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

Study Overview
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Brief Summary
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To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach in participants with T2DM and CKD.

Detailed Description
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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.

Official Title
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A Phase 2 Prospective, Randomized, Double-Arm, Deferred Treatment, Open Label, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease

Conditions
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Type 2 Diabetes Mellitus, Chronic Kidney Disease

Intervention / Treatment
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* Biological: Renal Autologous Cell Therapy (REACT)


Participation Criteria
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Eligibility Criteria
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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 T2DM. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease. The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an 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 eGFR or 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 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 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 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 REACT injection. Exclusion Criteria for Study Part 2: 1. The subject is currently receiving renal dialysis.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment<br>Renal Autologous Cell Therapy (REACT) immediate treatment - Patients who are randomized to receive their first treatment of 2 injections of REACT as soon as REACT product is made available. | Biological: Renal Autologous Cell Therapy (REACT)<br>* Autologous selected renal cells (SRC).<br>|
| Active Comparator: Delayed Treatment<br>Renal Autologous Cell Therapy (REACT) delayed treatment - Patients who are randomized to receive standard of care treatment for the first 12 months after REACT product is made available before receiving 2 injections of REACT. | Biological: Renal Autologous Cell Therapy (REACT)<br>* Autologous selected renal cells (SRC).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Renal Function | eGFR at 24 months after last REACT injection | Through 24 months following last REACT injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment emergent adverse events | Treatment emergent adverse events, serial safety laboratory results | Through 24 months following last REACT injection |