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

NCT07187713 | Recruiting Phase 4

• 1 other identifier: ACE_Reno
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertensive Nephropathy; Auto Immune Disorders; Chronic Kidney Disease; Chronc Kidney Disease Stage 5; Chronic Kidney Disease (Stage 3-4); Chronic Kidney Disease (Stages 4 and 5); Microalbuminuria; Diabetic Nephropathies

Keywords

chronic kidney disease; ckd; nephropathy

Outcome Measures

Primary Outcomes (1)

• Change in Urinary Albumin-to-Creatinine Ratio (ACR)

  Percent change in log-transformed urinary ACR measured from first-morning urine samples. The primary analysis compares baseline to Week 12 values

  12 weeks

Secondary Outcomes (9)

• Change in Estimated Glomerular Filtration Rate (eGFR) slope

  Baseline, Week 4, Week 8, Week 12

• Change in 24-hour Proteinuria

  Baseline to Week 12 (subset of participants with baseline nephrotic-range proteinuria)

• Change in Blood Pressure

  Baseline, Week 4, Week 8, Week 12

• Safety and Tolerability

  Throughout treatment and up to Week 16 follow-up

• Safety and Tolerability

  Throughout treatment and up to Week 16 follow-up

Other Outcomes (1)

• Hospitalization Events

  Baseline to Week 16

Study Arms (1)

1 ml sublingual 4 times daily for 12 weeks

EXPERIMENTAL

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.

Drug: ACE Reno

Interventions

ACE Reno DRUG

1 ml sublingual 4 times daily for 12 weeks

1 ml sublingual 4 times daily for 12 weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Recent kidney transplant (\<12 months). Uncontrolled acute infection or unstable autoimmune disease. Pregnancy or lactation. Known hypersensitivity to study components.

Sponsors & Collaborators

• Ace Cells Lab Limited: lead

Study Sites (1)

British Centre For Regenerative medicine BCRMED Global

Giza, GZ, 12311, Egypt

RECRUITING

MeSH Terms

Conditions

Hypertensive Nephropathy; Renal Insufficiency, Chronic; Diabetic Nephropathies; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Prof. Dr. Mohammed Yasser Sayyed Saif, PhD

  Beni Suef Univeristy

  PRINCIPAL INVESTIGATOR

• Dr. Alaa Abdelkarim M Fouad, MRCPUK SEC

  British Centre for Regenerative medicine BCRMED

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Alaa Abdelkarim M Fouad, MRCPUK SEC

CONTACT

+447473922553; dralaa@ace-cells.co.uk

Dr. Shireen S Amer, MD

CONTACT

+20102 3340300; shireenamer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1 ml sublingually 4 times a day for 12 weeks

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 23, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)