Trials / Completed
CompletedNCT04275024
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Patients With Moderate to Severe Psoriasis
- Status
- Completed
- Phase
- N/A
- 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 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.
Detailed description
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
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. |
| 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 |
Timeline
- Start date
- 2020-04-01
- Primary completion
- 2020-06-17
- Completion
- 2021-02-03
- First posted
- 2020-02-19
- Last updated
- 2023-08-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04275024. Inclusion in this directory is not an endorsement.