RecruitingPhase 4NCT07187713

ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases

ACE Reno, Effect of Pico Cell Matrix on Patients With Micro-albuminuria, Proteinuria or CKD (of Any Degree) Due to Diabetes Mellitus, Autoimmune, Miscellaneous Aetiology


Sponsor

Ace Cells Lab Limited

Enrollment

300 participants

Start Date

Sep 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study investigates the safety and efficacy of ACE Reno, an oral transmucosal solution containing standardized bioactive peptides and amino acids, in patients with nephropathy of various etiologies and stages. The trial evaluates whether 12 weeks of ACE Reno (1 mL sublingually four times daily) reduces albuminuria/proteinuria and stabilizes kidney function in participants with nephropathy due to diabetes, hypertension, autoimmune disease, reflux/UTI, chronic glomerulonephritis, unknown etiology, pre-dialysis CKD, or post-transplant proteinuria. Nephropathy remains a global health burden, with \~9-10% of the population affected by chronic kidney disease (CKD), equating to \>750 million individuals worldwide. The socioeconomic costs are substantial: in England CKD costs \~£7 billion annually, projected to rise to \~£14 billion by 2033; in Malaysia, prevalence rose from 9% to 15.5% within 7 years; in Egypt, CKD imposes heavy familial and financial burdens, especially for pediatric patients; in Turkey, CKD is among the top causes of disability, linked to the rising tide of diabetes, obesity, and hypertension. ACE Reno is designed to address multiple drivers of CKD progression - glomerulosclerosis, fibrosis, endothelial dysfunction, and maladaptive RAAS/aldosterone signaling - through its peptide components that mimic antifibrotic (BMP-7, HGF, Klotho-like) and vasodilatory/cGMP-mediated (natriuretic peptide-like) pathways.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the ACE Reno Pico Cell Matrix, an investigational treatment, to see whether it can slow or improve kidney function decline (as measured by eGFR, a key marker of kidney health) in people with chronic kidney disease (CKD) of any cause. **You may be eligible if...** - You are 18 or older with any degree of kidney damage, including early protein leakage in urine, CKD stages 1–5 (not yet on dialysis), or post-transplant with proteinuria - You may already be taking standard kidney-protective medications (ACE inhibitors, ARBs, SGLT2 inhibitors, or similar) **You may NOT be eligible if...** - You had a kidney transplant in the past 12 months - You have an uncontrolled active infection or unstable autoimmune disease - You are pregnant or breastfeeding - You have a known allergy to the study components Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGACE Reno

1 ml sublingual 4 times daily for 12 weeks


Locations(1)

British Centre For Regenerative medicine BCRMED Global

Giza, GZ, Egypt

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NCT07187713


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