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Bone Marrow as an Alternative Site for Islet Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01345227
First Posted: May 2, 2011
Last Update Posted: March 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
European Union
Information provided by (Responsible Party):
Piemonti Lorenzo, Ospedale San Raffaele
  Purpose
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.

Condition Intervention
Type 1 Diabetes Postpancreatectomy Hyperglycemia Procedure: Intra bone marrow islet infusion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Assess Feasibility and Safety of Bone Marrow as Alternative Site in Islet Transplant Patients

Resource links provided by NLM:


Further study details as provided by Piemonti Lorenzo, Ospedale San Raffaele:

Primary Outcome Measures:
  • Adverse events related to the procedure of intra bone marrow islet infusion [ Time Frame: up to 3 years ]

Secondary Outcome Measures:
  • 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


Enrollment: 8
Study Start Date: August 2009
Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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).
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345227


Locations
Italy
IRCCS San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
Ospedale San Raffaele
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
  More Information

Publications:
Responsible Party: Piemonti Lorenzo, Director Islet Transplantation Program, Ospedale San Raffaele
ClinicalTrials.gov Identifier: NCT01345227     History of Changes
Other Study ID Numbers: BMT1
First Submitted: April 28, 2011
First Posted: May 2, 2011
Last Update Posted: March 6, 2015
Last Verified: October 2012

Keywords provided by Piemonti Lorenzo, Ospedale San Raffaele:
Type 1 diabetes
islet transplantation
autotransplantation

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hyperglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases