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
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