Bone Marrow Autotransplantation in Type 1 Diabetes

March 19, 2012 updated by: Enric Esmatjes, Hospital Clinic of Barcelona

Regeneration of Insulin Production in Patients With Type 1 Diabetes by Autologous Bone Marrow Blood Infusion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic
      • Barcelona, Spain, 08036
        • Enric Esmatjes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Esmatjes Enric, MD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMATxDM1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes Mellitus

Clinical Trials on administration of autologous bone marrow blood

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe