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Completed

NCT Number: NCT00821899

Bone Marrow Autotransplantation in Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Enric Esmatjes, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

administration of autologous bone marrow blood

Biological

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

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2009
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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