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Trial record 1 of 1 for:    NCT00989547
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Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00989547
Recruitment Status : Unknown
Verified July 2013 by Technische Universität München.
Recruitment status was:  Active, not recruiting
First Posted : October 5, 2009
Last Update Posted : July 23, 2013
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:

Type 1 diabetes (T1D) is still associated with tremendous morbidity and premature mortality.

Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. Unfortunately, there is presently no permanent cure for diabetes. Whole pancreas or islet cell transplantation is available only to a very limited number of patients and necessitates potential lifelong immunosuppressive therapy. Autologous stem cell transplants have been used successfully for ALL (acute lymphoblastic leukemia), AML (acute myeloblastic leukemia) and for the treatment of a variety of cancers including breast cancer and neuroblastomas, and more recently for the treatment of autoimmune disorders such as multiple sclerosis (MS), lupus-like disease, and rheumatic disorders. Recently it was shown that bone marrow-derived stems cells transplanted into diabetic mice led to reduced hyperglycemia within 7 days after transplantation and was sustained until they were sacrificed at 35 days post-transplantation. The investigators' goal is to transfuse autologous umbilical cord blood into 23 children (Germany 10 and 20 Controls) with T1D in an attempt to regenerate pancreatic islet insulin producing beta cells and improve blood glucose control. As secondary goals, the investigators aim to track the migration of transfused cord blood stem and study the potential changes in metabolism/immune function leading to islet regeneration.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Children Other: Umbilical Cord Blood VITA 34 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transfusion of Autologous Umbilical Cord Blood to Reverse Hyperglycemia in Children With Type 1 Diabetes - A Pilot Study.
Study Start Date : September 2008
Estimated Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: A Other: Umbilical Cord Blood VITA 34
Intervention type: Autologous Umbilical Cord Blood Transfusion

No Intervention: B

Primary Outcome Measures :
  1. insulin production
    change in median area under the curve (AUC) for C-peptide (measure of insulin production) from baseline to 2 years during a 2h Mixed Meal Tolerance Test was used as the primary outcome measure and was reported in ng/mL/120 minutes.

Secondary Outcome Measures :
  1. Insulin Dose, Autoantibody levels, T-cell functional response assays, Cytokine levels
    Insulin Dose, Autoantibody levels, T-cell functional response assays, Cytokine levels

Other Outcome Measures:
  1. glycated hemoglobin (HbA1c)

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Must have a diagnosis of T1D and have stored umbilical cord blood (10 patients sought) at the cord bank Vita 34.
  • TID diagnosis will be defined as having a clear history of polydipsia, polyphagia, polyuria, and weight loss consistent with a clinical diagnosis, diagnosis will mot be based solely upon the presence of autoantibodies.
  • Cord blood meets all selection and testing criteria (see below).
  • Normal screening values for CBC, Renal function and electrolytes (BMP).
  • Willing to comply with intensive diabetes management
  • Not younger than 1 year of age

Exclusion Criteria:

  • Have complicating medical issues that would interfere with blood drawing or monitoring.
  • Require chronic use of steroids or other immunosuppressive agents for other conditions.
  • Cord Blood with viability < 50%.
  • Positive infectious disease markers from mothers blood or cord at time of collection (See below for details).
  • Any evidence of illness on planned infusion date (i.e. fever >38.5 C, vomiting, diarrhea, wheezing, or crackles).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00989547

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Forschergruppe Diabetes der Technischen Universität
München, Bavaria, Germany, 80804
Sponsors and Collaborators
Technische Universität München
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Responsible Party: Technische Universität München Identifier: NCT00989547    
Other Study ID Numbers: 593
First Posted: October 5, 2009    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases