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Bone Marrow vs Liver as Site for Islet Transplantation

NCT ID: NCT01722682

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A: intraportal islet infusion

Patients will received islet into the liver through the portal venous circulation (standard procedure)

Group Type ACTIVE_COMPARATOR

Human pancreatic islet transplantation

Intervention Type BIOLOGICAL

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.

Group Type EXPERIMENTAL

Human pancreatic islet transplantation

Intervention Type BIOLOGICAL

Interventions

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Human pancreatic islet transplantation

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Italy

OTHER_GOV

Sponsor Role collaborator

Ospedale San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Piemonti Lorenzo

Head of Beta Cell Biology Unit, CO-Director Human Islet Transplantation Program (ITP)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lorenzo Piemonti, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Raffaele

Locations

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Ospedale San Raffaele

Milan, , Italy

Site Status

Countries

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Italy

References

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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 Marrow of Patients With Type 1 Diabetes: A Pilot Randomized Trial. Transplantation. 2019 Apr;103(4):839-851. doi: 10.1097/TP.0000000000002416.

Reference Type RESULT
PMID: 30130323 (View on PubMed)

Related Links

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http://www.hsr.it/ricerca/divisioni-centri-istituti-e-programmi-di-ricerca/islet-trasplantation-program-itp/

Related Info

Other Identifiers

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IsletBOM2

Identifier Type: -

Identifier Source: org_study_id