NCT03392311

Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis

Efficacy and Safety of Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment with moderate to severe psoriasis. Any adverse events related to AD-MSCs infusion will be monitored.The primary outcome is the reduction rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after treatment.

Conditions

• Mesenchymal Stromal Cells
• Psoriasis
• Drug Effect
• Drug Toxicity

Interventions

Type	Name	Description
DRUG	Calcipotriol ointment	The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
BIOLOGICAL	adipose-derived multipotent mesenchymal stem cells	AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg.

Timeline

• Start date: 2019-07-23
• Primary completion: 2019-10-23
• Completion: 2020-03-19
• First posted: 2018-01-05
• Last updated: 2023-08-24

Locations

1 site across 1 country: China