Actively Recruiting
Study of Allogeneic Umbilical Cord Mesenchymal Stem Cells with Standard Therapy for Safety and Effects in Children with Newly Diagnosed Type 1 Diabetes
Led by Shanghai Changzheng Hospital · Updated on 2024-12-27
24
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of intravenous infusions of allogeneic umbilical cord mesenchymal stem cells (UCMSCs) in children and adolescents aged 8 to 18 years who have been newly diagnosed with type 1 diabetes. This study aims to preserve the body's own insulin production, assess metabolic control, treatment satisfaction, and immune response. The trial includes an initial open dose-escalation phase followed by a randomized, double-blind, placebo-controlled phase to compare UCMSC treatment with placebo in pediatric patients. The study involves two parts: the first includes 9 patients receiving escalating doses of UCMSCs, while the second part enrolls 24 patients randomized to receive either UCMSCs or placebo through peripheral intravenous infusion. All participants continue to receive standard therapy for their diabetes. The trial spans one year, with treatment administered within six months of diagnosis. Participants will be closely monitored throughout the 52-week study period for safety and effectiveness. Assessments include measuring insulin production through C-peptide levels, metabolic control, immunological profiles, and patient satisfaction with diabetes treatment. Researchers will conduct regular evaluations to track health status and any possible side effects, ensuring comprehensive safety follow-up during the full year of participation.
CONDITIONS
Official Title
UCMSCs Combined With Standard Therapy for the Treatment of Newly Diagnosed Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with diabetes according to WHO 1999 guidelines
- Presence of at least one pancreatic autoantibody or idiopathic type 1 diabetes with negative autoantibodies
- Aged 8 to 18 years, any gender
- Newly diagnosed with type 1 diabetes within the past 6 months
- Fasting C-peptide of at least 0.1 nmol/L and 2-hour postprandial C-peptide over 0.2 nmol/L
- Voluntary acceptance of stem cell treatment and signed informed consent by patient or guardians
You will not qualify if you...
- Uncontrolled diabetic ketoacidosis
- Severe allergic conditions
- Body mass index less than 14 or greater than 35
- History of other autoimmune diseases or blood disorders
- HIV positive, viral hepatitis carrier or active infection, or other uncontrolled infections
- History of acute pancreatitis, pulmonary embolism, thrombotic diseases, or severe illness affecting heart, liver, kidneys, lungs, or nervous system
- Gestational diabetes, monogenic diabetes, diabetes caused by pancreatic injury, or other secondary diabetes such as Cushing's syndrome, thyroid problems, or acromegaly-related diabetes
- Pregnancy, planning pregnancy within 3 months before or after treatment, or breastfeeding
- Mental illness, substance abuse, or inability to follow treatment
- Known or suspected tumors
- Other safety concerns as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
H
Hao Yin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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