplantation

All patients will undergo kidney transplantation regardless of arm

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Nordic Network For Clinical Islet Transplantation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kaija Salmela, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Kidney Transplant Unit, Helsinki University Hospital, Helsinki, Finland

Other Identifiers

SIK01

Identifier Type: -

Identifier Source: org_study_id