Protocol summary
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Study aim
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Determining the Effectiveness and Investigating the Side Effects of Allogeneic transplantation of Adipose-derived Stem Cells on Skin Lesions of Patients with Psoriasis Plaque
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Design
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Two arms, parallel group, randomized, double blind, Phase I
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Settings and conduct
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This study is done on psoriasis patients referred to the Royan skin clinic. In the first phase, 2 groups of 3 patients are selected to recieve 1 and 3 million ASCs per cm2 of lesion, respectively. after 6 months follow-up, the best dose is chosen based on efficacy and safety outcomes.
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Participants/Inclusion and exclusion criteria
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Inclusion: patients older than 18 years of age, patients with chronic psoriasis plaque for at least 6 months, the Psoriasis Area Severity Index (PASI) index less than 12, plaque severity of moderate to severe (Grade 3 to 5), not response to standard treatments, absence of a new lesion, or an increase in the size of previous lesions in the last 6 months are included in the study. Exclusion: patients with other types of psoriasis including pustular, erythrodermic, gotate and drug induced, immunosuppressive drugs given in 4 weeks, and topical medications other than moisturizing lotions in the past 2 weeks, severe underlying disease (liver, kidney, and cardiac failure), Increased liver enzymes more than 3 times normal and creatinine more than 2, high and uncontrolled hypertension, pregnant or lactating, diabetes mellitus, patients with hepatitis B, C or HIV, immunocompromised patients, Malignancy, debilitating disease, and systemic infection or injection site are excluded.
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Intervention groups
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Allogeneic adipose-derived stromal cells in normal saline group
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Main outcome variables
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Side effects, severity of plaque psoriasis, PASI measures, inflammatory cytokines
General information
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Reason for update
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protocol amendment
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20080728001031N24
Registration date:
2018-05-30, 1397/03/09
Registration timing:
registered_while_recruiting
Last update:
2023-01-28, 1401/11/08
Update count:
1
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Registration date
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2018-05-30, 1397/03/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-04-04, 1396/01/15
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Expected recruitment end date
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2021-04-04, 1400/01/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Safety and efficacy of transplantation of adipose derived stem cells for skin lesions in patients with plaque psoriasis- phase I clinical trial
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Public title
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Safety and efficacy of cell therapy in psorisis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Chronic plaque psoriasis for at least 6 months
plaque severity of moderate to severe (grade 3-5)
Psoriasis Area Severity Index (PASI) less than 12
No response to standard treatments
No incidence of new lesion or increase in size of previous lesions during past 6 months
Exclusion criteria:
Other types of psoriasis include pustular, erythrodermic, gotate, and drug induced
Immunosuppressive drugs over the past 4 weeks or topical medications other than moisturizing lotions in the 2 past weeks
Severe underlying disease (including liver, kidney and heart failure), increased liver enzymes more than 3 times normal and creatinine more than 2
high and uncontrolled blood pressure
Pregnancy or lactation
diabetes mellitus
Hepatitis B, C or HIV
Patients with immunodeficiency
Patients with malignancy
Disabling disease
Systemic or injection site infection
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Age
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From 18 years old
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Gender
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Both
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Phase
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1
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
5
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: Simple
Randomization unit: Individual
stratified randomization is not included
Randomization Tool: Random number box
Allocation concealment: The cell products with different doses are delivered to the physician with code numbers. Then the dressings will be placed on the patient's lesion based on randomization number box.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, patients, researchers, health care persons including its physician and nurse, and the outcome evaluator are blinded until the end of study. For this purpose, the patient's lesions are divided into an intervention and control group based on the randomization table and the cell sample or placebo is sent to the physician with a code and the physician performs the injections according to the product label.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-04-15, 1394/01/26
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Ethics committee reference number
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1394.1.IR.ACECR.ROYAN.REC
Health conditions studied
1
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Description of health condition studied
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Psoriasis
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ICD-10 code
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L40
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ICD-10 code description
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Psoriasis
Primary outcomes
1
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Description
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Pain
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Timepoint
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intervention start date up to 6 months
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Method of measurement
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Pain intensity scale
2
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Description
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Redness severity
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Timepoint
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intervention start date up to 6 months
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Method of measurement
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Physical examination
Secondary outcomes
1
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Description
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Lesion severity (grade 0-5)
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Timepoint
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Before intervention, every week up to 1 month, and every month up to 6 months
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Method of measurement
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evaluator assessment
Intervention groups
1
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Description
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Intervention group 1: Single intra-dermal injection of 1 million adipose-derived stromal cells per cm2 of plaque (based on the results of Phase I study) into 0.5 ml of normal saline per cm2 of plaque and follow up to 6 months after injection. The cells are provided by Cell Tech Pharmed company.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Single intra-dermal injection of 3 million adipose-derived stromal cells per cm2 of plaque (based on the results of Phase I study) into 0.5 ml of normal saline per cm2 of plaque and follow up to 6 months after injection. The cells are provided by Cell Tech Pharmed company.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iranian academic center for education culture and research
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data will be shared after unidentifiable of the patients
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When the data will become available and for how long
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6 months after paper publication
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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In term of analysis the data related to study outcomes
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From where data/document is obtainable
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amir.bajouri@royaninstitute.org
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What processes are involved for a request to access data/document
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The request will be assessed by research committee of Royan Institute which will be taken around2 months
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Comments
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