The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).
All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Autologous selected renal cells (SRC)
University of Arizona [WITHDRAWN]
Tucson, Arizona, United States
Boise Kidney & Hypertension Institute
Boise, Idaho, United States
University of North Carolina- Chapel Hill
Chapel Hill, North Carolina, United States
Vanderbilt University [WITHDRAWN]
Nashville, Tennessee, United States
Procedure and/or Product Related Adverse Events
Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term
Time frame: Through 24 months following last REACT injection
Renal Specific Adverse Events
Percentage of subjects with renal-specific adverse events by System Order Class and Preferred Term
Time frame: Through 24 months following last REACT injection
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