ACE Reno Pico Cell Matrix for reducing proteinuria and supporting kidney function
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
This trial will test whether taking ACE Reno, a sublingual peptide solution four times daily for 12 weeks, can lower urine protein and help stabilize kidney function in adults with nephropathy or chronic kidney disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ace Cells Lab Limited Industry-sponsored |
| Locations | 1 site (Giza, GZ) |
| Trial ID | NCT07187713 on ClinicalTrials.gov |
What this trial studies
This is an open-label, single-arm study giving ACE Reno (1 mL sublingually four times daily) for 12 weeks with a 4-week safety follow-up. The main measure is change in urinary albumin-to-creatinine ratio (ACR) at 12 weeks, with secondary measures including eGFR slope, proteinuria, blood pressure, and patient-reported outcomes. The trial enrolls adults with nephropathy across a range of causes and CKD stages (including post-transplant proteinuria) while allowing stable background therapies such as ACEi/ARB and SGLT2i. Exploratory biomarker analyses (e.g., TGF-β, NGAL, KIM-1, cGMP) and durability of response up to 6 months in responders will also be collected.
Who should consider this trial
Good fit: Adults (≥18) with nephropathy or chronic kidney disease stages 1–5 not on dialysis, or post-transplant patients with proteinuria, who are willing to take a sublingual medication and attend scheduled visits are ideal candidates.
Not a fit: People on maintenance dialysis, those with a kidney transplant within the past 12 months, active uncontrolled infections or unstable autoimmune disease, pregnant or breastfeeding persons, or anyone with known hypersensitivity to the product are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, ACE Reno could reduce albuminuria and slow kidney function decline, potentially delaying progression to advanced CKD or dialysis.
How similar studies have performed: This peptide-based, multi-domain sublingual approach is largely novel in clinical practice; there is some preclinical and early-phase supportive data for anti-fibrotic peptides but limited clinical evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Recent kidney transplant (\<12 months). Uncontrolled acute infection or unstable autoimmune disease. Pregnancy or lactation. Known hypersensitivity to study components.
Where this trial is running
Giza, GZ
- British Centre For Regenerative medicine BCRMED Global — Giza, Gz, Egypt (Recruiting)
Study contacts
- Principal investigator: Prof. Dr. Mohammed Yasser Sayyed Saif, PhD — Beni Suef Univeristy
- Study coordinator: Dr. Alaa Abdelkarim M Fouad, MRCPUK SEC
- Email: dralaa@ace-cells.co.uk
- Phone: +447473922553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.