REACT (RENAL AUTOLOGOUS CELL THERAPY)
ProKidney has developed a cell-based product called REACT (Renal Autologous Cell Therapy), designed to build renal function in patients with chronically diseased kidneys. REACT is being developed to delay or prevent renal replacement therapy (dialysis or kidney transplant). ProKidney’s REACT is a percutaneous minimally invasive injectable product composed of the patient’s own regenerative renal cells (RRC). Because REACT is a personalized medicine composed of a patient’s own cells, there is no need for immunosuppressive therapy used for a patient’s lifetime for kidney transplant.
In the United States, over 500,000 patients per year suffer from diabetic kidney disease. ProKidney is currently conducting multiple Phase 2 clinical trials for its REACT product. The ProKidney Phase 2 clinical trials are based on a successful internationally conducted Phase 1 clinical trial of the REACT product. Some of the first patients to be injected have been followed for over three years and remain dialysis-free. The trial demonstrated that REACT was well tolerated by patients with moderate to severe diabetic kidney disease.
Expanded Access Policy
- ProKidney is developing Renal Autologous Cell Therapy (REACT) for patients with Chronic Kidney Disease (CKD).
- Consistent with our commitment to bring innovative, safe, and effective therapies to patients, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our therapies available as quickly and safely as possible. Participation in one of our clinical trials is the best and preferred route to access these investigational therapies. We encourage patients interested in our investigational therapies to learn more about our ongoing studies by visiting clinicaltrials.gov.
- “Expanded Access” refers to the use of an investigational therapy outside of a clinical trial for potential treatment of a serious or life-threatening condition.
- ProKidney does not currently provide access to our investigational therapies on an Expanded Access basis.
- In the event ProKidney decides to consider making one or more of its investigational therapy products available to patients who have a serious or life-threatening condition through an Expanded Access Protocol, general criteria to be considered may include:
- Availability of alternative therapies
- The potential risks and benefits to the patient, based on available data and the requesting physician’s assessment of the patient’s condition
- Whether providing expanded access outside of a trial setting will compromise or delay ongoing clinical trials and/or future access by the broader patient community
- Whether there is adequate supply of resources for producing the investigational product to complete ongoing and planned clinical trials
- Whether it is reasonably feasible to provide the investigational product and any necessary follow up outside of the clinical trial setting
- All requests would be evaluated on a case-by-case basis in a fair and equitable manner.
- Treating physicians may request additional information about ProKidney’s Expanded Access policy by contacting our clinical team:
- ProKidney will acknowledge receipt of the inquiry within 5 business days from receipt.
- This policy shall not serve as a guarantee of access to any specific investigational therapy by any individual patient.
- ProKidney reviews its policies from time to time to ensure conformity with applicable laws and regulations. We reserve the right to revise this policy at any time.