REGEND003 treatment for adults with type 2 diabetes and chronic kidney disease
An Exploratory Study of REGEND003 Kidney Progenitor Cells on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
This trial will test whether REGEND003, a therapy made from human kidney progenitor cells, is safe and tolerable in adults with type 2 diabetes and chronic kidney disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Regend Therapeutics Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07275788 on ClinicalTrials.gov |
What this trial studies
This Phase 1, multicenter, randomized, placebo-controlled, single-blinded, dose-escalation trial tests the safety and tolerability of REGEND003 in adults with T2DM and CKD. Participants aged 30–75 with at least one year of type 2 diabetes and diagnosed chronic kidney disease will be randomized to receive REGEND003 or placebo and followed with clinical and laboratory monitoring. The study excludes pregnant or nursing participants and those positive for treponema pallidum antibody, HIV, or active hepatitis B or C markers (stable hepatitis B carriers and cured HCV with negative RNA may be eligible), and requires informed consent and ability to comply with procedures. Regend Therapeutics sponsors the trial with Shanghai Tongji Hospital serving as a study site.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30–75 with type 2 diabetes for at least one year and diagnosed chronic kidney disease who can provide informed consent and attend study procedures.
Not a fit: People who are pregnant, nursing, planning pregnancy within a year, or who test positive for TP, HIV, or active hepatitis B or C are unlikely to participate or receive benefit from this trial.
Why it matters
Potential benefit: If successful, REGEND003 could help repair kidney injury and slow progression of CKD in people with type 2 diabetes, potentially delaying the need for dialysis.
How similar studies have performed: Cell-based kidney progenitor therapies have shown promising results in preclinical models and early-phase work, but clear clinical benefits in larger human trials remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 compliance. Exclusion Criteria: * 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. Hepatitis B virus carriers with stable current condition can be enrolled. Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test can be enrolled as well. * 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 investigator). * 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 transplantation at screening; * 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.
Where this trial is running
Shanghai
- Shanghai Tongji Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Prof. Yu
- Email: yuchen@tongji.edu.cn
- Phone: 086-021-66111062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.