Safety and efficacy of injection of Umbilical Cord Blood Serum derived exosomes for skin lesions in patients with chronic psoriasis
- Conditions
- Psoriasis.Psoriasis
- Registration Number
- IRCT20221130056672N4
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Age older than 18 years
Patients with chronic plaque psoriasis for at least 6 months
PASI index 3 to 12
Lesion intensity 1 to 3 (rating 0 to 5)
Lack of proper response to standard treatments including local treatments, light therapy and systemic treatments
Not creating new lesions or increasing the size of previous lesions in the last 3 months
Skin lesion with BSA higher than 10%
Use of systemic immunosuppressive drugs in the last 4 weeks and topical drugs except emollients in the last 2 weeks
Severe underlying disease (liver-kidney and heart failure)
Increase of liver enzymes > 3 times normal and creatinine > 2
Patients with diabetes mellitus, patients with a history of hepatitis B, C or HIV
Pregnant and nursing mothers
Patients with immunodeficiency, patients with malignancy, presence of debilitating disease, presence of active infection
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PASI index:Psoriasis Area Severity Index (PASI). Timepoint: The measurement will be at the beginning of the study (before the start of the intervention) and 7, 14, 21, 30 and 60 days after the first injection. Method of measurement: analysis and impact of data using biometric like High-Frequency Sonography.
- Secondary Outcome Measures
Name Time Method Safety. Timepoint: At the beginning of the intervention, in each re-visit session and one month after the end of the treatment period (four months after the start of the treatment). Method of measurement: Patient history.