None listed
Conditions
Brief summary
The CORD study is a pilot study aiming to determine the feasibility of reinfusing cord blood in children who are at risk of developing type 1 diabetes. The hypothesis is that autologous cord blood, when reinfused into children at high risk of developing type 1 diabetes, will resotre immune tolerance and prevent or mitigate the development of type 1 diabetes. Participants aged 1-12 years with a relative with type 1 diabetes will be tested every 12 months for the development of islet antigens. Following screening, a target treatment group of 20 with two or more autoantibodies, will receive an infusion of their autologous cord blood. Participants will be followed for 5 years or until they develop diabetes.
Interventions
The trial involves two stages. The first stage is to screen, with a blood test, those with a first or second degree relative with type 1 diabetes, for diabetes autoantibodies. The purpose of screening is to determine their risk of developing type 1 diabetes. The screening blood tests can be conducted every 12months for the duration of the study to monitor the development of said autoantibodies. Rescreening will be offerred to all participants during the 5 years study duration and will be conduct
The trial involves two stages. The first stage is to screen, with a blood test, those with a first or second degree relative with type 1 diabetes, for diabetes autoantibodies. The purpose of screening is to determine their risk of developing type 1 diabetes. The screening blood tests can be conducted every 12months for the duration of the study to monitor the development of said autoantibodies. Rescreening will be offerred to all participants during the 5 years study duration and will be conducted with the consent of the participant. Those at high risk (positive for two or more autoantibodies) will be invited to participate in stage 2 where they will be given a reinfusion of their autologous cord blood via intravenous infusion. This will be a one off treatment that will take approximately five hours with the reinfusion taking 1 hour followed by a 4 hour observation period. Post reinfusion all participants will enter follow-up with visits and blood tests every 3 months for the first year and every 6 months the following two years after treatment to monitor effect.
Sponsors
Sydney Children's Hospitals Network (Westmead)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
The key inclusion criteria for the study requires that potential participants must be aged 1-12 years old, have cord blood collected and stored from birth, and not have diabetes.
Exclusion criteria
Participants who have diabetes, do not have adequate quality and quantity of cord blood stored and impaired renal, liver or immunological function will be excluded.
Outcome results
None listed