Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis
NCT03265613 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2023-08-25
Summary
The purpose of this study is to evaluate the safety and efficacy of Adipose-derived Mesenchymal Stem Cells (AD-MSCs) with moderate to severe psoriasis. Any adverse events related to AD-MSCs infusion will be monitored. Safety is assessed using incidence of Adverse Events(AEs) and Serious Adverse Events (SAEs). Efficacy is assessed via the proportion of the improvement of PASI (Psoriasis Area and Severity Index), relapse rate in treatment period, changes in PASI score and BSA, as well as DLQI.
Conditions
- Mesenchymal Stromal Cells
- Psoriasis
- Drug Toxicity
- Drug Effect
Interventions
- BIOLOGICAL
-
adipose-derived multipotent mesenchymal stem cells
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 0.5 million cells/kg.
Sponsors & Collaborators
-
Guangdong Provincial Hospital of Traditional Chinese Medicine
lead OTHER
Principal Investigators
-
Chuanjian Lu · Guangdong Provincial Hospital of Traditional Chinese Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-24
- Primary Completion
- 2019-08-20
- Completion
- 2019-11-28
Countries
- China
Study Locations
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