Transfusion of Autologous Umbilical Cord Blood to Reverse Hyperglycemia in Children with Type 1 Diabetes - A Pilot Study
- Conditions
- Type 1 Diabetes
- Registration Number
- EUCTR2007-007694-23-DE
- Lead Sponsor
- Forschergruppe Diabetes e. V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 23
1. Must have a diagnosis of type 1 diabetes.
2. Have stored umbilical cord blood in an accredited cord bank.
3. Willing to comply with intensive diabetes management.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Have complicating medical issues that would interfere with blood drawing or monitoring.
2. Require chronic use of steroids or other immunosuppressive agents for other conditions.
3. Cord blood viability <50%.
4. Participation in another immune intervention study.
5. Positive infectious disease markers from mothers blood or cord at time of collection.
6. An evidence of illness on planned infusion date (i.e. fever >38.5 C, vomiting, diarrhea, wheezing, or crackles
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Transfuse autologius umbilical cord blood into children with type 1 diabetes in an attempt to regenerate pancreatic islet insulin producing beta cells and improve blood glucose control.;Secondary Objective: Track the survival of transfused cord blood stem cells and study the potential changes in metabolism / immune function leading to islet regeneration;Primary end point(s): Changes in HbA1c levels, ICA- GAD- and IA2-antibody production, T-cell production, residual beta cell function (C-Peptid-levels) and blood glucose leves over time.
- Secondary Outcome Measures
Name Time Method