UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes

NCT06751199 | Recruiting

• 1 other identifier: CZYZ-CTIM-2023-IIT
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

• Safety assessment: Registration of adverse events

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

  Throughout the study until Week 52

• Efficacy Assessment: Evaluation of islet function

  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.

  Throughout the study until Week 52

Secondary Outcomes (2)

• Efficacy Assessment: HbA1c

  Week 52

• Dose of exogenous insulin

  Week 52

Study Arms (2)

Experimental

EXPERIMENTAL

allogeneic islet combined with hUCMSCs

Drug: human umbilical cord mesenchymal stem cells; Drug: allogeneic islet

Comparator

ACTIVE COMPARATOR

allogeneic islet

Drug: allogeneic islet

Interventions

human umbilical cord mesenchymal stem cells DRUG

Portal vein infusion human umbilical cord mesenchymal stem cells

Experimental

allogeneic islet DRUG

Portal vein infusion of allogeneic islet

Comparator; Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: December 27, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

CN (1)