Psoriasis. Psoriasis
Conditions
Interventions
Intervention 1: The first intervention group: under treatment with local injection of exosome (derived from cord blood serum purchased from Apsa company) with a concentration of 50 micrograms per mill
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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%
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEhsan Taghiabadi
Tehran University of Medical Sciences
Outcome results
None listed