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Bone Marrow as an Alternative Site for Islet Transplantation

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ClinicalTrials.gov Identifier: NCT01345227
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : March 6, 2015
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Piemonti Lorenzo, 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.

Condition or disease Intervention/treatment
Type 1 Diabetes Postpancreatectomy Hyperglycemia Procedure: Intra bone marrow islet infusion

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  (Clinical Trial)
Actual Enrollment : 8 participants
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
Study Start Date : August 2009
Primary Completion Date : April 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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).



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

Secondary Outcome Measures :
  1. 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



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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

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

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 Posted: May 2, 2011    Key Record Dates
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