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

A Phase 2, Randomized, Open-Labeled, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

The purpose 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).

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:

1. Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
2. Clinical diagnosis of Type1 Diabetes Mellitus or Type2 Diabetes Mellitus, controlled per institutional standard of care.
3. 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).
4. The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.
5. 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:

1. The subject has a history of renal transplantation.

2. 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.

3. 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.