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

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ClinicalTrials.gov Identifier: NCT04785027
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Traditional Chinese Medicine Drug Effect Drug Safety Psoriasis Mesenchymal Stromal Cells Drug: PSORI-CM01 formula Drug: Gu Ben Hua Yu formula Biological: adipose-derived multipotent mesenchymal stem cells Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 17, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
PSORI-CM01 group

Expanded Allogeneic Adipose-derived multipotent mesenchymal stem cells(AD-MSCs) will be administered by intravenous drip at a dose of 2×10 ^ 6 cells/kg at week 0, week 2, week 4, week 6, week 8 with a total of 5 times.

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

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
Other Name: Chinese Herbal Medicine

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
Other Names:
  • stem cells
  • AD-MSCs

Experimental: Gu Ben Hua Yu group

Expanded Allogeneic Adipose-derived multipotent mesenchymal stem cells(AD-MSCs) will be administered by intravenous drip at a dose of 2×10 ^ 6 cells/kg at week 0, week 2, week 4, week 6, week 8 with a total of 5 times.

Gu Ben Hua Yu 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
Other Name: Chinese Herbal Medicine

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
Other Names:
  • stem cells
  • AD-MSCs




Primary Outcome Measures :
  1. PASI score improvement rate [ Time Frame: 12 weeks (plus or minus 3 days) after treatment. ]
    PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100% PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72. The higher the score, the worse the disease.


Secondary Outcome Measures :
  1. 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. PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72. The higher the score, the worse the disease.

  2. Relapse rate in treatment period / follow-up period [ Time Frame: 12 weeks (plus or minus 3 days) after treatment. ]
    Relapse can be defined only for patients who achieve PASI-50,and occurs when the improvement in the PASI score falls below 50 percent from the baseline PASI score.

  3. PASI-50 [ Time Frame: 12 weeks (plus or minus 3 days) after treatment. ]
    The proportion of patients who achieve at least 50 percent improvement in PASI score from baseline.

  4. PASI-75 [ Time Frame: 12 weeks (plus or minus 3 days) after treatment. ]
    The proportion of patients who achieve at least 75 percent improvement in PASI score from baseline.

  5. Pruritus Scores on the Visual Analogue Scale [ Time Frame: 12 weeks (plus or minus 3 days) after treatment. ]
    Pruritus was assessed using the Visual Analogue Scales; The Scale scores ranged from 0-10. The higer the scores were, the more itching the patient suffered.

  6. BSA [ Time Frame: 12 weeks (plus or minus 3 days) after treatment. ]
    the Body Surface Area

  7. DLQI (Dermatology Life Quality Index) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment. ]
    the score of Dermatology Life Quality Index. Dermatology Life Quality Index (DLQI) is a self-administered 10-item questionnaire. It covers Symptoms and feelings, Daily activities, Leisure, Work and school, Personal relationships, and Treatment. The higher the score, the worse the quality of life.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.patients with psoriasis vulgaris(PASI > 7 or BSA >10%); 2.18 to 65 years old; 3.written/signed informed consent.

Exclusion Criteria:

  1. The skin lesions are seen alone on the patient's face, scalp, nails, wrinkles, glans, mucous membranes, palmar and plantar or guttate psoriasis;
  2. Acute progressive psoriasis, and erythroderma tendency;
  3. current (or within 1 year) pregnancy or lactation;
  4. current significant anxiety or depression with the Self-rating Anxiety Scale (SAS) > 50 or the Self-rating Depression Scale (SDS) > 53, or with other psychiatric disorders;
  5. With history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments. Those who with malignant diseases,infections, electrolyte imbalance, acid-base disturbance. Patients with clinical test results listed below: abnormal serum calcium level ( Ca2+> 2.9 mmol/L or < 2 mmol/L);AST or ALT 2 times more than normal upper limit; Creatinine and cystatin C more than normal upper limit;Hemoglobin elevates 20g/L more than normal upper limit,or hemoglobin reduction to anemia; Platelet count less than 75.0*10^9/L; White blood cell less than 3.0*10^9/L; Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study;
  6. Patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction;
  7. allergy to anything else ever before;
  8. current registration in other clinical trials or participation within a month;
  9. topical treatments (i.e. corticosteroids or retinoic acid or Vitamin D analogs ) within 2 weeks; systemic therapy or phototherapy (ultraviolet radiation B,UVB) and psoralen combined with ultraviolet A (PUVA) within 4 weeks; biological therapy within 12 weeks;
  10. medical conditions assessed by investigators, that are not suitable for this clinical study.

Information from the National Library of Medicine

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): NCT04785027


Contacts
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Contact: Chuanjian Lu, PhD +8620-81887233-31223 luchuanjian888@vip.sina.com
Contact: Danni Yao, PhD +8620-81887233-35934 yaodanni1984@163.com

Locations
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China, Guangdong
Guangdong Provincial Hospital of Traditional Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Chuanjian Lu, PhD    +8620-81887233-31223    luchuanjian888@vip.sina.com   
Contact: Zehuai Wen, PhD    #86#13903008091    wenzehuai@139.com   
Sub-Investigator: Danni Yao         
Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
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Principal Investigator: Chuanjian Lu, PhD Guangdong Provincial Hospital of Traditional Chinese Medicine
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Responsible Party: Chuanjian Lu, Professor, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT04785027    
Other Study ID Numbers: S2020-01-01
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine:
Traditional Chinese Medicine
Mesenchymal Stem Cells
Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases