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Recruiting NCT06751199

UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes

No phase Interventional Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: human umbilical cord mesenchymal stem cells, allogeneic islet.
Who it may be relevant to
Registry conditions: Diabetes. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Investigation of Dose Escalation and Dose Expansion Study on the Safety and Efficacy of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes

Overview

The aim is to Investigate the safety and efficacy of Portal vein infusion Allogeneic Human umbilical cord mesenchymal stem cells combined with Allogeneic islet transplantation for the treatment of diabetes

Detailed description

This is an investigator-initiated trial (IIT). The first part is an open-label, dose-escalation study involving 9 patients between the ages of 18 and 70. The second part is a non-randomized, active comparator-controlled IIT with a parallel design, comparing allogeneic islet transplantation combined with human umbilical cord mesenchymal stem cells (hUCMSCs) to allogeneic islet transplantation alone in patients with diabetes.Besides safety, preservation of endogenous insulin production (measured as C-peptide concentrations) together with metabolic control, diabetes treatment satisfaction and immunological profile will be assessed.

Interventions

  • Drug human umbilical cord mesenchymal stem cells
    Portal vein infusion human umbilical cord mesenchymal stem cells
  • Drug allogeneic islet
    Portal vein infusion of allogeneic islet

Primary outcome measures

  • Safety assessment: Registration of adverse events [Time frame: Throughout the study until Week 52]
  • Efficacy Assessment: Evaluation of islet function [Time frame: Throughout the study until Week 52]
Secondary outcome measures (2)
  • Efficacy Assessment: HbA1c [Time frame: Week 52]
  • Dose of exogenous insulin [Time frame: Week 52]

Eligibility criteria

Inclusion criteria

  • Meets the 1999 World Health Organization diagnostic criteria for diabetes.
  • Aged 18-70, no gender restriction.
  • Islet function failure: fasting C-peptide < 0.1 nmol/L, 2-hour postprandial C-peptide < 0.2 nmol/L, and HbA1c ≥ 7%.
  • Meets the indications for islet transplantation alone:

i. Type 1 diabetes patients who experience unstable blood glucose despite strict insulin therapy, including frequent hypoglycemia or at least one severe hypoglycemic event in the past 12 months, or those with serious complications in other organs such as the kidneys; ii. Type 2 diabetes progressing to islet failure with poor blood glucose control as described above; iii. Patients with chronic pancreatitis or non-malignant pancreatic tumors who have undergone total or near-total pancreatectomy may receive autologous islet transplantation concurrently or allogeneic islet transplantation later.

  • The patient and their family or legal guardian voluntarily consent to stem cell transplantation therapy and sign the informed consent form.

Exclusion criteria

  • Diabetic ketoacidosis that is not yet controlled.
  • Severe allergic constitution, meaning prone to allergic reactions without a clear and identifiable cause.
  • BMI < 14 or > 35.
  • Severe anemia (hemoglobin < 8 g/dL in males, < 7 g/dL in females).
  • HIV-positive, carriers of viral hepatitis or in the active phase, or other uncontrolled infectious diseases.
  • History of acute pancreatitis, pulmonary embolism, or other thrombotic diseases, as well as severe heart, liver, kidney, respiratory, or neurological diseases.
  • Patients with gestational diabetes, monogenic diabetes, diabetes due to pancreatic damage, or other secondary diabetes (e.g., diabetes caused by Cushing's syndrome, thyroid dysfunction, or acromegaly).
  • Pregnant women or those planning pregnancy within 3 months before or after treatment, and women who are breastfeeding.
  • Patients with mental illness, alcohol or drug abuse, who are unable to cooperate with treatment.
  • Known or suspected tumors.
  • History of other autoimmune diseases or hematological disorders.
  • Any other clinical conditions that, in the investigator's judgment, may pose a risk to the participant's safety.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Changzheng Hospital — Shanghai

Identifiers

NCT: NCT06751199 · CZYZ-CTIM-2023-IIT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗