Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
NCT03835312

Sequential Transplantation of UCBSCs and Islet Cells in Children and Adolescents With Monogenic Immunodeficiency T1DM

Led by Children's Hospital of Fudan University · Updated on 2026-03-17

50

Participants Needed

1

Research Sites

618 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study evaluates the efficacy of sequential transplantation of umbilical cord blood stem cells and islet cells in children with monogenic immunodeficiency type 1 diabetes mellitus. Umbilical cord blood stem cell transplantation will be performed first. Children with stable immune reconstruction will than receive islet cell transplantation.

CONDITIONS

Official Title

Sequential Transplantation of UCBSCs and Islet Cells in Children and Adolescents With Monogenic Immunodeficiency T1DM

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children diagnosed with type 1 diabetes mellitus and genetic immunodeficiency
  • Clinical signs of diabetes including increased hunger, thirst, weight loss, or diabetic ketoacidosis confirmed by blood sugar, islet function, and autoimmune antibody tests
  • Presence of one or more extrapancreatic organ damages such as inflammatory bowel disease, kidney impairment, repeated infections (mouth, skin, anus, or body), immune hepatitis, chronic immune iridocyclitis, immune adrenalitis, pituitary inflammation, rheumatoid disease, immune vasculitis, systemic lupus erythematosus, or other organ damage besides thyroid
  • Recurrence of the above conditions despite regular clinical and symptomatic treatments
  • Genetic mutation confirmed by gene sequencing linked to autoimmune or immune dysfunction causing multiple organ problems
Not Eligible

You will not qualify if you...

  • Availability of mature and effective treatment methods
  • Positive for HIV, hepatitis B (HBV), or hepatitis C (HCV) infections
  • Currently in an active infection period
  • Active stage of malignant tumors
  • Presence of other fatal diseases
  • Existence of mental or psychological disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Actively Recruiting

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Research Team

L

Luo Feihong

CONTACT

X

Xu Zhenran

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Sequential Transplantation of UCBSCs and Islet Cells in Children and Adolescents With Monogenic Immunodeficiency T1DM | DecenTrialz