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Bone Marrow as an Alternative Site for Islet Transplantation

NCT01345227 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2015-03-06

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Intra bone marrow islet infusion

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).

Sponsors & Collaborators

Principal Investigators

  • Lorenzo Piemonti, MD · Fondazione Centro San Raffaele del Monte Tabor

  • Paola Maffi, MD · Fondazione Centro San Raffaele del Monte Tabor

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-04-30
Completion
2011-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01345227 on ClinicalTrials.gov