A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease

Study Overview
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Brief Summary
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The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).

Detailed Description
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All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.

Official Title
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A Phase II, Open-Label Safety and Tolerability Study of an Renal Autologous Cell Therapy (REACT) in Patients With Type 2 Diabetes and Chronic Kidney Disease (REGEN-003)

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: The subject is male or female, 30 to 65 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 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and prior to REACT injection. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Note BP should not be significantly below the previously recorded stable pressure. A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Autologous Cell Therapy (REACT)<br>Renal Autologous Cell Therapy (REACT) Treatment - Patients will 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure and/or product related adverse events | Incidence (percentage of subjects) with procedure and/or product related adverse events by System Order Class and Preferred Term | Through 24 months following last REACT injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal specific adverse events | Incidence (percentage of subjects) with renal-specific adverse events by System Order Class and Preferred Term | Through 24 months following last REACT injection |