Psoriasis. Psoriasis
Conditions
Interventions
Intervention 1: Intervention group 1: Single intra-dermal injection of 1 million adipose-derived stromal cells per cm2 of plaque (based on the results of Phase I study) into 0.5 ml of normal saline pe
Sponsors
Iranian academic center for education culture and research
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Chronic plaque psoriasis for at least 6 months plaque severity of moderate to severe (grade 3-5) Psoriasis Area Severity Index (PASI) less than 12 No response to standard treatments No incidence of new lesion or increase in size of previous lesions during past 6 months
Exclusion criteria
Exclusion criteria: Other types of psoriasis include pustular, erythrodermic, gotate, and drug induced Immunosuppressive drugs over the past 4 weeks or topical medications other than moisturizing lotions in the 2 past weeks Severe underlying disease (including liver, kidney and heart failure), increased liver enzymes more than 3 times normal and creatinine more than 2 high and uncontrolled blood pressure Pregnancy or lactation diabetes mellitus Hepatitis B, C or HIV Patients with immunodeficiency Patients with malignancy Disabling disease Systemic or injection site infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain. Timepoint: intervention start date up to 6 months. Method of measurement: Pain intensity scale.;Redness severity. Timepoint: intervention start date up to 6 months. Method of measurement: Physical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Lesion severity (grade 0-5). Timepoint: Before intervention, every week up to 1 month, and every month up to 6 months. Method of measurement: evaluator assessment. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmir Bajouri
Iranian academic center for education culture and research
Outcome results
None listed