NCT04785027

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

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: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• 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 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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-17
• Primary completion: 2021-06-17
• Completion: 2024-09-30
• First posted: 2021-03-05
• Last updated: 2023-08-24

Locations

1 site across 1 country: China