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
  Purpose

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 Intervention Phase
Type 1 Diabetes
Children
Other: Umbilical Cord Blood VITA 34
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • glycated hemoglobin (HbA1c) [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: September 2008
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Other: Umbilical Cord Blood VITA 34
Intervention type: Autologous Umbilical Cord Blood Transfusion
No Intervention: B

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989547

Locations
Germany
Forschergruppe Diabetes der Technischen Universität
München, Bavaria, Germany, 80804
Sponsors and Collaborators
Technische Universität München
  More Information

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT00989547     History of Changes
Other Study ID Numbers: 593
Study First Received: October 2, 2009
Last Updated: July 22, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014