Combining stem cells with islet transplantation to treat diabetes

Investigation of Dose Escalation and Dose Expansion Study on the Safety and Efficacy of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes

This study is testing if adding stem cells to islet transplantation can improve diabetes treatment for adults aged 18 to 70.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Changzheng Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06751199 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-70 with type 1 or type 2 diabetes experiencing islet function failure and unstable blood glucose control.

Not a fit: Patients with diabetes who do not meet the specific criteria for islet transplantation or those with stable blood glucose control may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve insulin production and metabolic control in diabetes patients, potentially reducing their dependence on insulin therapy.

How similar studies have performed: While the combination of stem cells and islet transplantation is a novel approach, similar studies have shown promise in improving outcomes for diabetes patients.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Hao Yin — Shanghai Changzheng Hospital
• Study coordinator: Hao Yin

Conditions Diabetes