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| Name | Class |
|---|---|
| European Union | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra bone marrow islet infusion | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events related to the procedure of intra bone marrow islet infusion | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Piemonti, MD | Fondazione Centro San Raffaele del Monte Tabor | Principal Investigator |
| Paola Maffi, MD | Fondazione Centro San Raffaele del Monte Tabor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19773545 | Background | 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. | |
| 20719074 | Background |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
| 23733196 | Result | 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. |
| 30130323 | Derived | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |