Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients

NCT04275024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-08-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment and PSORI-CM01 Granule 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

DRUG

Calcipotriol ointment

The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.

DRUG

PSORI-CM01 Granule

PSORI-CM01#YXBCM01# granule 5.5g os once a day for 12weeks.

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

Sponsors & Collaborators

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Chuanjian Lu, PhD · 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
2020-04-01
Primary Completion
2020-06-17
Completion
2021-02-03

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 NCT04275024 on ClinicalTrials.gov