Actively Recruiting
Study of Dose Escalation and Expansion for Safety and Effects of Human Umbilical Cord Mesenchymal Stem Cells Combined with Allogeneic Islet Transplantation to Treat 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
Researchers are evaluating the safety and effectiveness of combining allogeneic human umbilical cord mesenchymal stem cells with allogeneic islet transplantation to treat diabetes. This study includes adults aged 18 to 70 who have diabetes characterized by islet function failure and poor blood glucose control despite treatment. The trial aims to preserve the body's own insulin production and improve metabolic control, diabetes treatment satisfaction, and immunological outcomes. The trial has two parts: the first is an open-label dose-escalation phase with 9 participants, and the second is a non-randomized, active comparator-controlled phase comparing the combined stem cell and islet transplantation treatment to islet transplantation alone. Both treatments are delivered via portal vein infusion. Participants receive either the combination of stem cells and islets or islets alone, and the study evaluates safety and efficacy up to 52 weeks. Participants undergo ongoing safety monitoring with the registration of adverse events throughout the 52-week study period. Effectiveness is assessed by measuring islet function, including C-peptide levels, along with metabolic control and patient satisfaction. The total duration of participation spans up to one year, during which clinical, immunological, and metabolic evaluations are conducted to assess treatment outcomes and safety.
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.
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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
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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