UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes

Not Applicable

Recruiting

• Conditions: Diabetes
• Interventions: Drug: human umbilical cord mesenchymal stem cells; Drug: allogeneic islet

• Registration Number: NCT06751199
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

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.

Study Timeline

• Study First Submitted: 2024-10-10
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2024-12-30
• Primary Completion: 2026-07-30
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Meets the 1999 World Health Organization diagnostic criteria for diabetes.

2. Aged 18-70, no gender restriction.

3. Islet function failure: fasting C-peptide < 0.1 nmol/L, 2-hour postprandial C-peptide < 0.2 nmol/L, and HbA1c ≥ 7%.

4. 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.

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	human umbilical cord mesenchymal stem cells	allogeneic islet combined with hUCMSCs
Experimental	allogeneic islet	allogeneic islet combined with hUCMSCs
Comparator	allogeneic islet	allogeneic islet

Primary Outcome Measures

Name	Time	Method
Safety assessment: Registration of adverse events	Throughout the study until Week 52	Changes in safety parameters of patients during the study period since baseline. Measured through the registration of adverse events.
Efficacy Assessment: Evaluation of islet function	Throughout the study until Week 52	Change of C-peptide Area Under the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at Week 52 compared to test performed before start of treatment.

Secondary Outcome Measures

Name	Time	Method
Efficacy Assessment: HbA1c	Week 52	Changes in patient HbA1c levels from baseline during the study period
Dose of exogenous insulin	Week 52	Changes in daily exogenous insulin requirements during the study period

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China