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

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03265613 on ClinicalTrials.gov