A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).

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Overview

A phase 1, open-label safety, tolerability and early efficacy study of a Renal Autologous Cell Therapy (REACT) in patients with Chronic Kidney Disease from Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) (REGEN-004)

It is anticipated that all subjects will receive two planned Renal Autologous Cell Therapy (REACT) injections to allow dose-finding and evaluate the duration of effects. The scientific rationale, based on non-clinical studies, is that the biologically active component of REACT (homologous, autologous, SRC) delays progression of experimental models of Chronic Kidney Disease (CKD) by augmenting renal structure and function. As a result, the more cells that can be infused, the greater the potential improvement in renal function.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease Congenital Anomalies of Kidney and Urinary Tract

Interventions

Renal Autologous Cell Therapy (REACT)BIOLOGICAL

Autologous selected renal cells (SRC)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The patient is male or female, 18 to 65 years of age on the date of informed consent. 2. The patient has a documented history of a corrected abnormality of the kidney and/or urinary tract (CAKUT) leading to renal dysfunction. 3. The patient has an established diagnosis of Stage III/IV CKD not requiring renal dialysis. 4. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Exclusion Criteria: 1. The patient has a history of renal transplantation. 2. The patient has a diagnosis of hydronephrosis, SFU Grade 4 or 5. 3. The patient has an uncorrected VUR Grade 5. 4. The patient has a diffuse cortical thickness throughout the kidney measuring \< 5 mm on MRI that prevents safe cortical biopsy.

Locations (5)

Emory University Hospital

Atlanta, Georgia, United States

Boise Kidney & Hypertension Institute

Meridian, Idaho, United States

Hackensack Meridian Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Mt. Sinai Hospital

New York, New York, United States

Outcomes

Primary Outcomes

Assess change in eGFR and observe incidence of renal-specific procedure and/or product related adverse events (AEs) through 18 months following two Renal Autologous Cell Therapy (REACT) injections [Safety].

The primary objective is to assess the safety and optimal delivery of Renal Autologous Cell Therapy (REACT) injected at one site in a recipient kidney as measured by procedure- and/or product related adverse events (AEs) through 18 months post-treatment.

Time frame: 18 months following last REACT injection

Secondary Outcomes

Number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT).

The number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT) will be observed utilizing renal-specific laboratory assessments.

Time frame: 18 months following last REACT injection

Data from ClinicalTrials.gov

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