AION Healthspan Kicks Off First-in-Human Trial for REJUVXL: A Novel Cell Therapy for Chronic Kidney Disease

AION Healthspan, Inc., a clinical-stage biotech focused on regenerative medicine for both acute and chronic degenerative diseases, has announced the launch of enrollment for its first-in-human Phase I/II clinical trial. The trial, which targets Diabetic Nephropathy and other forms of Chronic Kidney Disease (CKD, Stage 3), has received clearance from the U.S. Food and Drug Administration (FDA) to proceed under its Investigational New Drug (IND) application for REJUVXL, the company’s proprietary cell therapy. REJUVXL, targets inflammation, fibrosis, immunity, and aging at the cellular level. While its first clinical focus is on CKD, AION Healthspan plans to expand into additional indications.

REJUVXL Targets Inflammation, Fibrosis, and Immune Dysregulation to Promote Tissue Regeneration in CKD

The Phase I/II study (NCT06721143) is being conducted at the University of Miami Health System to evaluate the safety, tolerability, and early signs of effectiveness of REJUVXL in patients with CKD. If proven successful, this therapy could potentially slow or even reverse CKD progression, potentially preventing the need for dialysis, kidney transplants, or the development of end-stage renal disease (ESRD).

REJUVXL works by addressing the underlying pathophysiological factors of CKD, including chronic inflammation, fibrosis (renal scarring), and immune system dysregulation. It aims to promote tissue regeneration, angiogenesis (the formation of new blood vessels), and modulate the immune response. These mechanisms have the potential to slow or even halt disease progression at earlier stages of CKD, where current therapies primarily focus on symptom management and slowing progression, without directly repairing renal damage.

Dr. Yelena Drexler, Principal Investigator on the CKD trial, stated: “If successful, REJUVXL has the potential to transform the landscape of chronic kidney disease treatment. CKD represents a significant and growing health challenge, and despite advances in care, current therapies are limited in their ability to halt or reverse disease progression. The objective of REJUVXL is to target the underlying causes of CKD—chronic inflammation and fibrosis—while promoting tissue repair and regeneration. If successful, this therapy has the potential to change the course of the disease for millions of patients, reducing the need for dialysis and transplant, and ultimately improving patient outcomes and quality of life.”

CKD Affects 1 in 3 Diabetics and 38% of Seniors, Impacting 110 Million in the U.S. and Europe

CKD impacts one in three adults with diabetes (Diabetic Kidney Disease) and 38% of individuals over 65, affecting over 110 million people across the U.S. and Europe. Although current treatments, such as blood pressure management, dietary changes, and medications like ACE inhibitors or SGLT2 inhibitors, can slow progression, they don’t halt or reverse the underlying disease. As CKD worsens, kidney function declines, leading to the need for more invasive treatments. Early intervention is key, especially in CKD Stage 3, where therapies could have the most impact on preserving kidney function and improving quality of life.

“At a time when the compound annual growth rate for kidney diseases has reached that of cancer, REJUVXL is uniquely positioned toward a successful clinical development,” says Alessia Fornoni, MD PhD, nephrologist and member of the Scientific Advisory Board of AION Healthspan. REJUVXL aims to address this unmet need by improving kidney function and offering potential benefits for patients at earlier stages of CKD.

REJUVXL is a cell therapy derived from perinatal tissues, typically discarded after healthy births. The therapy uses a manufacturing process that produces large batches of doses, administered via a simple IV infusion, similar to a blood transfusion. Unlike current CKD treatments, REJUVXL doesn’t require immunosuppressive drugs to prevent cell rejection. 

What sets REJUVXL apart is its use of cells obtained after birth, avoiding the ethical and medical concerns of embryonic or fetal cells. Current CKD treatments, such as blood pressure control and diabetes management, focus on managing symptoms and slowing disease progression but don’t address the underlying causes of CKD.

CKD Treatment Landscape: Current Drugs 

The market for CKD treatments relies on key drug classes, including diuretics, ACE inhibitors, ARBs (angiotensin II receptor blockers), calcium channel blockers (CCBs), mineralocorticoid receptor antagonists (MRAs), and Kerendia (finerenone). These drugs help manage CKD symptoms, control blood pressure, reduce proteinuria, and prevent further kidney damage. Diuretics reduce fluid retention, ACE inhibitors and ARBs control hypertension and protein leakage, while MRAs address the underlying fibrosis contributing to kidney decline. Finerenone, a newer addition, shows promise in improving outcomes in CKD patients, particularly those with type 2 diabetes.

AION Healthspan develops REJUVXL as a new approach to treating CKD, focusing on the underlying causes of inflammation, fibrosis, and immune dysregulation. CKD affects millions globally, and current therapies primarily manage symptoms without reversing disease progression. Ongoing clinical trials and research will provide further insight into how REJUVXL impacts CKD management and patient outcomes.

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Author

Bernice Lottering