Mesenchymal Stromal CellsNCT04275024

Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients

A study testing Calcipotriol ointment, PSORI-CM01 Granule and adipose-derived multipotent mesenchymal stem cells in people with Mesenchymal Stromal Cells and Psoriasis, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Mesenchymal Stromal Cells, Psoriasis, Drug Effect
What is being tested?: Calcipotriol ointment, PSORI-CM01 Granule and adipose-derived multipotent mesenchymal stem cells
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteChina
Study dates: 1 Apr 2020to 3 Feb 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

moderate to severe psoriasis vulgaris ( PASI > 10 or BSA >10%)
18 to 65 years old
written/signed informed consent

Who cannot join

guttate psoriasis, inverse psoriasis or exclusively associated with the face
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

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong

Other trials in China

About this study

Official title: Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Patients With Moderate to Severe Psoriasis

The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment and PSORI-CM01 Granule with moderate to severe psoriasis. Any adverse events related to AD-MSCs infusion will be monitored.The primary outcome is the reduction rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after treatment.

Read the detailed description

Conditions: Mesenchymal Stromal Cells, Psoriasis, Drug Effect, Drug Toxicity
Being tested: Calcipotriol ointment, PSORI-CM01 Granule, adipose-derived multipotent mesenchymal stem cells
Medical subject headings: Psoriasis, Drug-Related Side Effects and Adverse Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Calcipotriol ointmentDrug
Also called Dovonex
The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
PSORI-CM01 GranuleDrug
Also called Chinese Herbal Medicine
PSORI-CM01#YXBCM01# granule 5.5g os once a day for 12weeks.
adipose-derived multipotent mesenchymal stem cellsBiological
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg

Study groups in NCT04275024
Study group	Role	What they receive
Experimental group	Experimental	AD-MSCs: adipose-derived multipotent mesenchymal stem cells intravenous injection at a dose of 2 million cells/kg of body weight at week 0, week 2, week 4, week 6, week 8 with a duration for treatment for 12 weeks. The basic treatment is oral PSORI-CM01 Granule plus calcipotriol ointment (Dovonex;LEO Laboratories Ltd, Ireland) for topical use twice daily for 12 weeks. Receives: Drug: Calcipotriol ointment; Drug: PSORI-CM01 Granule; Biological: adipose-derived multipotent mesenchymal stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

PASI score improvement rate
PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%
Measured: 12 weeks (plus or minus 3 days) after treatment

Secondary outcomes (6)

PASI(Psoriasis Area and Severity Index)
The improvement in PASI score from baseline after treatment
Measured: 12 weeks (plus or minus 3 days) after treatment
PASI-50
The proportion of patients who achieve at least 50% improvement in PASI score from baseline
Measured: 12 weeks (plus or minus 3 days) after treatment
PASI-75
The proportion of patients who achieve at least 75% improvement in PASI score from baseline
Measured: 12 weeks (plus or minus 3 days) after treatment
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
Measured: 12 weeks (plus or minus 3 days) after treatment
BSA
the Body Surface Area
Measured: 12 weeks (plus or minus 3 days) after treatment
DLQI(Dermatology Life Quality Index)
the Dermatology Life Quality Index
Measured: 12 weeks (plus or minus 3 days) after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20203 Feb 2021

First posted19 Feb 2020
Study start1 Apr 2020
Primary completion17 Jun 2020
Study completion3 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mesenchymal Stromal CellsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04275024
Sponsor's protocol ID: S2016-05-02
Status last verified: Aug 2023
First submitted: 16 Feb 2020
Last updated: 24 Aug 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mesenchymal Stromal Cells trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Patients With Moderate to Severe Psoriasis
ClinicalTrials.gov ID: NCT04275024
Acronym / sponsor ID: S2016-05-02
Conditions: Mesenchymal Stromal Cells, Psoriasis, Drug Effect, Drug Toxicity
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
Study start: 1 Apr 2020 (actual)
Primary completion: 17 Jun 2020 (actual)
Study completion: 3 Feb 2021 (actual)
First posted: 19 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental group	Experimental	Drug: Calcipotriol ointment, Drug: PSORI-CM01 Granule, Biological: adipose-derived multipotent mesenchymal stem cellsAD-MSCs: adipose-derived multipotent mesenchymal stem cells intravenous injection at a dose of 2 million cells/kg of body weight at week 0, week 2, week 4, week 6, week 8 with a duration for treatment for 12 weeks. The basic treatment is oral PSORI-CM01 Granule plus calcipotriol ointment (Dovonex;LEO Laboratories Ltd, Ireland) for topical use twice daily for 12 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

moderate to severe psoriasis vulgaris ( PASI > 10 or BSA >10%)
18 to 65 years old
written/signed informed consent

Key exclusion criteria (10 listed)

guttate psoriasis, inverse psoriasis or exclusively associated with the face
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Calcipotriol ointmentAlso: DovonexThe topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.	Drug	Experimental group
PSORI-CM01 GranuleAlso: Chinese Herbal MedicinePSORI-CM01#YXBCM01# granule 5.5g os once a day for 12weeks.	Drug	Experimental group
adipose-derived multipotent mesenchymal stem cellsAD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg	Biological	Experimental group

Primary outcome

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%

6 secondary outcomes

PASI(Psoriasis Area and Severity Index)
Time frame: 12 weeks (plus or minus 3 days) after treatment
PASI-50
Time frame: 12 weeks (plus or minus 3 days) after treatment
PASI-75
Time frame: 12 weeks (plus or minus 3 days) after treatment
Pruritus Scores on the Visual Analogue Scale
Time frame: 12 weeks (plus or minus 3 days) after treatment
BSA
Time frame: 12 weeks (plus or minus 3 days) after treatment
DLQI(Dermatology Life Quality Index)
Time frame: 12 weeks (plus or minus 3 days) after treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chuanjian Lu, PhD principal investigator

Guangdong Provincial Hospital of Traditional Chinese Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PASI score improvement rate (time frame: 12 weeks (plus or minus 3 days) after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04275024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.