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Safety and efficacy of injection of adipose tissue derived mesanchymal exosomes for skin lesions in patients with chronic plaque psoriasis

Protocol summary

Study aim
Determination of the Safety and efficacy of injection of adipose tissue-derived mesenchymal exosomes for skin lesions in patients with chronic plaque psoriasis
Design
parallel group, 12 patient, Phase I ,clinical trial
Settings and conduct
This study is performed on psoriasis patients. In the first phase of this study, 3 groups of 4 patients were selected. For these groups, 50, 100 and 200 micrograms per milliliter per square centimeter of skin lesion are injected, respectively. Also a lesion at the injection site with the same sensitivity and severity as the control. At a 3-month follow-up, the best dose is selected for best efficacy and minimal side effects.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 12 patients over 18 years, 6 months of history, PASI index 3 to10, low to moderate lesion severity (1 to 3), non-response to standard treatment, no lesion, or increase in the last 6 months. Exclusion Criteria: Other types of disease including pustular, erythrodermic, Use of immunosuppressive drugs in the past 2 weeks and topical drugs except for emollients in the past 2 weeks Severe underlying disease, increase in liver enzymes more than 3 times normal and creatinine more than 2, high and uncontrolled hypertension, pregnant or lactating women, Patients with diabetes, patients with hepatitis B, C or HIV, immunocompromised patients, malignant patients, debilitating disease, systemic infection or injection site
Intervention groups
Group 1 includes patients with psoriasis who receive a stem cell-derived exosome at a dose of 50 micrograms. Group 2 includes patients with psoriasis who receive a stem cell-derived exosome at a dose of 100 micrograms. Group 3 includes patients with psoriasis who receive a stem cell-derived exosome at a dose of 200 micrograms.
Main outcome variables
Side effects, severity of plaque, PASI measures, inflammatory cytokines

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080901001159N29
Registration date: 2020-10-05, 1399/07/14
Registration timing: registered_while_recruiting

Last update: 2020-10-05, 1399/07/14
Update count: 0
Registration date
2020-10-05, 1399/07/14
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2021-01-04, 1399/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of injection of adipose tissue derived mesanchymal exosomes for skin lesions in patients with chronic plaque psoriasis
Public title
Safety and efficacy of cell therapy in psorisis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic plaque psoriasis for at least 6 months plaque Mild to severity of moderate (grade 1-3) PASI 3-12 No response to standard treatments No incidence of new lesion or increase in size of previous lesions during past 3 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
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University Of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۹۴۳۴۷۱
Approval date
2020-06-17, 1399/03/28
Ethics committee reference number
IR.TUMS.VCR.REC.1399.523

Health conditions studied

1

Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis

Primary outcomes

1

Description
Pain
Timepoint
intervention start date up to 3 months
Method of measurement
Pain intensity scale

2

Description
Redness severity
Timepoint
intervention start date up to 3 months
Method of measurement
Physical examination

Secondary outcomes

1

Description
Lesion severity (grade 1-3)
Timepoint
Before intervention, every week up to 1 month, and every month up to 3 months
Method of measurement
evaluator assessment

Intervention groups

1

Description
Intervention First group: Single intra-dermal injection of 50 μg of exosomes derived from adipose tissue mesenchymal cells per cm2 of plaque into 0.5 ml of normal saline and follow up to 3 months after injection. Also, in the same area of ​​the lesion where the injection is performed, a lesion with the same sensitivity and severity is considered as a control. The Cells cultured in a cleanroom at the Skin and Stem Cell Research Center, Tehran University of Medical Sciences and, the exosomes are isolated using an ultracentrifuge
Category
Treatment - Drugs

2

Description
Intervention second group: Single intra-dermal injection of 100 μg of exosomes derived from adipose tissue mesenchymal cells per cm2 of plaque into 0.5 ml of normal saline and follow up to 3 months after injection. Also, in the same area of ​​the lesion where the injection is performed, a lesion with the same sensitivity and severity is considered as a control. The Cells cultured in a cleanroom at the Skin and Stem Cell Research Center, Tehran University of Medical Sciences and, the exosomes are isolated using an ultracentrifuge
Category
Treatment - Drugs

3

Description
Intervention Third group: Single intra-dermal injection of 200 μg of exosomes derived from adipose tissue mesenchymal cells per cm2 of plaque into 0.5 ml of normal saline and follow up to 3 months after injection. Also, in the same area of ​​the lesion where the injection is performed, a lesion with the same sensitivity and severity is considered as a control. The Cells cultured in a cleanroom at the Skin and Stem Cell Research Center, Tehran University of Medical Sciences and, the exosomes are isolated using an ultracentrifuge
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4. Maryam Alley. South Kamranyeh Street, Skin and Stem Cell Research Center , Tehran University of Medical Sciences,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19379-57511
Phone
+98 21 2221 5558
Email
Afsaneh.najafi@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
4No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2251 5558
Fax
+98 21 2665 7438
Email
tmarkaz@yahoo.com
Web page address
http://skinstemcell.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Full name of responsible person
Mohamad Ali Mohseni Meybodi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, Southern Kamraniyeh, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 5158
Fax
+98 21 2223 9264
Email
alimohseni6154@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Skin and Stem Cell Research Center, third floor, no 4, Maryam impasse, Kamranieh st, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2223 9387
Fax
Email
nilforoosh@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Skin and Stem Cell Research Center of Tehran University of Medical sciences
Full name of responsible person
Mona Mahmoudbeyk
Position
Research manager
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
mmahmoodbeyk@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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