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Bone Marrow Autotransplantation in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT00821899
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : March 20, 2012
Sponsor:
Information provided by (Responsible Party):
Enric Esmatjes, Hospital Clinic of Barcelona

Study Description
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Brief Summary:
This project evaluates the effectiveness of the administration of autologous bone marrow blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. After mobilization of hematopoietic progenitors (G-CSF) during 3 days, 50 to 90 mL of bone marrow blood will be obtained by multifunction in the posterior iliac crest. The material obtained will be implanted into the pancreas through the magna pancreatic artery after femoral catheterization.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Biological: administration of autologous bone marrow blood Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Evaluate number of hypoglycemias 1,3,6, and 12 months after autologous bone marrow blood administration. [ Time Frame: 12 months ]
  2. Evaluate insulin dose 1,3,6, and 12 months after autologous bone marrow blood administration. [ Time Frame: 12 months ]
  3. Evaluate GADab titers and treatment tolerance 1,3,6, and 12 months after autologous bone marrow blood administration. [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Spain
Enric Esmatjes
Barcelona, Spain, 08036
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Esmatjes Enric, MD Hospital Clinic of Barcelona
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Enric Esmatjes, Hospital Clinic of Barcelona:
diabetes type 1
bone marrow transplantation
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases