A Study of Participants With Chronic Kidney Disease Previously Treated With REACT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-11

Study Completion Date

2024-05-13

Brief Summary

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The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.

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Detailed Description

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A Phase 1, Open-label trial where up to 10 participants will enroll in the trial after parent REACT protocol EOS visit completion. Participants may undergo a biopsy to manufacture REACT if additional biopsy tissue is required. Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.

Conditions

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Diabetic Kidney Disease CAKUT Chronic Kidney Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal Autologous Cell Therapy (REACT)

Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.

Group Type EXPERIMENTAL

Renal Autologous Cell Therapy (REACT)

Intervention Type BIOLOGICAL

Autologous selected renal cells (SRC)

Interventions

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Renal Autologous Cell Therapy (REACT)

Autologous selected renal cells (SRC)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. The participant has received REACT in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period.
2. The participant is male or female, 30 to 80 years of age on the date of informed consent.
3. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 14 and less than or equal to 50 mL/min/1.73m2, not requiring renal dialysis.
4. The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary.

Exclusion Criteria

1. The participant has a history of renal transplantation.
2. The participant has received dialysis for more than 30 days.
3. The participant has received any other investigational products after completion of REACT injections within 3 months of screening.
4. The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than 5,000 mg/g.
5. The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to screening.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No