Renal Autologous Cell Therapy for Chronic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the long-term safety of a treatment called REACT for individuals with chronic kidney disease (CKD). REACT involves injecting a special gelatin-hydrogel formulation into the kidney to observe its effects on kidney function over time. The study targets individuals who previously received REACT in an earlier clinical trial for CKD. Participants must have completed their previous study and are now monitored to ensure the treatment's continued safety. As a Phase 4 trial, this study highlights that REACT is already FDA-approved and proven effective, aiming to understand how the treatment benefits more patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for the REACT injections?
Research has shown that Renal Autologous Cell Therapy (REACT) is generally safe and well-tolerated. Studies have found that patients receiving REACT injections experienced few serious side effects. In one study, the therapy did not significantly slow chronic kidney disease in some patients, but it did not cause major safety issues either. Another report showed promising early results, indicating that the therapy can help maintain kidney function in patients at moderate and high risk of kidney disease without causing significant harm. This evidence suggests that REACT is relatively safe, with manageable side effects.12345
Why are researchers enthusiastic about this study treatment?
Unlike traditional treatments for chronic kidney disease (CKD), which often involve medication or dialysis to manage symptoms, Renal Autologous Cell Therapy (REACT) is unique because it uses a patient's own cells to potentially repair damaged kidney tissue. This approach aims to restore kidney function rather than just alleviate symptoms. Researchers are excited about REACT because it represents a regenerative strategy, offering hope for a more sustainable and long-term solution for CKD patients. This therapy could significantly change how we approach kidney disease treatment by addressing the root cause rather than just the symptoms.
What evidence suggests that REACT injections are effective for chronic kidney disease?
Research has shown that Renal Autologous Cell Therapy (REACT) could help treat chronic kidney disease (CKD). Studies have found that this treatment can slow the decline in kidney function by using the patient's own cells to repair and support damaged kidney areas. Some patients have experienced improved kidney function, potentially delaying the need for dialysis or a kidney transplant. Early results suggest that REACT could be particularly beneficial for individuals with CKD related to diabetes. This trial will include CKD patients previously treated with REACT in earlier studies.12456
Who Is on the Research Team?
Study Director
Principal Investigator
Prokidney
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to two REACT injections given 3 to 6 months apart
Long-term Follow-up
Participants are monitored for long-term safety and renal function with alternating in-clinic and phone visits
What Are the Treatments Tested in This Trial?
Interventions
- REACT
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Prokidney
Lead Sponsor
Citations
Rilparencel (Renal Autologous Cell Therapy-REACT®) for ...
Autologous cell-based therapies (CBT) to treat chronic kidney disease (CKD) with diabetes are novel and can potentially preserve renal function and decelerate ...
NCT05018416 | Study of Renal Autologous Cell Therapy ...
The purpose of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non- ...
WCN23-0428 RENAL AUTOLOGOUS CELL THERAPY ...
Cell-based therapies may repair diseased nephrons and stabilize and enhance kidney function to delay the onset of end-stage kidney disease and improve ...
Rilparencel autologous cell therapy preserved kidney ...
The treatment could potentially delay disease progression for the many diabetes patients with chronic kidney disease who progress to kidney ...
5.
investors.prokidney.com
investors.prokidney.com/news-releases/news-release-details/prokidney-announces-positive-interim-data-rmcl-002-phase-2ProKidney Announces Positive Interim Data from RMCL ...
Updated positive interim Phase 2 data demonstrate potential efficacy of REACT to preserve kidney function in moderate and high-risk diabetic CKD patients.
PHASE II TRIAL WITH BILATERAL CORTEX INJECTIONS ...
Cell-based therapies may repair diseased nephrons and stabilize and enhance kidney function to delay the onset of end-stage kidney disease and improve ...
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