Bone Marrow Autotransplantation in Type 1 Diabetes

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00821899

Enrollment

Registered

2009-01-14

Start date

2009-01-31

Completion date

2010-05-31

Last updated

2012-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetes type 1, bone marrow transplantation

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.

Interventions

BIOLOGICALadministration of autologous bone marrow blood

administration of autologous bone marrow blood through magna pancreatic artery after femoral catheterization once during 12-month study period

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026