Protocol summary

Study aim
Investigating the safety and efficacy of intradermal stromal vascular fraction (SVF) cells injection of autologous fat tissue in patients with scleroderma (clinical, biometric and laboratory evaluation) (Phase I and II clinical study)
Design
Clinical trial with one control and one intervention grous, with parallel groups, single blind, non random assignment to intervention and control groups, phase I- II، 18 patients with scleroderma
Settings and conduct
The intervention site is the Skin and Stem Cell Research Center of Tehran University of Medical Sciences. In the intervention group, patients are treated with SVF injection, and in the control group, patients are only treated with Nanofet alone. In this study, the person evaluating the outcome will be considered blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient is suffering from scleroderma and has been diagnosed by a doctor, the patient has skin involvement in the fingers or face, the patient is in the stable phase of the disease, which is confirmed by the attending physician the patient has the desire to perform the mentioned procedure. Non-inclusion criterion: suffering from infectious diseases.
Intervention groups
Intervention group: patients will receive a single injection of 5 cc of SVF cells (20 million cells). Control group: patients will be injected once with 5 cc of nanofat.
Main outcome variables
Qualitative intensity of scleroderma, Quantitative intensity of scleroderma

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200127046282N35
Registration date: 2024-05-25, 1403/03/05
Registration timing: prospective

Last update: 2024-05-25, 1403/03/05
Update count: 0
Registration date
2024-05-25, 1403/03/05
Registrant information
Name
Sona Zare
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7438
Email address
sonazarebio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-04, 1403/03/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the safety and efficacy of intradermal stromal vascular fraction cells injection of autologous fat tissue in patients with scleroderma (clinical, biometric and laboratory evaluation): Phase I and II clinical study
Public title
Investigating the safety and efficacy of injection of fat tissue cells in patients with scleroderma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is suffering from scleroderma and has been diagnosed by a doctor. The patient has skin involvement in the fingers or face. The patient is in the stable phase of the disease, which is confirmed by the attending physician. The patient has the desire to perform the mentioned procedure.
Exclusion criteria:
having infectious diseases.
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 18
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The photos and biometric data of the participants will be reviewed by a medical staff who has no information about this study and the allocation of groups. Therefore, the study will be single blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of School of Medicine-Tehran University of Medical Sciences
Street address
Room 604, 6th Floor, Tehran University of Medical Sciences Central Building, Qods St. intersection, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.046

Health conditions studied

1

Description of health condition studied
scleroderma
ICD-10 code
M34
ICD-10 code description
Systemic sclerosis [scleroderma]

Primary outcomes

1

Description
Qualitative intensity of scleroderma
Timepoint
Before treatment and 3 months after treatment
Method of measurement
Patient complaint, objective evaluation by a physician

Secondary outcomes

1

Description
Quantitative intensity of scleroderma
Timepoint
Before treatment, three months after treatmen
Method of measurement
Determine the size of the lesions with visioface, determine the location and number of lesions

2

Description
The rate of improvement of scleroderma
Timepoint
Before treatment, three months after treatment
Method of measurement
Patient satisfaction, visioface photography, physician diagnosis

3

Description
Adverse events
Timepoint
Before treatment, three months after treatment
Method of measurement
Patient report, Physician diagnosis

Intervention groups

1

Description
Intervention group: Patients will undergo a single injection of 5 cc of SVF cells (20 million cells) at the lesion site.
Category
Treatment - Other

2

Description
Control group: Patients will undergo a single injection of 5 cc of nanofat (20 million cells) at the lesion site.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Skin and Stem cell Research Center Clinic, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
nilforoosh@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Vice Chancellor for Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 6381 9836
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
nilforoosh@sina.tums.ac.ir

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
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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