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 Renal Autologous Cell Therapy (REACT)/ rilparencel injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with Type1 Diabetes Mellitus (T1DM) or Type2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD):

• Cohort 1: Two scheduled REACT/ rilparencel injections given 3 months (+60 days) with at least 18- month follow-up
• Cohort 2: One scheduled REACT/ rilparencel injection with a possible second REACT/ rilparencel 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 15 months following the first REACT/ rilparencel injection).

Both cohorts will be followed for 18 months after the final REACT/ rilparencel injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.

Inclusion criteria

• Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
• Clinical diagnosis of Type1 Diabetes Mellitus or Type2 Diabetes Mellitus, controlled per institutional standard of care.
• The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).
• The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.
• The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.

Exclusion criteria

• The subject has a history of renal transplantation.
• The subject has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening.

Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor.

• The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for Chronic Kidney Disease-related anemia prior to randomization.