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New treatment option for Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
Official title A Study of REGEND003 on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
ClinicalTrials.gov ID: NCT07275788
What this study is testing
What is REGEND003?
REGEND003 is an investigational medicine, being studied as a potential treatment for type 2 diabetes mellitus (t2dm) and chronic kidney disease (ckd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- REGEND003, which consists of human kidney progenitor cells, demonstrates promising potential in repairing kidney injury. The purpose of this study is to assess the saftey and tolerability of REGEND003 on patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75
You may be able to join if
- Male or female, aged 30 to 75 years at the time of signing the informed consent form;
- Diagnosed with Type 2 Diabetes Mellitus for at least 1 year;
- Diagnosed with Chronic Kidney Disease (CKD);
- Voluntarily sign the informed consent form, be able to cooperate in completing study-related procedures and examinations, capable of adequately...
You likely can't join if
- Females who are pregnant, nursing, or planning to be pregnant within a year after using this product (or males whose spouse planning to be pregnant);
- At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody...
- Presence of a current or prior history of malignant tumor at screening (with the exception of those with disease-free survival for more than 2 years...
- Patients with Type 1 Diabetes Mellitus;
- Patients undergoing regular hemodialysis or peritoneal dialysis;
- Presence of severe acute complications of diabetes or CKD requiring hospitalization within 2 weeks prior to screening;
See the full eligibility criteria
- Male or female, aged 30 to 75 years at the time of signing the informed consent form;
- Diagnosed with Type 2 Diabetes Mellitus for at least 1 year;
- Diagnosed with Chronic Kidney Disease (CKD);
- Voluntarily sign the informed consent form, be able to cooperate in completing study-related procedures and examinations, capable of adequately recording or describing changes in their condition, and demonstrate strong...
- Females who are pregnant, nursing, or planning to be pregnant within a year after using this product (or males whose spouse planning to be pregnant);
- At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test...
- Presence of a current or prior history of malignant tumor at screening (with the exception of those with disease-free survival for more than 2 years, or malignancies deemed to be of low aggressiveness as assessed by the...
- Patients with Type 1 Diabetes Mellitus;
- Patients undergoing regular hemodialysis or peritoneal dialysis;
- Presence of severe acute complications of diabetes or CKD requiring hospitalization within 2 weeks prior to screening;
- Presence of more than one episode of hypoglycemic coma (blood glucose ≤3.9 mmol/L) within 1 month prior to screening;
- Patients intolerant to renal puncture/intrarenal injection procedures;
- Patients with diagnosis of acute kidney injury, congenital or hereditary kidney diseases, renal atrophy, or other renal conditions deemed ineligible by the investigator, as well as patients with a history of kidney...
- Presence of severe systemic diseases within 6 months prior to screening and judged by the investigator as unsuitable for the study;
- Patients requiring long-term anticoagulant or antiplatelet therapy who, in the investigator's judgment, cannot discontinue medication 1 week prior to renal puncture/intrarenal injection procedures;
- Patients with suicidal risk, history of psychiatric disorders, or history of epilepsy at screening;
- Patients with severe arrhythmias or heart conduction disorders (degree II or above) in 12-lead ECG test at screening;
- Patients participated in other clinical trials with interventions within 1 month prior to screening;
- Subject with assessed survival time of less than 1 year by investigators at screening;
- Investigators, co-investigators, study coordinators, employees of participating investigators or research centers, or family members of the above individuals;
- Any condition that, in the investigator's judgment, may increase subject risk or interfere with the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.