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A Phase 3 Randomized Controlled Study Of Renal Autologous Cell Therapy (React) In Subjects With Type 2 Diabetes And Chronic Kidney Disease (REGEN-006)<\/i><\/span> Background: REACT is an investigational cell-based advanced therapy product composed of selected renal cells naturally involved in renal repair and regeneration. 1\u20133 Biopsied renal cells obtained from patients are expanded ex vivo to form the active biological ingredient of the REACT product. REACT is then injected into the patient\u2019s renal cortex using image-guided non-cutting percutaneous needle injection. This study will evaluate whether 2 REACT injections given 3 months apart into contralateral kidneys can stabilize, prevent, or delay renal function decline in patients with T2DM and CKD.<\/span> [\/et_pb_text][et_pb_text _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Study eligibility will be determined.<\/span><\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Assessments include, but are not limited to, physical examination, vital signs, electrocardiogram, renal imaging, blood tests, and questionnaires.<\/span><\/p>\n Biopsy visits<\/strong><\/span><\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Eligible participants will be randomized 1:1 to 1 of the 2 cohorts.<\/span><\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Participants in Cohort 1 will have a scripted, simulated (fake) biopsy under conscious sedation during which no tissue will be taken. They will also undergo 2 scripted, simulated injection procedures.<\/span><\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Participants in Cohort 2 will have a biopsy and receive 2 REACT injections.<\/span><\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Only participants will be blinded to the study injection assignment.<\/span><\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Participants will have a telephone follow-up visit 1 day after the biopsy.<\/span><\/p>\n Injection visits<\/strong><\/span><\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 The first study injection will be administered in the biopsied kidney 12 weeks after the biopsy.<\/span><\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Participants will have 4 follow-up study center visits for 10 weeks after the first study injection.<\/span><\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 The second study injection will be administered 3 months after the first study injection in the non-biopsied contralateral kidney.<\/span><\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Participants will have 3 follow-up study center visits for 1 month after the second study injection.<\/span><\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Participants in the simulated cohort will receive simulated (fake) injections under conscious sedation.<\/span><\/p>\n Long-term follow-up period<\/strong><\/span><\/p>\n \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Participants will have follow-up visits every 3 months, starting 6 months after the first study injection, until the Global Trial End Date.<\/span><\/p>\n<\/div>\n [\/et_pb_text][et_pb_image src=”https:\/\/www.washingtonnephrology.com\/wp-content\/uploads\/2023\/03\/Picture1.png” title_text=”Picture1″ _builder_version=”4.20.2″ _module_preset=”default” module_alignment=”center” max_height=”1000px” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”]<\/p>\nKey Inclusion Criteria<\/strong><\/span><\/h3>\n
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Key Exclusion Criteria<\/strong><\/span><\/h3>\n
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