Bone Marrow as an Alternative Site for Islet Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Piemonti Lorenzo, Scientific Institute San Raffaele
ClinicalTrials.gov Identifier:
NCT01345227
First received: April 28, 2011
Last updated: October 3, 2012
Last verified: October 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 Ospedale San Raffaele:

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

Secondary Outcome Measures:
  • Beta-cell function [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    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
Estimated Study Completion Date: July 2013
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Scientific Institute San Raffaele
ClinicalTrials.gov Identifier: NCT01345227     History of Changes
Other Study ID Numbers: BMT1
Study First Received: April 28, 2011
Last Updated: October 3, 2012
Health Authority: Italy: National Institute of Health

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

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

ClinicalTrials.gov processed this record on August 28, 2014