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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.

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

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

Other trials in China

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.

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 groups in NCT03392311
Study groupRoleWhat they receive
AD-MSCs plus Calcipotriol ointment groupExperimentalAD-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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. BSA

    the Body Surface Area

    Measured: 12 weeks (plus or minus 3 days) after treatment

  7. 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. First posted5 Jan 2018
  2. Study start23 Jul 2019
  3. Primary completion23 Oct 2019
  4. Study completion19 Mar 2020

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT03392311.

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.

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