Efficacy and Safety of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis (ADMSP)
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|ClinicalTrials.gov Identifier: NCT03265613|
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : May 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mesenchymal Stromal Cells Psoriasis Drug Effect Drug Toxicity||Biological: adipose-derived multipotent mesenchymal stem cells||Phase 1 Phase 2|
Psoriasis is an immune-mediated, genetic disease manifesting in the skin or joints or both. Numerous topical and systemic therapies are available for the treatment of psoriasis. 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.
Mesenchymal stem cells (MSCs) are a kind of adult stem cells that can differentiate into bone, cartilage and adipose cells. Adipos-derived Mesenchymal Stem Cells(AD-MSCs) were isolated from fat tissues and were reported to treat moderate to severe psoriasis vulgaris and psoriasis arthritis successfully by case reports. For the mechanism of the disease, involvement of the immune system in psoriasis is now widely accepted. Mesenchymal stem cells (MSCs) are found to have the function of immunomodulation, migration to skin lesions, limitation of autoimmunity. Therefore, investigators supposed that the injection of AD-MSCs could be beneficial for treatment of moderate to severe psoriasis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells in Patients With Moderate to Severe Psoriasis|
|Actual Study Start Date :||September 24, 2017|
|Estimated Primary Completion Date :||July 20, 2019|
|Estimated Study Completion Date :||December 28, 2019|
Experimental: AD-MSCs group
AD-MSCs（adipose-derived multipotent mesenchymal stem cells ） intravenous injection at a dose of 0.5 million cells/kg at week 0,week 4，week 8 with a duration for treatment for 12 weeks.
Biological: adipose-derived multipotent mesenchymal stem cells
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 0.5 million cells/kg.
Other Name: AD-MSCs
- Improvement rate of PASI(Psoriasis Area and Severity Index) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline
- PASI(Psoriasis Area and Severity Index) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]The improvement in PASI score from baseline after treatment
- Relapse rate in treatment period / follow-up period [ Time Frame: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period ]Relapse can be defined only for patients who achieve PASI50，and occurs when the improvement in the PASI score falls below 50% from the baseline PASI score.
- PASI-50 [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]The proportion of patients who achieve at least 50% improvement in PASI score from baseline.
- PASI-75 [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]The proportion of patients who achieve at least 75% improvement in PASI score from baseline.
- Pruritus Scores on the Visual Analogue Scale [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]Pruritus Scores on the Visual Analogue Scale
- BSA [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]the Body Surface Area
- DLQI（Dermatology Life Quality Index） [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]the Dermatology Life Quality Index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265613
|Contact: Chuanjian Lu, PhDfirstname.lastname@example.org|
|Contact: Danni Yao, PhDemail@example.com|
|Guangdong Provincial Hospital of Traditional Chinese Medicine||Recruiting|
|Guangzhou, Guangdong, China|
|Contact: Chuanjian Lu, Doctor (8620)81887233 ext 31223 firstname.lastname@example.org|
|Contact: Zehuai Wen, Doctor （86）13903008091 email@example.com|
|Principal Investigator: Chuanjian Lu, Doctor|
|Sub-Investigator: Danni Yao|
|Principal Investigator:||Chuanjian Lu||Guangdong Provincial Hospital of Traditional Chinese Medicine|