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UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes

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

NCT06751199•Shanghai Changzheng Hospital

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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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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.
+2 more criteria

Locations (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

December 30, 2024

Primary Completion Date

July 30, 2026

Completion Date

December 1, 2026

Last Updated

December 27, 2024

Enrollment

ESTIMATED participants

Conditions

Diabetes

Interventions

human umbilical cord mesenchymal stem cells

DRUG

allogeneic islet

DRUG

Contacts

Hao Yin

CONTACT

13901677738 yinhaoshanghai@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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