Bone Marrow as an Alternative Site for Islet Transplantation

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Postpancreatectomy Hyperglycemia
• Interventions: Procedure: Intra bone marrow islet infusion

• Registration Number: NCT01345227
• Lead Sponsor: Ospedale San Raffaele

Brief Summary

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

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).

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2011-04
• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-05-02
• Study Completion: 2011-10
• Status Verified: 2012-10
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra BM islet infusion	Intra bone marrow islet infusion	single intra BM islet infusion at the level of the iliac crest will be performed in patients having contraindications for intraportal infusion

Primary Outcome Measures

Name	Time	Method
Adverse events related to the procedure of intra bone marrow islet infusion	up to 3 years

Secondary Outcome Measures

Name	Time	Method
Beta-cell function	up to 3 years	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

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milan, Italy