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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Adults (≥18 years) with nephropathy of any degree (microalbuminuria, overt proteinuria, CKD stages 1-5 not on dialysis, or post-transplant with proteinuria). Stable background therapy with ACEi/ARB, SGLT2i, or MRA allowed.

Locations
Other Locations
Egypt
British Centre For Regenerative medicine BCRMED Global
RECRUITING
Giza
Contact Information
Primary
Dr. Alaa Abdelkarim M Fouad, MRCPUK SEC
dralaa@ace-cells.co.uk
+447473922553
Backup
Dr. Shireen S Amer, MD
shireenamer@gmail.com
+20102 3340300
Time Frame
Start Date: 2025-09-20
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 300
Treatments
Experimental: 1 ml sublingual 4 times daily for 12 weeks
Participants will receive ACE Reno, a standardized oral transmucosal solution containing low-molecular-weight bioactive peptides and amino acids.~The formulation is designed to engage antifibrotic (BMP-7-like, HGF-like, Klotho-like) and vasodilatory/natriuretic peptide-like pathways relevant to glomerular and tubulointerstitial function.~No genetic material is present; formulation is peptide-based only.
Sponsors
Leads: Ace Cells Lab Limited

This content was sourced from clinicaltrials.gov