UCMSCs Combined With Standard Therapy for the Treatment of Newly Diagnosed Type 1 Diabetes

NCT06407297 | Recruiting

• 1 other identifier: CZYZ-T1DM-2023-IIT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to investigate the safety and tolerability of intravenous infusion of allogeneic umbilical cord mesenchymal stem cells in pediatric patients diagnosed with newly onset type 1 diabetes

Conditions

Newly Diagnosed Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Safety assessment

  Changes in safety parameters of patients during the study period since baseline. Measured through the registration of adverse events and other safety parameters.

  Throughout the study until Week 52

• Efficacy Assessment

  Delta-change of C-peptide Area Under the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at Week 52 following UCMSCs/Placebo infusion when compared to test performed before start of treatment.

  Week 52

Secondary Outcomes (2)

• Efficacy Assessment: HbA1c

  Week 52

• Efficacy Assessment: Dose of exogenous insulin

  Week 52

Study Arms (2)

Experimental

EXPERIMENTAL

Drug: UCMSCs

Placebo Comparator

PLACEBO COMPARATOR

Drug: Placebo

Interventions

UCMSCs DRUG

Peripheral intravenous infusion of umbilical cord mesenchymal stem cells

Experimental

Placebo DRUG

Peripheral intravenous infusion of Placebo

Placebo Comparator

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Meets the diagnostic criteria for diabetes according to the World Health Organization (WHO) guidelines from 1999.
• Presence of at least one pancreatic autoantibody, or idiopathic type 1 diabetes mellitus (T1DM) with negative autoantibody testing.
• Ages 8 to 18 years, regardless of gender.
• Newly diagnosed T1DM within the past 6 months.
• Fasting C-peptide ≥0.1 nmol/L and postprandial 2-hour C-peptide \>0.2 nmol/L.
• Voluntary acceptance of stem cell transplantation therapy by the individual, their family members, or legal guardians, and signing of an informed consent form.

You may not qualify if:

• Diabetic ketoacidosis is not under control.
• Severe allergic constitution.
• BMI \<14 or \>35.
• History of other autoimmune diseases, hematologic disorders.
• HIV positive, carrier of viral hepatitis, active phase of viral hepatitis, or other uncontrolled infectious diseases.
• History of acute pancreatitis, pulmonary embolism, or other thrombotic diseases, as well as severe diseases of the heart, liver, kidneys, respiratory system, nervous system, etc.
• Suffering from gestational diabetes, monogenic diabetes, diabetes caused by pancreatic injury, or other secondary diabetes (such as Cushing's syndrome, thyroid dysfunction, or acromegaly-induced diabetes);
• Pregnancy or planning pregnancy within 3 months before or after treatment, as well as breastfeeding women.
• Mental illness, alcohol or drug abuse, inability to comply with treatment.
• Known or suspected tumors.
• According to the investigator's judgment, there are other clinical conditions that may endanger the safety of the subjects.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Study Officials

• Hao Yin

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Yin

CONTACT

13901677738; yinhaoshanghai@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 9, 2024
• Study Start: May 23, 2024
• Primary Completion: September 30, 2025
• Study Completion: May 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-05

Locations

CN (1)