Bone Marrow Autotransplantation in Type 1 Diabetes
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00821899 |
Recruitment Status :
Completed
First Posted : January 14, 2009
Last Update Posted : March 20, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes Mellitus | Biological: administration of autologous bone marrow blood | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Regeneration of Insulin Production in Patients With Type 1 Diabetes by Autologous Bone Marrow Blood Infusion |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2010 |

- Biological: administration of autologous bone marrow blood
administration of autologous bone marrow blood through magna pancreatic artery after femoral catheterization once during 12-month study period
- Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration. [ Time Frame: 12 months ]
- Evaluate number of hypoglycemias 1,3,6, and 12 months after autologous bone marrow blood administration. [ Time Frame: 12 months ]
- Evaluate insulin dose 1,3,6, and 12 months after autologous bone marrow blood administration. [ Time Frame: 12 months ]
- Evaluate GADab titers and treatment tolerance 1,3,6, and 12 months after autologous bone marrow blood administration. [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- diabetes type 1 patients
- 18 to 50 years of age
- more than 5 years of evolution of the disease
- brittle diabetes (HbA1c > 8.5 % with intensified treatment or severe hypoglycemia episodes
Exclusion Criteria:
- history of cancer
- hematologic alterations
- infectious disease positivity (HIV, HCV etc.)
- diabetic nephropathy
- cardiac failure
- liver disease
- autoimmune systemic disease
- allergy to iodine contrast or anesthesia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821899
Spain | |
Enric Esmatjes | |
Barcelona, Spain, 08036 | |
Hospital Clinic | |
Barcelona, Spain, 08036 |
Principal Investigator: | Esmatjes Enric, MD | Hospital Clinic of Barcelona |
Responsible Party: | Enric Esmatjes, MD, Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT00821899 |
Other Study ID Numbers: |
BMATxDM1 |
First Posted: | January 14, 2009 Key Record Dates |
Last Update Posted: | March 20, 2012 |
Last Verified: | March 2012 |
diabetes type 1 bone marrow transplantation |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |