Investigation of the effect of a bandage containing stem cells derived from human-paired tissue on chronic wound healing in diabetic patients
Design
This is a phase 2 clinical trial intervention study. Regardless of gender, individuals between the ages of 18 and 45 will be selected. A sample size of 30 individuals has been considered and will be randomly assigned to the designated groups. Entry criteria: Informed consent for the treatment of grade 1 or 2 wounds with a diagnosis of diabetes and no pregnancy. Exit criteria: patients with uncontrolled disease history, pregnant individuals, and individuals with cancerous or pre-cancerous lesions in the treated area.
Settings and conduct
On the day of transplantation, an appropriate number of AAM, AMM+PLMSC, and PLMSC will be transferred to the clinic. During the transplantation, continuous monitoring of vital signs (heart rate, oxygen saturation, heart rhythm, and blood pressure) and any undesirable signs will be performed.
Participants/Inclusion and exclusion criteria
Informed consent for the treatment of grade 1 or 2 wounds with a diagnosis of diabetes and no pregnancy. Exit criteria: patients with uncontrolled disease history, pregnant individuals, and individuals with cancerous or pre-cancerous lesions in the treated area.
Investigating the effect of a scaffold containing human placenta-derived mesenchymal stem cells in diabetic chronic wounds healing (phase II)
Public title
stem cells for diabetic chronic wounds healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sign Informed consent form
Diagnosed with diabetes mellitus
no pregnancy
grade 1 or 2 wounds
Men or women, 18 years old and above
Exclusion criteria:
uncontrolled disease history
pregnancy
cancerous or pre-cancerous lesions in the treated area
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
This study will use a randomized, double-blind design to investigate the effect of AAM and PLMSCs on wound healing in diabetic patients. Participants will be randomly assigned to one of three groups: AAM group, PLMSCs + AAM group, or control group. The AAM group will receive a scaffold containing an acellular amniotic membrane, the PLMSCs + AAM group will receive a scaffold containing both placenta-derived mesenchymal stem cells and acellular amniotic membrane, and the control group will receive a placebo scaffold without any active ingredients.
Randomization will be performed using a computer-generated randomization list that will be created by an independent statistician. The randomization list will be stratified by age, gender, and wound size to ensure a balance between the three groups. The study investigators, participants, and outcome assessors will be blinded to treatment allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
To maintain blinding, all study scaffolds will be identical in appearance and packaging. The study investigators will not know which scaffold each participant receives. The outcome assessors will also be blinded to treatment allocation and will not know which group each participant belongs to when assessing wound healing outcomes.
In addition, participants will be instructed not to reveal their treatment allocation to the outcome assessors during follow-up visits. Any unblinding events will be recorded and reported in the study findings.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Endocrine & Metabolism Research Institute Ethics Committee
Street address
No.111,19th st., North Kargar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14579-65597
Approval date
2023-04-15, 1402/01/26
Ethics committee reference number
IR.TUMS.EMRI.REC.1402.010
Health conditions studied
1
Description of health condition studied
diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Percentage of wound closure
Timepoint
several weeks to several months
Method of measurement
It will be measured using digital photography and software analysis
Secondary outcomes
1
Description
time to complete wound closure
Timepoint
vary from weeks to months
Method of measurement
digital photography and software analysis
2
Description
pain reduction
Timepoint
several weeks
Method of measurement
visual analog scale
3
Description
quality of life improvement
Timepoint
several months to several years
Method of measurement
validated questionnaire
Intervention groups
1
Description
Intervention group 1: AAM (Acellular amniotic membrane) Amniotic membrane preparation: The acellular amniotic membrane were used to providing the three-dimensional scaffold for seeding MSCs. After obtaining informed consent placenta was donated from healthy mother after caesarean delivery. placenta rinsed in sterile (PBS) and then human amniotic membrane(HAM) was separated from the chorion with forceps and washed three times with PBScontaining Penicillin-Streptomycin (10,000 U/mL)( gibco, usa) and cut into 3 cm×3 cm pieces, which were placed in dishes with the amniotic epithelial layer face up. Then pieces of HAM were decellularized with 0.5 M NaOH according to previous study(Saghizadeh, Winkler et al. 2013). all the procedures were carried out under aseptic conditions. haematoxylin and eosin (H&E) staining of the samples were accomplished to confirme Aecellularization process. Samples were viewed by light microscopy after staining with H&E. On the desired day for transplantation, membranes and tissue engineering products are transported to the hospital by Cool Box, and in this group, the acellularized amnion membrane is placed on the wound site. After 6 weeks, the final result will be seen. Of course, during this period, the healing process of the wound will be checked once a week.
Category
Treatment - Devices
2
Description
Intervention group 2: AAM+PLMSCs (acellular human amniotic membrane graft+placenta-derived MSCs). Mesenchymal stem cells are counted and suspended in fresh culture media. In each piece, 3 ml of cell suspension is planted and incubated at 37°C, 5% CO2 and 95% humidity. After 24 hours, the culture medium is changed. On the fifth day, the prepared tissue engineered grafts will be ready for transplantation. The grafts are packed in sterile bottles and transported to the clinic for transplantation. Grafts are transplanted to the wound site for 6 weeks, this transplant will be done once a week, and after 6 weeks the results will be evaluated. Patients will be followed up weekly for the first month and then monthly for 6 months.
Category
Treatment - Devices
3
Description
Control group: Ctrl (will receive a normal dressing)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic
Full name of responsible person
Dr. Ensieh Nasli-Esfahani
Street address
No.111, 19th st., North Kargar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14579-65597
Phone
+98 21 8835 4367
Email
barjmand@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Neda Mehrdad
Street address
No.111,19th st., North Kargar Ave., Tehran, Iran
City
tehran
Province
Tehran
Postal code
14579-65597
Phone
+98 21 8835 4367
Email
barjmand@sina.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
50
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Babak Arjmand
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Internal Medicine
Street address
No 111, 19th St., North Kargar Ave., Tehran 14114, Iran, 1457965597, Tel +98 218 835 4367
City
tehran
Province
Tehran
Postal code
1457965597
Phone
+98 21 8835 4367
Fax
Email
barjmand@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Babak Arjmand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Internal Medicine
Street address
No 111, 19th St., North Kargar Ave., Tehran 14114, Iran, 1457965597, Tel +98 218 835 4367
City
tehran
Province
Tehran
Postal code
1457965597
Phone
+98 21 8835 4367
Fax
Email
barjmand@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Babak Arjmand
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Internal Medicine
Street address
No 111, 19th St., North Kargar Ave., Tehran 14114, Iran, 1457965597, Tel +98 218 835 4367
City
tehran
Province
Tehran
Postal code
1457965597
Phone
+98 21 8835 4367
Fax
Email
barjmand@sina.tums.ac.ir
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