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NCT Number: NCT01722682

Bone Marrow vs Liver as Site for Islet Transplantation

The goal of this study is to evaluate safety and efficacy of bone marrow (BM) as site for pancreatic islet transplantationin humans. Our hypothesis is that BM represents a better site than liver (currently the location of choice for this procedure) thanks to its potential capacity to favor islet engraftment. To address our hypothesis we propose herein a randomized phase II trial to compare BM and liver as sites for islet transplantation in T1D patients.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ospedale San Raffaele

Milan, 20132, Italy

About this study

The study is a phase II, single center, open label, pilot study. We will recruit 12 patients with T1D to be randomly (1:1) assigned to receive islet either into the liver through the portal venous circulation (standard procedure; arm A, n=6) or directly into the BM at the level of the iliac crest (arm B, n=6). Patients will be selected from those eligible for islet Tx based on local practice and guidelines.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diabetic patients eligible for pancreatic islet transplantation based on local accepted practice and guidelines. This includes at least: a)clinical history compatible with T1D with insulin-dependence for >5 years; b) undetectable stimulated (arginine or MMTT) C-peptide levels (<0.3 ng/mL) in the 12 months before transplant c)presence of severe hypoglycaemic events

Exclusion criteria

  • presence of hematologic disease

Treatment and study plan

Human Pancreatic Islet Transplantation

Biological

Primary outcomes

  1. Insulin secretion under stimulation

    Time frame: month 12 post-Tx

    basal and -10 to 120 min time course of glucose, C-pep levels and insulin derived from the mixed meal tolerance test

Secondary outcomes

  1. Incidence and severity of Adverse Events (AE) and Serious Adverse Events (SAE)

    Time frame: throughout the study up to 1 year after first transplant

  2. Insulin requirement

    Time frame: month 1, 3, 6, 9, 12 post- transplant

    Change in average daily insulin requirements

  3. Islet function

    Time frame: month 1, 3, 6, 9, 12 post-Tx

    change in HbA1c, Transplant Estimated Function (TEF) and fasting C-peptide levels

Sponsors and collaborators

Lead sponsor

Ospedale San Raffaele

Other

Collaborators

  • Ministry of Health, Italy

Registry information

Official study title

Bone Marrow vs Liver as Site for Islet Transplantation in Patients With Type 1 Diabetes: Pilot Study to Evaluate Efficacy

Acronym: IsletBOM2

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2012
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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