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

The Nordic Network For Clinical Islet Transplantation

Status: Unknown

Conditions: Type 1 Diabetes; End Stage Renal Disease

Treatments: Procedure: Intramuscular transpl with stemcells; Procedure: Intraportal islet transplantation; Procedure: Kidney transplantation; Procedure: Intramuscular islet transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01967186

SIK01

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

Intraportal islet transplantation

Experimental group

Description:

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

Treatment:

Procedure: Intraportal islet transplantation

Procedure: Kidney transplantation

Intramuscular islet transplantation

Experimental group

Description:

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

Treatment:

Procedure: Intramuscular islet transplantation

Procedure: Kidney transplantation

Intramuscular transpl with stemcells

Experimental group

Description:

Subject randomized to the protocol with intramuscular islet transplantation and where islets have been incubated autologous mesenchymal stemcells. Will also receive kidney transplant

Treatment:

Procedure: Intramuscular transpl with stemcells

Procedure: Kidney transplantation

Kidney transplantation only

Active Comparator group

Description:

Subject that only undergoes kidney transplantation

Treatment:

Procedure: Kidney transplantation