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A prospective, open, self-controlled study on the effect and safety of autologous cord blood reinfusion on blood glucose control in type 1 diabetic children

A prospective, open, self-controlled study on the effect and safety of autologous cord blood reinfusion on blood glucose control in type 1 diabetic children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050309
Enrollment
Unknown
Registered
2021-08-26
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Type 1 diabetes

Interventions

Treatment group:Autologous umbilical cord blood transfusion

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Aged 1 to 18 years; 2.Meets the diagnostic criteria of T1DM according to the 2020 ADA guidelines, and stores autologous umbilical cord blood; 3.At least one of the following islet autoantibodies is positive: islet cell antibody, insulin autoantibody, tyrosine phospholipase antibody, glutamic acid decarboxylase antibody; 4.Autologous cord blood, and >=30ml; 5.The whole blood cell count, liver and kidney function and electrolyte are in the normal range; 6.Willing to obey the comprehensive management of diabetes.

Exclusion criteria

Exclusion criteria: 1.Any complex medical problems affecting umbilical cord blood transfusion and follow-up monitoring; 2.Long-term use of corticosteroids or other immunosuppressants to treat other diseases; 3.Suffer from a variety of chronic infectious or immunodeficiency diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, tuberculosis, etc.; 4.With any acute infectious disease, such as respiratory infection, intestinal infection, skin infection, etc., if you still want to participate in this study, you need to control the infection for at least a week.

Design outcomes

Primary

MeasureTime frame
Blood glucose control;Insulin dosage;Islet ß cell function index;

Secondary

MeasureTime frame
Immunological index;Diabetic complication;Anthropometric indicators;Security index;

Countries

China

Contacts

Public ContactLiang Liyang

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

liangliy@mail.sysu.edu.cn+86 13688891219

Outcome results

None listed

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