Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04785027
Status:
RECRUITING
Last Update Posted:
2023-08-24
First Post:
2021-02-28
Brief Title:
Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With AD-MSCs in Psoriasis
Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Organization:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study Overview
Official Title:
Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells in Patients With Moderate to Severe Psoriasis a Pilot Study for a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Psoriasis is an immune-mediated genetic disease manifesting in the skin or joints or both Treatment modalities are chosen on the basis of disease severity relevant comorbidities patient preference For moderate to severe psoriasis phototherapy systemic therapy and biologic immune modifying agents are recommended but all of them have some drawbacks or limitations Until now no curative treatment is available Therefore it is important to find new treatment for psoriasis
As current experience and cases of AD-MSCs in the treatment of psoriasis are still relatively small and it is unknown about their safety and efficacy combined with traditional medicine in the treatment of psoriasis
This study designed a randomized controlled trial to compare PSORI-CM01 formula vs Guben Huayu formula combined with expanded allogeneic adipose-derived mesenchymal stem cells in the treatment of psoriasis 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 also aims to determine the feasibility and the potential of the protocol for the full-scale randomized controlled trial RCT
Therefore 16 subjects will be enrolled in this study and their expectations for the treatment of traditional Chinese medicine combined with stem cells and their experience to participate in this study will be interviewed
As current experience and cases of AD-MSCs in the treatment of psoriasis are still relatively small and it is unknown about their safety and efficacy combined with traditional medicine in the treatment of psoriasis
This study designed a randomized controlled trial to compare PSORI-CM01 formula vs Guben Huayu formula combined with expanded allogeneic adipose-derived mesenchymal stem cells in the treatment of psoriasis 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 also aims to determine the feasibility and the potential of the protocol for the full-scale randomized controlled trial RCT
Therefore 16 subjects will be enrolled in this study and their expectations for the treatment of traditional Chinese medicine combined with stem cells and their experience to participate in this study will be interviewed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None