Trial record 8 of 32 for:
Islets of Langerhans Transplantation | Open Studies
Bone Marrow vs Liver as Site for Islet Transplantation (IsletBOM 2)
This study is currently recruiting participants.
Verified November 2012 by Ospedale San Raffaele
Sponsor:
Ospedale San Raffaele
Collaborator:
Ministry of Health, Italy
Information provided by (Responsible Party):
Piemonti Lorenzo, Ospedale San Raffaele
ClinicalTrials.gov Identifier:
NCT01722682
First received: October 31, 2012
Last updated: November 5, 2012
Last verified: November 2012
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Purpose
The goal of this study is to evaluate safety and efficacy of bone marrow (BM) as site for pancreatic islet transplantationin humans. Our hypothesis is that BM represents a better site than liver (currently the location of choice for this procedure) thanks to its potential capacity to favor islet engraftment. To address our hypothesis we propose herein a randomized phase II trial to compare BM and liver as sites for islet transplantation in T1D patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes |
Biological: Human pancreatic islet transplantation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bone Marrow vs Liver as Site for Islet Transplantation in Patients With Type 1 Diabetes: Pilot Study to Evaluate Efficacy |
Resource links provided by NLM:
Further study details as provided by Ospedale San Raffaele:
Primary Outcome Measures:
- Insulin secretion under stimulation [ Time Frame: month 12 post-Tx ] [ Designated as safety issue: No ]basal and -10 to 120 min time course of glucose, C-pep levels and insulin derived from the mixed meal tolerance test
Secondary Outcome Measures:
- Incidence and severity of Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: throughout the study up to 1 year after first transplant ] [ Designated as safety issue: Yes ]
- Insulin requirement [ Time Frame: month 1, 3, 6, 9, 12 post- transplant ] [ Designated as safety issue: No ]Change in average daily insulin requirements
- Islet function [ Time Frame: month 1, 3, 6, 9, 12 post-Tx ] [ Designated as safety issue: No ]change in HbA1c, Transplant Estimated Function (TEF) and fasting C-peptide levels
| Estimated Enrollment: | 12 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A: intraportal islet infusion
Patients will received islet into the liver through the portal venous circulation (standard procedure)
|
Biological: Human pancreatic islet transplantation |
|
Experimental: B: intra BM islet infusion
Patients will received an intra BM islet infusion at the level of the iliac crest. The direct intra BM administration will be performed following the same procedures that our institution utilizes for administration of cord-blood cells in patients with acute leukemia (Lancet Oncol. 2008;9:831). The procedure is easy and reproducible: a standard needle for BM aspiration is inserted in the iliac crest and cells are gently infused.
|
Biological: Human pancreatic islet transplantation |
Detailed Description:
The study is a phase II, single center, open label, pilot study. We will recruit 12 patients with T1D to be randomly (1:1) assigned to receive islet either into the liver through the portal venous circulation (standard procedure; arm A, n=6) or directly into the BM at the level of the iliac crest (arm B, n=6). Patients will be selected from those eligible for islet Tx based on local practice and guidelines.
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
Exclusion Criteria:
- presence of hematologic disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01722682
Contacts
| Contact: Lorenzo Piemonti, MD | +390226432706 | piemonti.lorenzo@hsr.it |
| Contact: Paola Maffi, MD | +390226432575 | maffi.paola@hsr.it |
Locations
| Italy | |
| Ospedale San Raffaele | Recruiting |
| Milan, Italy, 20132 | |
| Contact: Paola Maffi, MD +390226432575 paola.maffi@hsr.it | |
| Contact: Lorenzo Piemonti, MD +390226432643 lorenzo.piemonti@hsr.it | |
| Sub-Investigator: Paola Maffi, MD | |
Sponsors and Collaborators
Ospedale San Raffaele
Ministry of Health, Italy
Investigators
| Principal Investigator: | Lorenzo Piemonti, MD | Ospedale San Raffaele |
More Information
Additional Information:
No publications provided
| Responsible Party: | Piemonti Lorenzo, Head of Beta Cell Biology Unit, CO-Director Human Islet Transplantation Program (ITP), Ospedale San Raffaele |
| ClinicalTrials.gov Identifier: | NCT01722682 History of Changes |
| Other Study ID Numbers: | IsletBOM 2 |
| Study First Received: | October 31, 2012 |
| Last Updated: | November 5, 2012 |
| Health Authority: | Italy: Centro Nazionale Trapianti (CNT) |
Keywords provided by Ospedale San Raffaele:
|
Diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013