A Study of REGEND003 on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30-75
SponsorRegend Therapeutics
About this trial
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. It is an exploratory study with multi-centered, randomized, controlled, single-blinded, dose-escalated designs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 investigator).
Patients with Type 1 Diabetes Mellitus;
Trial design
Design model
Parallel
Treatments tested in this trial
REGEND003
Biological/VaccineREGEND003
Placebo
Other interventionPlacebo
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: REGEND003Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Event (AE) associated with the Cell Therapy
The incidence and severity of adverse events will be evaluated.
Time frame
Within 24 weeks post-treatmentSecondary outcomes
1
Complications associated with Intrarenal Injection
The incidence will be evaluated.
Time frame
Within 24 weeks post-treatment2
Change from Baseline in Concentration of C-Reactive Protein
C-Reactive Protein is a marker of inflammation in the body.
Time frame
Within 24 weeks post-treatment3
Change from Baseline in Glomerular Filtration Rate (GFR)
GFR is a critical measurement of kidney function, reflecting how efficiently the kidneys filter blood
Time frame
Within 24 weeks post-treatment4
Change from Baseline in Concentration of Serum Creatinine
A creatinine test is a measure of how well the kidneys are doing their job of filtering waste from the blood.
Time frame
Within 24 weeks post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Regend Therapeutics
Lead sponsor
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborator
Source ClinicalTrials.gov