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Bone Marrow as an Alternative Site for Islet Transplantation

Primary Purpose

Type 1 Diabetes, Postpancreatectomy Hyperglycemia

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Intra bone marrow islet infusion

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, islet transplantation, autotransplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

IRCCS San Raffaele

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intra BM islet infusion

Arm Description

single intra BM islet infusion at the level of the iliac crest will be performed in patients having contraindications for intraportal infusion

Outcomes

Primary Outcome Measures

Adverse events related to the procedure of intra bone marrow islet infusion

Secondary Outcome Measures

Beta-cell function

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

Full Information

NCT ID

NCT01345227

First Posted

April 28, 2011

Last Updated

March 4, 2015

Sponsor

Ospedale San Raffaele

Collaborators

European Union

1. Study Identification

Unique Protocol Identification Number

NCT01345227

Brief Title

Bone Marrow as an Alternative Site for Islet Transplantation

Official Title

Pilot Study to Assess Feasibility and Safety of Bone Marrow as Alternative Site in Islet Transplant Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ospedale San Raffaele

Collaborators

European Union

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes, Postpancreatectomy Hyperglycemia

Keywords

Type 1 diabetes, islet transplantation, autotransplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intra BM islet infusion

Arm Type

Experimental

Arm Description

single intra BM islet infusion at the level of the iliac crest will be performed in patients having contraindications for intraportal infusion

Intervention Type

Procedure

Intervention Name(s)

Intra bone marrow islet infusion

Intervention Description

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 Measure Information:

Title

Adverse events related to the procedure of intra bone marrow islet infusion

Time Frame

up to 3 years

Secondary Outcome Measure Information:

Title

Beta-cell function

Description

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lorenzo Piemonti, MD

Organizational Affiliation

Fondazione Centro San Raffaele del Monte Tabor

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paola Maffi, MD

Organizational Affiliation

Fondazione Centro San Raffaele del Monte Tabor

Official's Role

Study Director

Facility Information:

Facility Name

IRCCS San Raffaele

City

Milan

ZIP/Postal Code

20132

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

19773545

Citation

Cantarelli E, Melzi R, Mercalli A, Sordi V, Ferrari G, Lederer CW, Mrak E, Rubinacci A, Ponzoni M, Sitia G, Guidotti LG, Bonifacio E, Piemonti L. Bone marrow as an alternative site for islet transplantation. Blood. 2009 Nov 12;114(20):4566-74. doi: 10.1182/blood-2009-03-209973. Epub 2009 Sep 22.

Results Reference

background

PubMed Identifier

20719074

Citation

Ciceri F, Piemonti L. Bone marrow and pancreatic islets: an old story with new perspectives. Cell Transplant. 2010;19(12):1511-22. doi: 10.3727/096368910X514279. Epub 2010 Aug 17.

Results Reference

background

PubMed Identifier

23733196

Citation

Maffi P, Balzano G, Ponzoni M, Nano R, Sordi V, Melzi R, Mercalli A, Scavini M, Esposito A, Peccatori J, Cantarelli E, Messina C, Bernardi M, Del Maschio A, Staudacher C, Doglioni C, Ciceri F, Secchi A, Piemonti L. Autologous pancreatic islet transplantation in human bone marrow. Diabetes. 2013 Oct;62(10):3523-31. doi: 10.2337/db13-0465. Epub 2013 Jun 3. Erratum In: Diabetes. 2014 Jan;63(1):377.

Results Reference

result

PubMed Identifier

30130323

Citation

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.

Results Reference

derived

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Bone Marrow as an Alternative Site for Islet Transplantation

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