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Clinical Trials

Through its unique and integrated technology platform, RegenMedTX is researching and developing product candidates with the potential to transform the treatment of organ and tissue impairment, failure and loss. The Company’s clinical development plan is to manufacture, and market a suite of autologous cell therapy products.

Chronic Kidney Disease is characterized by progressive nephropathy that without therapeutic intervention will worsen until the patient reaches end stage renal disease (ESRD).  Worldwide, the incidence and prevalence of CKD and ESRD are increasing while therapeutic outcomes remain poor (ERA, 2009; USRDS, 2011).  The greatest cause of ESRD in Europe, including Sweden, is diabetes mellitus, and the incidence of CKD in Europe continues to increase, primarily due to the increases in the incidence of type 2 diabetes (Postma and de Zeeuw, 2009).  CKD is often accompanied by adverse outcomes owing to underlying comorbidities and/or risk factors including hypertension and renovascular disease (Khan et al., 2002).  In order to survive, ESRD patients require renal replacement therapy, dialysis or kidney transplantation, which significantly burden the patient and healthcare systems. More than 75% of the costs associated with CKD therapy are attributable to ESRD patients on hemodialysis, and yet ESRD patients initiating hemodialysis are expected to live only 4-5 years (Atala et al., 2006).  Hemodialysis is associated with multiple and serious complications and quality of life reductions such as arterio-venous graft infections, graft revision, and the need to undergo dialysis up to three times per week.  Kidney transplantation remains the most effective form of therapy; however, there is a chronic shortage of organs.  If a patient is able to secure a kidney for transplantation, the necessary immunosuppressive therapy that accompanies transplantation compromises the patient’s ability to combat infection and certain cancers.  Preventing or delaying adverse outcomes of CKD, including renal replacement therapy, by intervening early-on in the disease is the primary strategy in CKD management.  Nevertheless, early therapeutic approaches have been less than optimal.

When a patient reaches end-stage renal disease (ESRD), kidney replacement therapy (i.e. dialysis or kidney transplant) is indicated.  The vast majority of ESRD individuals receive hemodialysis (Dhingra et al., 2001).  Dialysis replaces about 5-15% of kidney function depending on the intensity and frequency of use, and helps restore fluid and electrolyte balance when kidneys fail.  However, the life-expectancy of an ESRD patient initiating hemodialysis is only 4-5 years (U S Renal Data System, 2012).

RegenMedTX is developing a cell-based product, Neo-Kidney Augment (NKA), designed to build renal function in patients with chronically diseased kidneys in order to delay renal replacement therapy (dialysis or kidney transplant).  RegenMedTX’s NKA is a percutaneous minimally invasive injectable product composed of the patient’s own selected renal cells (SRC).  The renal cells are obtained via a standard kidney biopsy procedure following standard medical biopsy practice. The SRC’s are isolated and expanded from the biopsy and formulated with a gelatin hydrogel making NKA.  NKA is then implanted into the patient’s diseased kidneys.  Access to the kidney may be obtained using standard minimally invasive percutaneous methods commonly used in hospitals and outpatient surgeries.

NKA implantation into the kidney is depicted below: (a) Cannula (needle) inserted into the kidney cortex, (b) NKA delivery, (c) Multiple deposition points in the kidney

 Illustration of NKA Delivery and Implantation

NKA Implantation cartoon

RegenMedTx is conducting a Phase 2 clinical trial for it’s Neo-Kidney Augment product. RegenMedTX Phase 2 clinical trial is based on  a successful Phase 1 clinical trial in in which 7 patients were implanted with NKA. Some of the first patients to be implanted  have now been followed for ~ 2 years and remain dialysis-free with stable renal function. .  The trial demonstrates that Neo-Kidney Augment is safe and well tolerated, stabilizing renal function for this period of time.

If you have medical questions, you should discuss them with your own doctor. We do not provide medical guidance beyond that of our Clinical trial center experts and medical monitor. More information on clinical trials is available at www.clinicaltrials.gov.

Additional information can be obtained from RegenMedTX at the ‘Contact Us’ page.

Clinical Trial News

FDA has approved a Phase II, Open-Label Safety and Efficacy Clinical Trial of RegenMedTX’s Autologous NEO-KIDNEY AUGMENT (NKA) in Patients with Type 2 Diabetes and Chronic Kidney Disease (CKD).