Ace Cells Lab Limited

Summary of the Study This clinical trial evaluates a novel peptide-based therapy for treating retinal dystrophies, age-related macular degeneration (AMD), and diabetic retinopathy (DR). The therapy consists of peptides derived from fetal tissues, mesenchymal stem cells (MSCs), and bioactive growth factors, administered sublingually for systemic absorption.
Study Objectives:
Primary Objectives: Assess safety and tolerability, and evaluate the therapy's effects on retinal function and structure.
Secondary Objectives: Explore improvements in visual acuity, retinal thickness, vascular health, and disease biomarkers.
Study Design:
Type: Open-label, single-arm interventional study. Duration: 12 months.
Participants: 150 adults, divided into three cohorts:
Retinal dystrophies. AMD (dry and wet forms). DR (moderate NPDR and PDR).
Intervention:
A sublingual solution containing peptides and growth factors, taken 4 times daily.
Outcome Measures:
Primary Outcomes: Safety (adverse events) and tolerability (treatment adherence).
Secondary Outcomes:
Functional: Visual acuity and field sensitivity improvements. Structural: Retinal thickness and vascular health. Biomarkers: Serum VEGF, oxidative stress, and inflammatory markers.
Study Procedures:
Monthly follow-ups for safety monitoring, vision tests, retinal imaging (OCT, FA), and blood biomarker analysis.
Comprehensive evaluations at baseline, 6 months, and 12 months. Significance: The study aims to provide an innovative, non-invasive treatment for debilitating retinal conditions, potentially improving vision and retinal health through systemic therapy.

Chronic skin disease lead to skin damage and disfiguring to the patient skin. Sometimes, achieving normal skin is not possible by the normal traditional treatment, this study is focusing on use of ACE CSD formula which is mixture of natural peptides and herbs. the main aim is to restore the normal skin appearance for the patient and control the episodes of flare.