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Cell Therapy

Renal Autologous Cell Therapy (REACT) for Chronic Kidney Disease

Phase 1
Waitlist Available
Research Sponsored by Prokidney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months following last react injection
Awards & highlights

Study Summary

This trial is studying the safety and early effectiveness of a cell therapy in people with kidney disease from birth defects.

Eligible Conditions
  • Chronic Kidney Disease
  • Kidney and Urinary Tract Anomalies

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months following last react injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months following last react injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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].
Secondary outcome measures
Number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT).

Trial Design

1Treatment groups
Experimental Treatment
Group I: Renal Autologous Cell Therapy (REACT)Experimental Treatment1 Intervention
The volume of REACT to be administered will be determined by pre-procedure MRI volumetric 3D evaluation or ellipsoid formula. The participant will receive a second injection 6 months after the first injection into the same kidney.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal Autologous Cell Therapy (REACT)
2016
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

ProkidneyLead Sponsor
8 Previous Clinical Trials
1,437 Total Patients Enrolled
CTI Clinical Trial and Consulting ServicesOTHER
34 Previous Clinical Trials
3,729 Total Patients Enrolled
Study DirectorStudy DirectorProkidney
1,207 Previous Clinical Trials
489,674 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current upper limit of participants in this clinical trial?

"For this research to be successful, 15 qualifying individuals must take part. Prokidney will oversee the trial from two sites: Emory University Hospital situated in Atlanta, Georgia and Boise Kidney & Hypertension Institute based in Meridian, Idaho."

Answered by AI

At what locales is the trial currently being conducted?

"Currently, the trial is operating in 4 parts of the country. These are Atlanta, Meridian and Neptune along with an additional quartet of centres. It's best to opt for a location closest to you if you decide to partake in this medical study so as limit transportation needs."

Answered by AI

Is recruiting still open for participation in this trial?

"Yes, records available on clinicaltrials.gov demonstrate that this medical trial is still recruiting participants. It was first published in August 2019 and updated last October 2022. The trial aims to enrol 15 patients across 4 different sites."

Answered by AI

Do I satisfy the criteria for participation in this research?

"This trial is enrolling a cohort of 15 individuals with CKD aged 18-65. Crucially, applicants must meet the following conditions: They are male or female and between 18 and 65 years old; they have renal dysfunction resulting from CAKUT; their stage of CKD does not necessitate dialysis; and lastly, at screening, their blood pressure should be below 150/90 before biopsy or injection(s).."

Answered by AI

What risks do patients face when undergoing REACT - renal autologous cell therapy?

"Our Power team assigned REACT - renal autologous cell therapy a score of 1 for safety, as this Phase 1 trial has yet to yield conclusive evidence on its efficacy and reliability."

Answered by AI

Does this experimentation involve participants aged 75 or over?

"This medical trial stipulates that only those between 18 and 65 years old are eligible for participation. In contrast, 91 clinical studies accept minors while 531 trials accept seniors as their primary demographic."

Answered by AI
~1 spots leftby Apr 2025