Bone Marrow vs Liver as Site for Islet Transplantation

Type 1 Diabetes Clinical Trial

— IsletBOM2  

Official title:

Bone Marrow vs Liver as Site for Islet Transplantation in Patients With Type 1 Diabetes: Pilot Study to Evaluate Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722682
• Other study ID #: IsletBOM2
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2012
• Est. completion date: December 2017

Study information

• Verified date: November 2020
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Biological:
• Human pancreatic islet transplantation

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Ospedale San Raffaele	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Maffi P, Nano R, Monti P, Melzi R, Sordi V, Mercalli A, Pellegrini S, Ponzoni M, Peccatori J, Messina C, Nocco A, Cardillo M, Scavini M, Magistretti P, Doglioni C, Ciceri F, Bloem SJ, Roep BO, Secchi A, Piemonti L. Islet Allotransplantation in the Bone Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin secretion under stimulation	basal and -10 to 120 min time course of glucose, C-pep levels and insulin derived from the mixed meal tolerance test	month 12 post-Tx
Secondary	Incidence and severity of Adverse Events (AE) and Serious Adverse Events (SAE)		throughout the study up to 1 year after first transplant
Secondary	Insulin requirement	Change in average daily insulin requirements	month 1, 3, 6, 9, 12 post- transplant
Secondary	Islet function	change in HbA1c, Transplant Estimated Function (TEF) and fasting C-peptide levels	month 1, 3, 6, 9, 12 post-Tx

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