Type 1 DiabetesNCT01345227
Bone Marrow as an Alternative Site for Islet Transplantation
A study testing Intra bone marrow islet infusion in people with Type 1 Diabetes and Postpancreatectomy Hyperglycemia, run by Ospedale San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Postpancreatectomy Hyperglycemia
- What is being tested?
- Intra bone marrow islet infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2009to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- presence of hematologic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Assess Feasibility and Safety of Bone Marrow as Alternative Site in Islet Transplant Patients
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.
Read the 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).
- Conditions
- Type 1 Diabetes, Postpancreatectomy Hyperglycemia
- Being tested
- Intra bone marrow islet infusion
- Keywords
- Type 1 diabetes, islet transplantation, autotransplantation
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra bone marrow islet infusionProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Intra BM islet infusion | Experimental | single intra BM islet infusion at the level of the iliac crest will be performed in patients having contraindications for intraportal infusion Receives: Procedure: Intra bone marrow islet infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events related to the procedure of intra bone marrow islet infusion
Measured: up to 3 years
Secondary outcomes (1)
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
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startAug 2009
- Primary completionApr 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, Piemonti Lorenzo, Ospedale San Raffaele
- Investigators
- Lorenzo Piemonti, MD, Principal investigator, Fondazione Centro San Raffaele del Monte TaborPaola Maffi, MD, Study director, Fondazione Centro San Raffaele del Monte Tabor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345227
- Sponsor's protocol ID
- BMT1
- Status last verified
- Oct 2012
- First submitted
- 28 Apr 2011
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19773545Ciceri 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.
PubMed 20719074Maffi 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.
PubMed 23733196Maffi 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.
PubMed 30130323
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Feasibility and Safety of Bone Marrow as Alternative Site in Islet Transplant Patients
- ClinicalTrials.gov ID
- NCT01345227
- Acronym / sponsor ID
- BMT1
- Conditions
- Type 1 Diabetes, Postpancreatectomy Hyperglycemia
- Keywords
- Type 1 diabetes, islet transplantation, autotransplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Aug 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra BM islet infusion | Experimental | Procedure: Intra bone marrow islet infusionsingle intra BM islet infusion at the level of the iliac crest will be performed in patients having contraindications for intraportal infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- presence of hematologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra bone marrow islet infusionA 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). | Procedure or surgery | Intra BM islet infusion |
Primary outcome
Adverse events related to the procedure of intra bone marrow islet infusion
Time frame: up to 3 years
1 secondary outcome
Beta-cell function
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Background: PubMed 19773545Cantarelli 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.
- Background: PubMed 20719074Ciceri 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 publication: PubMed 23733196Maffi 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.
- Derived from this study: PubMed 30130323Maffi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Piemonti, MD principal investigator
Fondazione Centro San Raffaele del Monte Tabor
Paola Maffi, MD study director
Fondazione Centro San Raffaele del Monte Tabor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra bone marrow islet infusion in people with Type 1 Diabetes and Postpancreatectomy Hyperglycemia, run by Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events related to the procedure of intra bone marrow islet infusion (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01345227, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.