Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00989547
First received: October 2, 2009
Last updated: July 22, 2013
Last verified: July 2013

October 2, 2009
July 22, 2013
September 2008
September 2014   (final data collection date for primary outcome measure)
insulin production [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00989547 on ClinicalTrials.gov Archive Site
Insulin Dose, Autoantibody levels, T-cell functional response assays, Cytokine levels [ Designated as safety issue: No ]
Insulin Dose, Autoantibody levels, T-cell functional response assays, Cytokine levels
Not Provided
glycated hemoglobin (HbA1c) [ Designated as safety issue: No ]
Not Provided
 
Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)
Transfusion of Autologous Umbilical Cord Blood to Reverse Hyperglycemia in Children With Type 1 Diabetes - A Pilot Study.

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 1 Diabetes
  • Children
Other: Umbilical Cord Blood VITA 34
Intervention type: Autologous Umbilical Cord Blood Transfusion
  • Active Comparator: A
    Intervention: Other: Umbilical Cord Blood VITA 34
  • No Intervention: B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
Not Provided
September 2014   (final data collection date for primary outcome measure)

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).
Both
1 Year and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00989547
593
Yes
Technische Universität München
Technische Universität München
Not Provided
Not Provided
Technische Universität München
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP