Mesenchymal Stromal CellsPhase 1/2NCT03392311
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis
A Phase 1/2 study testing Calcipotriol ointment 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.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment with moderate to severe psoriasis. Read more about this study
- 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 and adipose-derived multipotent mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2019to 19 Mar 2020
- Phase
- Phase 1/2
- 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
About this study
Official title: Efficacy and Safety of Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells Plus Calpocitriol Ointment 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 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.
- Conditions
- Mesenchymal Stromal Cells, Psoriasis, Drug Effect, Drug Toxicity
- Being tested
- Calcipotriol ointment, 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
The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
adipose-derived multipotent mesenchymal stem cellsBiological
Also called AD-MSCs
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| AD-MSCs plus Calcipotriol ointment group | Experimental | AD-MSCs（adipose-derived multipotent mesenchymal stem cells ） intravenous injection at a dose of 2 million cells/kg at week 0, week 2, week 4, week 6, week 8 with a duration for treatment for 12 weeks. The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks. Receives: Drug: Calcipotriol ointment; Biological: adipose-derived multipotent mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate of PASI(Psoriasis Area and Severity Index)
The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline
Measured: 12 weeks (plus or minus 3 days) after treatment
Secondary outcomes (7)
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
Relapse rate in treatment period / follow-up 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.
Measured: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
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.
- First posted5 Jan 2018
- Study start23 Jul 2019
- Primary completion23 Oct 2019
- Study completion19 Mar 2020
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Chuanjian Lu, PhD, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392311
- Sponsor's protocol ID
- S2016-04-02
- Status last verified
- Aug 2023
- First submitted
- 2 Jan 2018
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT03392311
- Acronym / sponsor ID
- S2016-04-02
- Conditions
- Mesenchymal Stromal Cells, Psoriasis, Drug Effect, Drug Toxicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 5 Jan 2018 (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.
The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD-MSCs plus Calcipotriol ointment group | Experimental | Drug: Calcipotriol ointment, Biological: adipose-derived multipotent mesenchymal stem cellsAD-MSCs（adipose-derived multipotent mesenchymal stem cells ） intravenous injection at a dose of 2 million cells/kg at week 0, week 2, week 4, week 6, week 8 with a duration for treatment for 12 weeks. The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) 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 ointmentThe topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks. | Drug | AD-MSCs plus Calcipotriol ointment group |
| adipose-derived multipotent mesenchymal stem cellsAlso: AD-MSCsAD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg. | Biological | AD-MSCs plus Calcipotriol ointment group |
Primary outcome
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
7 secondary outcomes
PASI(Psoriasis Area and Severity Index)
Time frame: 12 weeks (plus or minus 3 days) 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
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?
A Phase 1/2 study testing Calcipotriol ointment 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.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement rate of PASI(Psoriasis Area and Severity Index) (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?
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; AzTrials last refreshed its copy on 7 Nov 2026.