🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06751199
Recruiting Not applicable

UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes

NCT06751199 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Changzheng Hospital
Phase
Not applicable
Started
2024-12-30
Last updated
2024-12-27

Condition(s) studied

Diabetes

Investigational drug(s) / intervention(s)

human umbilical cord mesenchymal stem cells →allogeneic islet

human umbilical cord mesenchymal stem cells: Portal vein infusion human umbilical cord mesenchymal stem cells

allogeneic islet: Portal vein infusion of allogeneic islet

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Changzheng Hospital Shanghai Shanghai Municipality Recruiting

More Shanghai Changzheng Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06751199 on ClinicalTrials.gov ↗ ← All trials in China