DiabetesNCT06751199
UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes
A study testing human umbilical cord mesenchymal stem cells and allogeneic islet in people with Diabetes, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- human umbilical cord mesenchymal stem cells and allogeneic islet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets the 1999 World Health Organization diagnostic criteria for diabetes.
- Aged 18-70, no gender restriction.
- Islet function failure: fasting C-peptide < 0.1 nmol/L, 2-hour postprandial C-peptide < 0.2 nmol/L, and HbA1c ≥ 7%.
- Meets the indications for islet transplantation alone:
- 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.
- The patient and their family or legal guardian voluntarily consent to stem cell transplantation therapy and sign the informed consent form.
Who cannot join
- Diabetic ketoacidosis that is not yet controlled.
- Severe allergic constitution, meaning prone to allergic reactions without a clear and identifiable cause.
- BMI < 14 or > 35.
- Severe anemia (hemoglobin < 8 g/dL in males, < 7 g/dL in females).
- HIV-positive, carriers of viral hepatitis or in the active phase, or other uncontrolled infectious diseases.
- History of acute pancreatitis, pulmonary embolism, or other thrombotic diseases, as well as severe heart, liver, kidney, respiratory, or neurological diseases.
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- 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).
- Pregnant women or those planning pregnancy within 3 months before or after treatment, and women who are breastfeeding.
- Patients with mental illness, alcohol or drug abuse, who are unable to cooperate with treatment.
- Known or suspected tumors.
- History of other autoimmune diseases or hematological disorders.
- Any other clinical conditions that, in the investigator's judgment, may pose a risk to the participant's safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Hao Yin, 13901677738, yinhaoshanghai@163.com
About this study
Official title: 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
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
Read the detailed description
This is an investigator-initiated trial (IIT). The first part is an open-label, dose-escalation study involving 9 patients between the ages of 18 and 70. The second part is a non-randomized, active comparator-controlled IIT with a parallel design, comparing allogeneic islet transplantation combined with human umbilical cord mesenchymal stem cells (hUCMSCs) to allogeneic islet transplantation alone in patients with diabetes.Besides safety, preservation of endogenous insulin production (measured as C-peptide concentrations) together with metabolic control, diabetes treatment satisfaction and immunological profile will be assessed.
- Conditions
- Diabetes
- Being tested
- human umbilical cord mesenchymal stem cells, allogeneic islet
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human umbilical cord mesenchymal stem cellsDrug
Portal vein infusion human umbilical cord mesenchymal stem cells
allogeneic isletDrug
Portal vein infusion of allogeneic islet
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | allogeneic islet combined with hUCMSCs Receives: Drug: human umbilical cord mesenchymal stem cells; Drug: allogeneic islet |
| Comparator | Active comparator | allogeneic islet Receives: Drug: allogeneic islet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment: Registration of adverse events
Changes in safety parameters of patients during the study period since baseline. Measured through the registration of adverse events.
Measured: Throughout the study until Week 52
Efficacy Assessment: Evaluation of islet function
Change of C-peptide Area Under the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at Week 52 compared to test performed before start of treatment.
Measured: Throughout the study until Week 52
Secondary outcomes (2)
Efficacy Assessment: HbA1c
Changes in patient HbA1c levels from baseline during the study period
Measured: Week 52
Dose of exogenous insulin
Changes in daily exogenous insulin requirements during the study period
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Yin, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751199
- Sponsor's protocol ID
- CZYZ-CTIM-2023-IIT
- Status last verified
- Dec 2024
- First submitted
- 10 Oct 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06751199
- Acronym / sponsor ID
- CZYZ-CTIM-2023-IIT
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is an investigator-initiated trial (IIT). The first part is an open-label, dose-escalation study involving 9 patients between the ages of 18 and 70. The second part is a non-randomized, active comparator-controlled IIT with a parallel design, comparing allogeneic islet transplantation combined with human umbilical cord mesenchymal stem cells (hUCMSCs) to allogeneic islet transplantation alone in patients with diabetes.Besides safety, preservation of endogenous insulin production (measured as C-peptide concentrations) together with metabolic control, diabetes treatment satisfaction and immunological profile will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: human umbilical cord mesenchymal stem cells, Drug: allogeneic isletallogeneic islet combined with hUCMSCs |
| Comparator | Active comparator | Drug: allogeneic isletallogeneic islet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meets the 1999 World Health Organization diagnostic criteria for diabetes.
- Aged 18-70, no gender restriction.
- Islet function failure: fasting C-peptide < 0.1 nmol/L, 2-hour postprandial C-peptide < 0.2 nmol/L, and HbA1c ≥ 7%.
- Meets the indications for islet transplantation alone:
- The patient and their family or legal guardian voluntarily consent to stem cell transplantation therapy and sign the informed consent form.
Key exclusion criteria (12 listed)
- Diabetic ketoacidosis that is not yet controlled.
- Severe allergic constitution, meaning prone to allergic reactions without a clear and identifiable cause.
- BMI < 14 or > 35.
- Severe anemia (hemoglobin < 8 g/dL in males, < 7 g/dL in females).
- HIV-positive, carriers of viral hepatitis or in the active phase, or other uncontrolled infectious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human umbilical cord mesenchymal stem cellsPortal vein infusion human umbilical cord mesenchymal stem cells | Drug | Experimental |
| allogeneic isletPortal vein infusion of allogeneic islet | Drug | Comparator, Experimental |
Primary outcome
Safety assessment: Registration of adverse events
Time frame: Throughout the study until Week 52
Changes in safety parameters of patients during the study period since baseline. Measured through the registration of adverse events.
Efficacy Assessment: Evaluation of islet function
Time frame: Throughout the study until Week 52
Change of C-peptide Area Under the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at Week 52 compared to test performed before start of treatment.
2 secondary outcomes
Efficacy Assessment: HbA1c
Time frame: Week 52
Dose of exogenous insulin
Time frame: Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hao Yin principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human umbilical cord mesenchymal stem cells and allogeneic islet in people with Diabetes, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Yin (13901677738, yinhaoshanghai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment: Registration of adverse events (time frame: Throughout the study until Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.