Bone Marrow as an Alternative Site for Islet Transplantation

Study Overview
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Brief Summary
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The goal of this study is to evaluate safety and feasibility of bone marrow (BM) as site for islet transplantation (Tx) in humans. The investigators hypothesis is that BM represents a better site than liver thanks to its potential capacity to favor islet engraftment in face of a more easiness of access and bioptic follow up.

Detailed Description
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We were permitted to perform single intra BM islet infusion at the level of the iliac crest in patients having contraindications for intraportal infusion. A needle for BM aspiration (14 G) is inserted into the superior-posterior iliac crest and islet suspension (1:2.5; tissue:Ringer's Lactate solution) is infused. The entire intraBM-injection procedure lasted 8-15 min from the beginning of anaesthesia (short propofol sedation).

Official Title
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Pilot Study to Assess Feasibility and Safety of Bone Marrow as Alternative Site in Islet Transplant Patients

Conditions
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Type 1 Diabetes, Postpancreatectomy Hyperglycemia

Intervention / Treatment
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* Procedure: Intra bone marrow islet infusion


Participation Criteria
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Eligibility Criteria
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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 patients undergoing total pancreatectomy because of anastomosis leakage after pancreatoduodenectomy or because of pancreatic anastomosis is made impracticable by technical difficulties and/or high risk of leakage. presence of contraindications for intraportal islet infusion Exclusion Criteria: presence of hematologic disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra BM islet infusion<br>single intra BM islet infusion at the level of the iliac crest will be performed in patients having contraindications for intraportal infusion | Procedure: Intra bone marrow islet infusion<br>* A needle for bone marrow aspiration (14 G) will be inserted into the superior-posterior iliac crest and islet suspension (1:2.5; tissue:Ringer's Lactate solution) will be infused. The entire intraBM-injection procedure last 8-15 min from the beginning of anaesthesia (short propofol sedation).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events related to the procedure of intra bone marrow islet infusion |  | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta-cell function | Beta-cell function will be assessed by fasting C peptide, HbA1c,glycaemia, change in average daily insulin requirements, basal (fasting) and -10 to 120 min time course of glucose, C-peptide and insulin derived from the arginine test, beta-score and Transplant Estimated Function | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, islet transplantation, autotransplantation