MedTrace Logo

Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With AD-MSCs in Psoriasis

NCT04785027 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-08-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate and compare the safety and efficacy of PSORI-CM01 formula vs Gu Ben Hua Yu formula combined with Expanded Allogeneic AD-MSCs in patients with moderate to severe psoriasis. And it explores the expectations of patients for the treatment of traditional Chinese medicine combined with stem cells and their expectations to participate in this study. The trial would provide preliminary data for large sample clinical randomized controlled trials.

Conditions

  • Traditional Chinese Medicine
  • Drug Effect
  • Drug Safety
  • Psoriasis
  • Mesenchymal Stromal Cells

Interventions

DRUG

PSORI-CM01 formula

PSORI-CM01 formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs

DRUG

Gu Ben Hua Yu formula

Gu Ben Hua Yu formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs

BIOLOGICAL

adipose-derived multipotent mesenchymal stem cells

AD-MSCs (adipose-derived multipotent mesenchymal stem cells) will be 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
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-17
Primary Completion
2021-06-17
Completion
2024-09-30

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 NCT04785027 on ClinicalTrials.gov