Combining stem cells with islet transplantation to treat diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of infusing allogeneic human umbilical cord mesenchymal stem cells (hUCMSCs) alongside allogeneic islet transplantation for diabetes treatment. The study consists of two parts: an open-label, dose-escalation phase involving 9 patients aged 18 to 70, and a non-randomized, active comparator-controlled phase comparing the combined treatment to islet transplantation alone. Key outcomes include safety, preservation of endogenous insulin production, metabolic control, diabetes treatment satisfaction, and immunological profiles.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Changzheng Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Hao Yin — Shanghai Changzheng Hospital
• Study coordinator: Hao Yin
• Email: yinhaoshanghai@163.com
• Phone: 13901677738

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.