Bone Marrow as an Alternative Site for Islet Transplantation

March 4, 2015 updated by: Piemonti Lorenzo, Ospedale San Raffaele

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intra BM islet infusion
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
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beta-cell function
Time Frame: 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
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Raffaele

Collaborators

European Union

Investigators

  • Principal Investigator: Lorenzo Piemonti, MD, Fondazione Centro San Raffaele del Monte Tabor
  • Study Director: Paola Maffi, MD, Fondazione Centro San Raffaele del Monte Tabor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

April 28, 2011

First Posted (Estimate)

May 2, 2011

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMT1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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