UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes
NCT ID: NCT06751199
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
16 participants
INTERVENTIONAL
2024-12-30
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental
allogeneic islet combined with hUCMSCs
human umbilical cord mesenchymal stem cells
Portal vein infusion human umbilical cord mesenchymal stem cells
allogeneic islet
Portal vein infusion of allogeneic islet
Comparator
allogeneic islet
allogeneic islet
Portal vein infusion of allogeneic islet
Interventions
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human umbilical cord mesenchymal stem cells
Portal vein infusion human umbilical cord mesenchymal stem cells
allogeneic islet
Portal vein infusion of allogeneic islet
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
Yes
Sponsors
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Shanghai Changzheng Hospital
OTHER
Responsible Party
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Principal Investigators
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Hao Yin
Role: PRINCIPAL_INVESTIGATOR
Shanghai Changzheng Hospital
Locations
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Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Hao Yin
Role: primary
Other Identifiers
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CZYZ-CTIM-2023-IIT
Identifier Type: -
Identifier Source: org_study_id