To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach in participants with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD).
Study Part 1: Multi-center, prospective, open-label, randomized, double-arm, deferred treatment study whereby eligible subjects will be randomized 1:1 after kidney biopsy to receive up to 2 injections of REACT (made from expanded autologous selected renal cells) into the biopsied kidney beginning as soon as REACT can be prepared, or the same series of up to 2 injections given 6 months (+4 weeks) apart beginning 12 months after renal biopsy. Subjects will be followed through 23 months after the last injection. Study Part 2: An open-label extension study in which eligible subjects will be followed for an additional 36 months of long-term follow-up. Subjects will be able to roll from Study Part 2 into a Long Term Follow-Up Master protocol for up to 5 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
Autologous selected renal cells (SRC).
a procedure in which a small sample of kidney tissue is removed
University of Arizona
Tucson, Arizona, United States
Kidney Associates of Colorado
Denver, Colorado, United States
Change in Renal Function
Serial measurements of estimated glomerular filtration rate (eGFR) obtained pre-randomization and at three-month intervals through 24 months after the last REACT injection in the active treatment group and at least 12 months post last REACT injection in the deferred treatment group.
Time frame: Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm
Treatment emergent adverse events
Treatment emergent adverse events, serial safety laboratory results
Time frame: Through 24 months following last REACT injection for the active arm and at least 12 months following the last REACT injection for the deferred arm
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Yale Univeristy
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Boise Kidney and Hypertension Institute
Meridian, Idaho, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Paragon Health
Kalamazoo, Michigan, United States
...and 6 more locations