A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease

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

Inclusion criteria

for Study Part 1:

• The subject is male or female, 30 to 80 years of age on the date of informed consent.
• The subject has an established diagnosis of Type 2 Diabetes Mellitus.
• The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
• The subject has an established diagnosis of Chronic Kidney Disease not requiring renal dialysis, defined as having an Estimated Glomerular Filtration Rate (eGFR) between 20 and 50 mL/min/1.73m².
• The subject has blood pressure less than 150/90 at the Screening Visit.
• The subject has stable blood pressure and is maintained on a stable anti-hypertensive medication regimen.
• A minimum of 2 measurements of Estimated Glomerular Filtration Rate (eGFR) or serum creatine ratio (sCr) should be obtained at least 3 months apart prior to the Screening Visit or within the previous 18 months to define the rate of progression of Chronic Kidney Disease (CKD).

Exclusion criteria

for Study Part 1:

• The subject has a history of type 1 diabetes mellitus.
• The subject has a history of renal transplantation.
• The subject has a serum Hemoglobin A1c (HbA1c) level greater than 10% at the Screening Visit.
• The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
• The subject has hemoglobin levels less than 9 g/dL prior to each Renal Autologous Cell Therapy (REACT) injection.

Inclusion criteria

for Study Part 2:

• The subject is willing and able to provide signed informed consent.
• The subject was enrolled into Part 1 of the study and received at least one Renal Autologous Cell Therapy (REACT) injection.

Exclusion criteria

for Study Part 2:

• The subject is currently receiving renal dialysis.