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

Primary Purpose

Traditional Chinese Medicine, Drug Effect, Drug Safety

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

PSORI-CM01 formula

Gu Ben Hua Yu formula

adipose-derived multipotent mesenchymal stem cells

About this trial

This is an interventional treatment trial for Traditional Chinese Medicine focused on measuring Traditional Chinese Medicine, Mesenchymal Stem Cells, Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

The skin lesions are seen alone on the patient's face, scalp, nails, wrinkles, glans, mucous membranes, palmar and plantar or guttate psoriasis;
Acute progressive psoriasis, and erythroderma tendency;
current (or within 1 year) pregnancy or lactation;
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;
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;
Patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction;
allergy to anything else ever before;
current registration in other clinical trials or participation within a month;
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;
medical conditions assessed by investigators, that are not suitable for this clinical study.

Sites / Locations

Guangdong Provincial Hospital of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

PSORI-CM01 group

Gu Ben Hua Yu group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PASI score improvement rate

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

PASI (Psoriasis Area and Severity Index)

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.

Relapse rate in treatment period / follow-up period

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.

PASI-50

The proportion of patients who achieve at least 50 percent improvement in PASI score from baseline.

PASI-75

The proportion of patients who achieve at least 75 percent improvement in PASI score from baseline.

Pruritus Scores on the Visual Analogue Scale

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.

BSA

the Body Surface Area

DLQI (Dermatology Life Quality Index)

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.

Full Information

NCT ID

NCT04785027

First Posted

February 28, 2021

Last Updated

August 23, 2023

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04785027

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 17, 2021 (Actual)

Primary Completion Date

June 17, 2021 (Actual)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Traditional Chinese Medicine, Mesenchymal Stem Cells, Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PSORI-CM01 group

Arm Type

Other

Arm Description

Arm Title

Gu Ben Hua Yu group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

PSORI-CM01 formula

Other Intervention Name(s)

Chinese Herbal Medicine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gu Ben Hua Yu formula

Other Intervention Name(s)

Chinese Herbal Medicine

Intervention Description

Gu Ben Hua Yu formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs

Intervention Type

Biological

Intervention Name(s)

adipose-derived multipotent mesenchymal stem cells

Other Intervention Name(s)

stem cells, AD-MSCs

Intervention Description

AD-MSCs (adipose-derived multipotent mesenchymal stem cells) will be infused intravenously at a dose of 2 million cells/kg

Primary Outcome Measure Information:

Title

PASI score improvement rate

Description

Time Frame