A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies RMCL-002, REGEN-003, REGEN-004
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
SUMMARY
The purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (CKD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:
• The participant must have received gelatin-hydrogel formulation REACT in a previous trial (RMCL-002, REGEN-003, REGEN-004) for the treatment of chronic kidney disease and completed an end of study visit in their parent trial per protocol.
Locations
United States
Idaho
Boise Kidney & Hypertension Institute
RECRUITING
Meridian
Contact Information
Primary
Beth Hilburger
info@prokidney.com
336-999-7031
Time Frame
Start Date: 2023-12-11
Estimated Completion Date: 2028-03
Participants
Target number of participants: 80
Treatments
CKD patients previously treated with REACT
Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1).
Related Therapeutic Areas
Sponsors
Leads: Prokidney