Diabetic Nephropathy Type 2Phase 1/2NCT07769671
Human Umbilical Cord Mesenchymal Stem Cell Infusion for Type 2 Diabetic Nephropathy
A Phase 1/2 study testing Human umbilical cord mesenchymal stem cell injection in people with Diabetic Nephropathy Type 2, run by The First People's Hospital of Changzhou at 1 site in China.
Trial summary
Diabetic nephropathy (DN) is a chronic kidney disease caused by diabetes. It is one of the most common and most serious microvascular complications of diabetes. Current treatment options for DN are limited. Mesenchymal stem cells (MSCs) are considered one of the promising treatments for DN. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Nephropathy Type 2
- What is being tested?
- Human umbilical cord mesenchymal stem cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Aug 2029
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years, with no gender and ethnicity restrictions.
- Patients who meet the diagnostic criteria for type 2 diabetes mellitus (T2DM) as defined by the Chinese Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus (2020 Edition), with:
- Baseline serum C-peptide concentrations ranging from 0.3 to 3.0 ng/mL;
- Stable antihyperglycemic and antihypertensive medication regimen for at least 3 months prior to screening, defined as dosage adjustment less than 25%.
- Urinary albumin-to-creatinine ratio (UACR) ≥ 30 and ≤ 5000 mg/g together with estimated glomerular filtration rate (eGFR) ≥ 30 and < 90 mL/min/1.73 m².
- Patients are required to have renal biopsy-proven DN glomerulopathy with Tervaert Class IIa to Class III glomerular lesions.
- Patients voluntarily agree to participate and provide written informed consent after full disclosure of the study's purpose, procedures, nature, and potential adverse reactions.
Who cannot join
- Other non-T2DM, such as type 1 diabetes.
- Individuals allergic to MSCs or their preservation solution.
- Individuals with any of the following conditions during screening:
- History of acute diabetic complications within the past 6 months, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis;
- Unstable disease status or severe diabetic complications within the past 6 months, such as proliferative diabetic retinopathy or macular edema, severe diabetic neuropathy, intermittent claudication, active diabetic foot lesions;
- History of three or more Level 3 hypoglycemic events within the past 6 months, as defined by the Guidelines for the Management of Type 2 Diabetes in China (2020 Edition);
Show all 31Show fewer
- History of any of the following cardiac conditions within the past 6 months: decompensated heart failure (New York Heart Association Class III-IV); unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; severe arrhythmias requiring treatment, including second-degree or third-degree atrioventricular block, long QT syndrome, or QTc interval prolongation ≥ 500 ms, and deemed by the investigator to render the subject unsuitable for study participation;
- History of hemorrhagic or ischemic stroke within the past 6 months deemed by the investigator to render the subject unsuitable for study participation;
- History of other severe endocrine disorders affecting glucose metabolism, such as multiple endocrine neoplasia, acromegaly, and Cushing's syndrome, deemed by the investigator to render the subject unsuitable for study participation;
- History of severe digestive system diseases, nutritional and metabolic disorders, or rheumatologic diseases, deemed by the investigator to render the subject unsuitable for study participation;
- Concurrent malignancy or history of malignancy (except malignancies with at least 5 years of disease-free survival);
- Severe psychiatric disorder or speech impairment, or the subject is unwilling or unable to fully understand and comply with study requirements;
- Severe infection or major surgery within the past 6 months, deemed by the investigator to render the subject unsuitable for study participation;
- Acquired Immunodeficiency Syndrome, active hepatitis B, hepatitis C infection, or other acute or chronic infectious diseases;
- Poorly controlled blood pressure, defined as a systolic blood pressure > 180mmHg and/or diastolic blood pressure > 110mmHg.
- Laboratory test results meet the following criteria:
- Alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (ULN);
- Total bilirubin ≥ 2.0 times ULN;
- Currently suffering from severe renal disease, or eGFR (CKD-EPI2012Scr-CysC) < 30 mL/min/1.73 m²;
- Fasting triglycerides > 5.6 mmol/L;
- Serum amylase or serum lipase ≥ 1.5 times ULN;
- Hemoglobin < 10.0 g/dL (100 g/L), serum albumin < 30 g/L;
- Glycosylated hemoglobin ≥ 10%.
- History of long-term systemic corticosteroid administration (consecutive or cumulative ≥ 7 days) within 1 month prior to screening (including but not limited to intravenous administration, oral administration, or intramuscular injection).
- Renal replacement therapy within 3 months prior to screening, current ongoing, or planned initiation within the next 3 months (including hemodialysis, peritoneal dialysis, continuous renal replacement therapy).
- Participation in other drug or device clinical trials within 3 months prior to screening.
- Previous use of other stem cell treatments.
- Use of immunosuppressants, tripterygium glycosides, eplerenone, spironolactone, or similar agents within 3 months prior to screening.
- Pregnancy, lactation, or intention to become pregnant during the study period.
- Any other condition that, in the investigator's judgment, would make the subject unsuitable for the study.
- Renal biopsy revealing DN with coexisting non-DN pathology.
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
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213000
Fei Hua, +86-051968870000, Huafei1970@suda.cn
About this study
Official title: Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection Via Intravenous Infusion in Type 2 Diabetic Nephropathy: A Phase I/IIa Clinical Trial
Diabetic nephropathy (DN) is a chronic kidney disease caused by diabetes. It is one of the most common and most serious microvascular complications of diabetes. Current treatment options for DN are limited. Mesenchymal stem cells (MSCs) are considered one of the promising treatments for DN. This study aims to evaluate the safety, tolerability, and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in patients with type 2 DN.
Read the detailed description
This is a Phase I/IIa clinical trial evaluating the safety, tolerability, and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in patients with type 2 DN. Phase I is a single-center, prospective, open-label, self-controlled study to evaluate the safety and tolerability of MSCs and determine the recommended Phase II dose (RP2D). Phase IIa is a randomized, open-label, standard treatment-controlled study to preliminarily evaluate efficacy.
- Conditions
- Diabetic Nephropathy Type 2
- Being tested
- Human umbilical cord mesenchymal stem cell injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human umbilical cord mesenchymal stem cell injectionBiological
Participants will receive intravenous infusions of allogeneic human umbilical cord MSCs in addition to standard treatment. Phase I will evaluate three dose levels (0.5×10^6/kg, 1.0×10^6/kg and 2.0×10^6/kg). Phase IIa will use dose level 1.0×10^6/kg, subject to adjustment based on Phase I results. Each 6-week treatment cycle will include three infusions administered at 2-week intervals, for a total of three treatment cycles.
| Study group | Role | What they receive |
|---|---|---|
| Phase I MSCs treatment group | Experimental | Patients will receive human umbilical cord mesenchymal stem cells (MSCs) injection in addition to standard treatment (lifestyle management, glycemic control, blood pressure control, urinary protein control, lipid regulation, and uric acid control). Receives: Biological: Human umbilical cord mesenchymal stem cell injection |
| Phase IIa MSCs treatment group | Experimental | Patients will receive MSCs injection in addition to standard treatment (lifestyle management, glycemic control, blood pressure control, urinary protein control, lipid regulation, and uric acid control). Receives: Biological: Human umbilical cord mesenchymal stem cell injection |
| Phase IIa standard treatment control group | No intervention | Patients will receive standard treatment (lifestyle management, glycemic control, blood pressure control, urinary protein control, lipid regulation, and uric acid control). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory tests
AEs and SAEs will be graded according to the NCI-CTCAE version 5.0. Changes in vital signs, ECG, and routine laboratory tests will be monitored throughout the study. The recommended Phase II dose (RP2D) will be determined from Phase I results.
Measured: From enrollment to 6 months after the end of treatment
Phase IIa: Proportion of participants achieving marked response or moderate response to human umbilical cord mesenchymal stem cell injection for type 2 DN
Marked response is defined as significant improvement in clinical symptoms together with complete remission of proteinuria [urinary albumin-to-creatinine ratio (UACR) <30 mg/g], or significant improvement in estimated glomerular filtration rate (eGFR) (serum creatinine reduced by ≥20%). Moderate response is defined as partial alleviation of clinical symptoms and partial remission of proteinuria without complete resolution; either the UACR or 24-hour urinary protein level decreases by ≥50%, or eGFR improves (serum creatinine reduced by ≥10%). No response is defined as no improvement in clinical symptoms and no remission of proteinuria. The reduction of either UACR or 24-hour urinary protein level is less than 50%, and there is no improvement in eGFR (serum creatinine reduced by <10%).
Measured: From enrollment to 6 months after the end of treatment
Secondary outcomes (19)
Phase I: Proportion of participants achieving marked response or moderate response to human umbilical cord mesenchymal stem cell injection for type 2 DN
Marked response is defined as significant improvement in clinical symptoms together with complete remission of proteinuria [UACR<30 mg/g], or significant improvement in eGFR (serum creatinine reduced by ≥20%). Moderate response is defined as partial alleviation of clinical symptoms and partial remission of proteinuria without complete resolution; either the UACR or 24-hour urinary protein level decreases by ≥50%, or eGFR improves (serum creatinine reduced by ≥10%). No response is defined as no improvement in clinical symptoms and no remission of proteinuria. The reduction of either UACR or 24-hour urinary protein level is less than 50%, and there is no improvement in eGFR (serum creatinine reduced by <10%).
Measured: From enrollment to 6 months after the end of treatment
Phase IIa: Incidence and severity of AEs and serious SAEs and clinically significant abnormalities in vital signs, ECG, and laboratory tests
AEs and SAEs will be graded according to the NCI-CTCAE version 5.0. Changes in vital signs, ECG, and routine laboratory tests will be monitored throughout the study.
Measured: From enrollment to 6 months after the end of treatment
Renal function
Changes in serum creatinine, blood urea nitrogen, eGFR
Measured: From enrollment to 6 months after the end of treatment
24-Hour urinary protein quantification
Change in 24-hour urinary protein quantification
Measured: From enrollment to 6 months after the end of treatment
UACR
Change in UACR
Measured: From enrollment to 6 months after the end of treatment
Glycated hemoglobin (HbA1c)
Change in HbA1c
Measured: From enrollment to 6 months after the end of treatment
Fasting blood glucose
Change in fasting blood glucose
Measured: From enrollment to 6 months after the end of treatment
2-Hour postprandial blood glucose
Change in 2-hour postprandial blood glucose
Measured: From enrollment to 6 months after the end of treatment
Fasting insulin
Change in fasting insulin
Measured: From enrollment to 6 months after the end of treatment
Fasting C-Peptide
Change in fasting C-peptide
Measured: From enrollment to 6 months after the end of treatment
Fasting lipid profile
Changes in triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol
Measured: From enrollment to 6 months after the end of treatment
Serum albumin
Change in serum albumin
Measured: From enrollment to 6 months after the end of treatment
Oral glucose tolerance test (OGTT)
Changes in OGTT measurements collected after overnight fasting
Measured: From enrollment to 6 months after the end of treatment
C-peptide release test
Changes in C-peptide release test measurements collected after overnight fasting
Measured: From enrollment to 6 months after the end of treatment
Fasting body weight
Change in fasting body weight
Measured: From enrollment to 6 months after the end of treatment
Body mass index
Body mass index is calculated as weight (kg) divided by height squared (m²), with results in kg/m².
Measured: From enrollment to 6 months after the end of treatment
Waist circumference
Change in waist circumference
Measured: From enrollment to 6 months after the end of treatment
Hip Circumference
Change in hip circumference
Measured: From enrollment to 6 months after the end of treatment
Waist-to-hip ratio
Waist-to-hip ratio is calculated as waist circumference divided by hip circumference, with results as a dimensionless value.
Measured: From enrollment to 6 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Nephropathy Type 2Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769671
- Sponsor's protocol ID
- CZGXB-2022001
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection Via Intravenous Infusion in Type 2 Diabetic Nephropathy: A Phase I/IIa Clinical Trial
- ClinicalTrials.gov ID
- NCT07769671
- Acronym / sponsor ID
- CZGXB-2022001
- Conditions
- Diabetic Nephropathy Type 2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 18 Aug 2026 (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.
Diabetic nephropathy (DN) is a chronic kidney disease caused by diabetes. It is one of the most common and most serious microvascular complications of diabetes. Current treatment options for DN are limited. Mesenchymal stem cells (MSCs) are considered one of the promising treatments for DN. This study aims to evaluate the safety, tolerability, and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in patients with type 2 DN.
Detailed description
This is a Phase I/IIa clinical trial evaluating the safety, tolerability, and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in patients with type 2 DN. Phase I is a single-center, prospective, open-label, self-controlled study to evaluate the safety and tolerability of MSCs and determine the recommended Phase II dose (RP2D). Phase IIa is a randomized, open-label, standard treatment-controlled study to preliminarily evaluate efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I MSCs treatment group | Experimental | Biological: Human umbilical cord mesenchymal stem cell injectionPatients will receive human umbilical cord mesenchymal stem cells (MSCs) injection in addition to standard treatment (lifestyle management, glycemic control, blood pressure control, urinary protein control, lipid regulation, and uric acid control). |
| Phase IIa MSCs treatment group | Experimental | Biological: Human umbilical cord mesenchymal stem cell injectionPatients will receive MSCs injection in addition to standard treatment (lifestyle management, glycemic control, blood pressure control, urinary protein control, lipid regulation, and uric acid control). |
| Phase IIa standard treatment control group | No intervention | –Patients will receive standard treatment (lifestyle management, glycemic control, blood pressure control, urinary protein control, lipid regulation, and uric acid control). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 80 years, with no gender and ethnicity restrictions.
- Patients who meet the diagnostic criteria for type 2 diabetes mellitus (T2DM) as defined by the Chinese Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus (2020 Edition), with:
- Urinary albumin-to-creatinine ratio (UACR) ≥ 30 and ≤ 5000 mg/g together with estimated glomerular filtration rate (eGFR) ≥ 30 and < 90 mL/min/1.73 m².
- Patients are required to have renal biopsy-proven DN glomerulopathy with Tervaert Class IIa to Class III glomerular lesions.
- Patients voluntarily agree to participate and provide written informed consent after full disclosure of the study's purpose, procedures, nature, and potential adverse reactions.
Key exclusion criteria (31 listed)
- Other non-T2DM, such as type 1 diabetes.
- Individuals allergic to MSCs or their preservation solution.
- Individuals with any of the following conditions during screening:
- Laboratory test results meet the following criteria:
- History of long-term systemic corticosteroid administration (consecutive or cumulative ≥ 7 days) within 1 month prior to screening (including but not limited to intravenous administration, oral administration, or intramuscular injection).
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 cell injectionParticipants will receive intravenous infusions of allogeneic human umbilical cord MSCs in addition to standard treatment. Phase I will evaluate three dose levels (0.5×10^6/kg, 1.0×10^6/kg and 2.0×10^6/kg). Phase IIa will use dose level 1.0×10^6/kg, subject to adjustment based on Phase I results. Each 6-week treatment cycle will include three infusions administered at 2-week intervals, for a total of three treatment cycles. | Biological | Phase I MSCs treatment group, Phase IIa MSCs treatment group |
Primary outcome
Phase I: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory tests
Time frame: From enrollment to 6 months after the end of treatment
AEs and SAEs will be graded according to the NCI-CTCAE version 5.0. Changes in vital signs, ECG, and routine laboratory tests will be monitored throughout the study. The recommended Phase II dose (RP2D) will be determined from Phase I results.
Phase IIa: Proportion of participants achieving marked response or moderate response to human umbilical cord mesenchymal stem cell injection for type 2 DN
Time frame: From enrollment to 6 months after the end of treatment
Marked response is defined as significant improvement in clinical symptoms together with complete remission of proteinuria [urinary albumin-to-creatinine ratio (UACR) <30 mg/g], or significant improvement in estimated glomerular filtration rate (eGFR) (serum creatinine reduced by ≥20%). Moderate response is defined as partial alleviation of clinical symptoms and partial remission of proteinuria without complete resolution; either the UACR or 24-hour urinary protein level decreases by ≥50%, or eGFR improves (serum creatinine reduced by ≥10%). No response is defined as no improvement in clinical symptoms and no remission of proteinuria. The reduction of either UACR or 24-hour urinary protein level is less than 50%, and there is no improvement in eGFR (serum creatinine reduced by <10%).
19 secondary outcomes
Phase I: Proportion of participants achieving marked response or moderate response to human umbilical cord mesenchymal stem cell injection for type 2 DN
Time frame: From enrollment to 6 months after the end of treatment
Phase IIa: Incidence and severity of AEs and serious SAEs and clinically significant abnormalities in vital signs, ECG, and laboratory tests
Time frame: From enrollment to 6 months after the end of treatment
Renal function
Time frame: From enrollment to 6 months after the end of treatment
24-Hour urinary protein quantification
Time frame: From enrollment to 6 months after the end of treatment
UACR
Time frame: From enrollment to 6 months after the end of treatment
Glycated hemoglobin (HbA1c)
Time frame: From enrollment to 6 months after the end of treatment
Fasting blood glucose
Time frame: From enrollment to 6 months after the end of treatment
2-Hour postprandial blood glucose
Time frame: From enrollment to 6 months after the end of treatment
Fasting insulin
Time frame: From enrollment to 6 months after the end of treatment
Fasting C-Peptide
Time frame: From enrollment to 6 months after the end of treatment
Fasting lipid profile
Time frame: From enrollment to 6 months after the end of treatment
Serum albumin
Time frame: From enrollment to 6 months after the end of treatment
Oral glucose tolerance test (OGTT)
Time frame: From enrollment to 6 months after the end of treatment
C-peptide release test
Time frame: From enrollment to 6 months after the end of treatment
Fasting body weight
Time frame: From enrollment to 6 months after the end of treatment
Body mass index
Time frame: From enrollment to 6 months after the end of treatment
Waist circumference
Time frame: From enrollment to 6 months after the end of treatment
Hip Circumference
Time frame: From enrollment to 6 months after the end of treatment
Waist-to-hip ratio
Time frame: From enrollment to 6 months after the end of treatment
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 18 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human umbilical cord mesenchymal stem cell injection in people with Diabetic Nephropathy Type 2, run by The First People's Hospital of Changzhou 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 7 inclusion and 31 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: opening soon, as of the sponsor's last update on 18 Aug 2026. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Fei Hua (+86-051968870000, Huafei1970@suda.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory tests (time frame: From enrollment to 6 months after the end of treatment). 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 18 Aug 2026.