Status:
COMPLETED
Safety, Tolerability and Efficacy of GcMAF in Patients With Chronic Inflammatory Diseases
Lead Sponsor:
S.LAB (SOLOWAYS)
Collaborating Sponsors:
Center for New Medical Technologies, Novosibirsk, Russia
Conditions:
Inflammation
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study, titled "A Multicenter Phase I/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of GcMAF in Patients With Chronic Inflammatory Diseases" will investigate Gc Macrophage A...
Detailed Description
This trial is designed to evaluate GcMAF, an immunomodulatory protein generated from vitamin D-binding protein (DBP) via specific enzymatic deglycosylation, in adults (≥18 years) with a confirmed chro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06877364
Start Date
September 1 2025
End Date
November 3 2025
Last Update
December 16 2025
Active Locations (1)
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1
Center For New Medical Technologies
Novosibirsk, Russia