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Evaluation of the effect of autologous adipose derived stem cells stromal vascular fraction (SVF) on the treatment of generalized plaque psoriasis

Protocol summary

Study aim
Evaluation of the effect of autologous adipose derived stem cells stromal vascular fraction (SVF) on the treatment of generalized plaque psoriasis
Design
Before-after interventional clinical trial, without control group using availability sampling, performed on 5 patients with plaque psoriasis.
Settings and conduct
This study is performed on 5 patients with generalized plaque psoriasis referring to Ghaem and Imam Reza Hospitals of Mashhad who have Psoriasis Area and Severity Index (PASI) of more than 10 and have not used systemic drugs for psoriasis for any reasons within the last three months. Patients are selected using availability sampling and will be subjected to venous infusion of autologous SVF twice at intervals of one month. Then, patients will be examined during the first month after treatment, weekly for up to 1 month, and then monthly for up to 6 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Body Mass Index value of 18 to 25, Generalized plaque psoriasis based on Psoriasis Area and Severity Index (PASI) of more than 10 or based on more than 10% body involvement Exclusion criteria: coagulation disorder, heart, lung, kidney, liver diseases and malignancy, contraindication for liposuction, active infections including HIV, HCV, HBV, HTLV1, absence of mental health
Intervention groups
Intervention group: Patients are subjected to venous infusion of autologous adipose derived stem cells stromal vascular fraction (SVF) twice at intervals of one month. Each time, after an aspiration of 100 cc of adipose tissue, the achieved autologous SVF is injected intravenously into the patients' forearm area.The same procedure is repeated a month later.
Main outcome variables
Determination of Psoriasis Area and Severity Index (PASI); evaluation of inflammatory factors of interleukin 10 and 17; Interferon-Gamma; tumor necrosis factor; Dermatology Life Quality Index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150601022512N3
Registration date: 2019-03-09, 1397/12/18
Registration timing: prospective

Last update: 2019-03-09, 1397/12/18
Update count: 0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Masoud Maleki
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2510
Email address
malekim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of autologous adipose derived stem cells stromal vascular fraction (SVF) on the treatment of generalized plaque psoriasis
Public title
Evaluation of the effect of stromal vascular fraction (SVF) on the treatment of generalized plaque psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body Mass Index value of 18 to 25 generalized plaque psoriasis based on Psoriasis Area and Severity Index (PASI) of more than 10 or based on more than 10% body involvement
Exclusion criteria:
coagulation disorder use of anticoagulation medicines heart, lung, kidney, liver diseases and malignancy contraindication for liposuction active infections including HIV, HCV, HBV, HTLV1 absence of mental health
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-10-20, 1397/07/28
Ethics committee reference number
IR.MUMS.REC.1397.194

Health conditions studied

1

Description of health condition studied
Generalized plaque psoriasis
ICD-10 code
L40.0
ICD-10 code description
Psoriasis vulgaris

Primary outcomes

1

Description
Evaluation of interleukin serum level of 10
Timepoint
Before commencement of SVF injection and at 1, 3 and 6 months after the injection
Method of measurement
Venous blood sample

2

Description
Measurement of severity of psoriasis
Timepoint
Before and after treatment
Method of measurement
Psoriasis Area and Severity Index (PASI) questionnaire

3

Description
Quality-of-life Index of skin patients
Timepoint
Before and after treatment
Method of measurement
Dermatology Life Quality Index questionnaire

4

Description
Evaluation of interleukin serum level of 17
Timepoint
Before commencement of SVF injection and at 1, 3 and 6 months after the injection
Method of measurement
Venous blood sample

5

Description
Evaluation of tumor necrosis factor alpha
Timepoint
Before commencement of SVF injection and at 1, 3 and 6 months after the injection
Method of measurement
Laboratory method

6

Description
Evaluation of Interferon-Gamma serum level
Timepoint
Before commencement of SVF injection and at 1, 3 and 6 months after the injection
Method of measurement
Laboratory method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients are subjected to venous infusion of autologous adipose derived stem cells stromal vascular fraction (SVF) twice at intervals of one month. Each time, after an aspiration of 100 cc of adipose tissue and transfer to the the Academic Center for Education, Culture and Research, the achieved autologous SVF (0.5 to 20 million stem cells per 100 g) is injected intravenously into the patients' forearm area.The same procedure is repeated a month later. Then, patients will be examined during the first month after treatment, weekly for up to 1 month, and then monthly for up to 6 months.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology clinic, Imam Raza Hospital
Full name of responsible person
Masoud Maleki
Street address
Imam Reza Hospital, Imam Reza square, Ebn_e_sina Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2020
Email
malekim@mums.ac.ir

2

Recruitment center
Name of recruitment center
Dermatology clinic, Ghaem Hospital
Full name of responsible person
Faezeh Taghavi
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2493
Email
taghavif941@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Faezeh Taghavi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2493
Email
taghavif941@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Maleki
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Reza Hospital, Imam Reza Square, Ebn_e_Sina Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2020
Email
malekim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Faezeh Taghavi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2493
Email
taghavif941@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.
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