Actively Recruiting
UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes
Led by Shanghai Changzheng Hospital · Updated on 2024-12-27
16
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets the 1999 World Health Organization diagnostic criteria for diabetes.
- Aged 18 to 70 years, any gender.
- Islet function failure defined as fasting C-peptide < 0.1 nmol/L, 2-hour postprandial C-peptide < 0.2 nmol/L, and HbA1c 7%.
- For type 1 diabetes patients with unstable blood glucose despite strict insulin therapy, including frequent hypoglycemia or at least one severe hypoglycemic event in the past 12 months, or serious complications in other organs.
- For type 2 diabetes patients progressing to islet failure with poor blood glucose control.
- Patients with chronic pancreatitis or non-malignant pancreatic tumors who have undergone total or near-total pancreatectomy may receive autologous or allogeneic islet transplantation.
- Patient and family or legal guardian voluntarily consent to stem cell transplantation therapy and sign informed consent form.
You will not qualify if you...
- Uncontrolled diabetic ketoacidosis.
- Severe allergic constitution prone to unexplained allergic reactions.
- Body mass index (BMI) below 14 or above 35.
- Severe anemia (hemoglobin < 8 g/dL in males, < 7 g/dL in females).
- HIV-positive, viral hepatitis carriers or active infection, or other uncontrolled infections.
- History of acute pancreatitis, pulmonary embolism, thrombotic diseases, or severe heart, liver, kidney, respiratory, or neurological diseases.
- Gestational diabetes, monogenic diabetes, pancreatic damage-related diabetes, or other secondary diabetes causes.
- Pregnant women, those planning pregnancy within 3 months before or after treatment, or breastfeeding women.
- Mental illness, alcohol or drug abuse preventing cooperation with treatment.
- Known or suspected tumors.
- History of other autoimmune diseases or blood disorders.
- Any other clinical condition posing risk to participant safety as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
H
Hao Yin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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