Transfusion of Autologous Umbilical Cord Blood to Reverse Hyperglycemia in Children with Type 1 Diabetes - A Pilot Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007694-23-DE

Enrollment

Registered

2008-03-03

Start date

2008-07-28

Completion date

Unknown

Last updated

2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Interventions

Trade Name: Nabelschnurblut Vita 34 Product Name: Nabelschnurblut Vita 34® Pharmaceutical Form: Suspension for injection INN or Proposed INN: Nabelschnurblut Vita 34 Concentration unit: U unit(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 38.5 C, vomiting, diarrhea, wheezing, or crackles

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026