Study of Renal Autologous Cell Therapy (REACT®) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

Study of Renal Autologous Cell Therapy (REACT®) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

The objective of this study is to assess the safety, efficacy, and durability of up to two REACT® injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD:

  • Cohort 1: Two scheduled REACT® injections given 3 months (+60 days) within 24-month follow-up
  • Cohort 2: One scheduled REACT® injection with a possible second REACT® injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 18 months following the first REACT® injection) within 24-month follow-up.

Source: View full study details on ClinicalTrials.gov

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October 8, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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