Safety, Tolerability and Efficacy of GcMAF in Patients With Chronic Inflammatory Diseases

Launched by S.LAB (SOLOWAYS) · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called GcMAF for people with chronic inflammatory diseases, such as moderate rheumatoid arthritis or chronic cystitis, who haven't found relief with standard therapies. GcMAF is a protein designed to help boost the body’s immune response by activating certain immune cells that fight inflammation. The trial is divided into two phases: the first phase will focus on testing the safety of GcMAF and finding the best dose, while the second phase will further evaluate how effective it is compared to a placebo (a treatment that looks real but doesn’t contain the active drug) in a larger group of patients.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of a chronic inflammatory disease. They should also have experienced insufficient relief or side effects from standard anti-inflammatory medications. However, pregnant or breastfeeding individuals, those with serious health issues, or active severe infections cannot participate. The trial is currently not recruiting, but once it starts, participants can expect close monitoring and support throughout the study to ensure their safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Inclusion criteria
• • Age ≥ 18 years, informed consent.
• • Confirmed diagnosis of a chronic inflammatory disease (e.g., moderate rheumatoid arthritis or chronic cystitis, or another validated nosology) according to recognized criteria.
• • Insufficient effect or intolerance of standard anti-inflammatory therapy (NSAIDs, GCS, etc.).
• • Ability to comply with the study protocol.
• Exclusion Criteria:
• • Pregnancy, lactation (lack of safety data in this group).
• • Severe systemic diseases (liver/renal failure, severe cardiovascular diseases, uncontrolled arterial hypertension).
• • Active serious infections (HIV, tuberculosis, hepatitis B/C in the active phase).
• • Previous participation in other experimental studies \< 3 months ago.
• • Severe allergy to protein components of the drug.