Psoriasis Vulgaris Clinical Trial
Official title:
A Study to Assess Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cells (UC-MSCs) in Patients With Psoriasis Vulgaris
The purpose of this study is to investigate the safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with moderate to severe psoriasis vulgaris. Any adverse events related to UC-MSCs infusion will be monitored and the patients will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) in the baseline and after MSCs infusions.
Psoriasis is considered as an incurable immune-mediated inflammatory skin disease. The
widely used treatments include topical agents, systemic medications and biologic agents, but
all of them have some drawbacks or limitations. Besides, non-standardized treatment or the
disease itself may lead transformation to other diseases, which add more importance to
finding improved management strategies.
Mesenchymal stem cells (MSCs) are a heterogeneous population of cells that can differentiate
into bone, cartilage and fat cells. They have several functions, such as migration to skin
lesions, immunomodulation, limitation of autoimmunity and local paracrine effects. It
reported MSCs have already been used in some kinds of autoimmune disease, such as systemic
lupus erythematosus (SLE), systemic sclerosis, crohn disease, rheumatoid arthritis et al.
In this study, consenting umbilical cords are donated by healthy donors. After several
processing steps, UC-MSCs are separated and froze for future infusions. When volunteers are
recruited, their condition will be assessed by Psoriasis Activity and Severity Index (PASI)
and Dermatology Life Quality Index (DLQI). Then MSCs will be infused according to a standard
scheme. After all 6 infusions, the patient will be re-assessed by the PASI and DLQI and will
be followed up for one year.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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