Overview

STUDY OF RENAL AUTOLOGOUS CELL THERAPY (REACT) IN SUBJECTS WITH TYPE 1 or 2 DIABETES AND CHRONIC KIDNEY DISEASE (REGEN-007)

Status:
Recruiting
Trial end date:
2025-05-20
Target enrollment:
Participant gender:
Summary
Multi-center, prospective, open-label, double-arm, randomized, redose study whereby eligible subjects will be randomized 1:1 after kidney biopsy to 1 of 2 cohorts. Cohort 1 subjects will receive 2 REACT injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days). Cohort 2 subjects will receive 1 REACT injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT injection into the contralateral kidney. Both cohorts will be followed for 24 months after the final REACT injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for 24 months after the first injection.
Phase:
Phase 2
Details
Lead Sponsor:
Prokidney