Bone Marrow Autotransplantation in Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821899
• Other study ID #: BMATxDM1
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: March 19, 2012
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: March 2012
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Spain	Enric Esmatjes	Barcelona
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration.		12 months	Yes
Secondary	Evaluate number of hypoglycemias 1,3,6, and 12 months after autologous bone marrow blood administration.		12 months	Yes
Secondary	Evaluate insulin dose 1,3,6, and 12 months after autologous bone marrow blood administration.		12 months	Yes
Secondary	Evaluate GADab titers and treatment tolerance 1,3,6, and 12 months after autologous bone marrow blood administration.		12 months	Yes