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Bone Marrow Autotransplantation in Type 1 Diabetes

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
administration of autologous bone marrow blood
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring diabetes type 1, bone marrow transplantation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Enric Esmatjes
  • Hospital Clinic

Outcomes

Primary Outcome Measures

Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration.

Secondary Outcome Measures

Evaluate number of hypoglycemias 1,3,6, and 12 months after autologous bone marrow blood administration.
Evaluate insulin dose 1,3,6, and 12 months after autologous bone marrow blood administration.
Evaluate GADab titers and treatment tolerance 1,3,6, and 12 months after autologous bone marrow blood administration.

Full Information

First Posted
January 13, 2009
Last Updated
March 19, 2012
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT00821899
Brief Title
Bone Marrow Autotransplantation in Type 1 Diabetes
Official Title
Regeneration of Insulin Production in Patients With Type 1 Diabetes by Autologous Bone Marrow Blood Infusion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
diabetes type 1, bone marrow transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
administration of autologous bone marrow blood
Intervention Description
administration of autologous bone marrow blood through magna pancreatic artery after femoral catheterization once during 12-month study period
Primary Outcome Measure Information:
Title
Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluate number of hypoglycemias 1,3,6, and 12 months after autologous bone marrow blood administration.
Time Frame
12 months
Title
Evaluate insulin dose 1,3,6, and 12 months after autologous bone marrow blood administration.
Time Frame
12 months
Title
Evaluate GADab titers and treatment tolerance 1,3,6, and 12 months after autologous bone marrow blood administration.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esmatjes Enric, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Enric Esmatjes
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20101385
Citation
Esmatjes E, Montana X, Real MI, Blanco J, Conget I, Casamitjana R, Rovira M, Gomis R, Marin P. Regeneration of insulin production by autologous bone marrow blood autotransplantation in patients with type 1 diabetes. Diabetologia. 2010 Apr;53(4):786-9. doi: 10.1007/s00125-010-1660-9. Epub 2010 Jan 26. No abstract available.
Results Reference
derived

Learn more about this trial

Bone Marrow Autotransplantation in Type 1 Diabetes

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