1. Home
  2. Approved trials
  3. » فارسی

Safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for healing of deep second-degree burn wounds: clinical trial phase II

Protocol summary

Study aim
Determining the safety and efficacy of allogeneic cultured keratinocyte sheets in the treatment of acute second-degree burns
Design
In this parallel 3 group, open-label clinical trial study that will be started after the completion of phase I clinical trial follow-ups, 35 patients will be enrolled in regular order according to standard protocols. Based on the randomization list, three separate wounds of a single patient will be selected and allogeneic keratinocyte sheet transplantation (as intervention), autologous skin transplantation, or conventional treatment will be selected for each wound.
Settings and conduct
Location: Operating room of Shahid Motahari Hospital in Tehran Preliminary laboratory tests are performed at Royan Research Institute and clinical and paraclinical tests are performed at Shahid Motahari Hospital.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 70 years with deep second-degree heat burns involving 20 to 50% of the body surface, if they express written consent to participate in the study and wish to attend regular treatment and follow-up courses, enter the study. Pregnant or breastfeeding patients, with uncontrolled underlying disease, requiring intensive care, or multiple traumas are not included in the study.
Intervention groups
Product type: Allogeneic keratinocyte sheet How to use: Allogeneic keratinocyte sheet transplant size 60cm2 Number of transplantation: 1 or 2 times
Main outcome variables
Evaluation of side effects, including short-term and long-term, systemic or local, severe or mild, and related and unrelated side effects of cell therapy at times 3, 7, 10, 14, 21, 28 days, and 3 and 6 months after intervention according to CTCAEV5 criteria

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080728001031N36
Registration date: 2024-03-15, 1402/12/25
Registration timing: prospective

Last update: 2024-03-15, 1402/12/25
Update count: 0
Registration date
2024-03-15, 1402/12/25
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-06-20, 1404/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for healing of deep second-degree burn wounds: clinical trial phase II
Public title
Safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for healing of deep second-degree burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-70 years Acute second-degree heat burns involving 20-50% of the body surface Existence of at least three deep second-degree burn wound with 60 cm2 in area in the trunk or limbs (except the joints and arms & feet) in which tendons, blood vessels, or bone tissue is not exposed Declaration of written consent to participate in the study and willingness to attend regular treatment and follow-up course
Exclusion criteria:
Chronic uncontrolled underlying disease (vascular disease, diabetes, malnutrition, hypertension, cardiovascular disease) Known underlying psychiatric illness Pregnancy or breastfeeding History of cancer or chemotherapy Infection with viral diseases (HCV, HBV, HIV) History of organ transplantation or blood transfusion History of taking immunosuppressive or cytotoxic drugs during the last 6 months Respiratory injury Requires special care Multiple trauma (fracture, or thoracic, abdominal, or CNS trauma)
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 35
More than 1 sample in each individual
Number of samples in each individual: 3
Based on the randomization list, three separate wounds of a single patient will be selected and allogeneic keratinocyte sheet transplantation, autologous skin transplantation, or conventional treatment will be selected for each wound.
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software will be used as the method for randomization. By means of random allocation, each patient's wounds will be assigned to one of the three groups: Group A (autograft), Group B (conventional treatment), or Group C (Keratinocyte sheet). This allocation will follow a 1:1:1 ratio and will adhere to a computer-generated randomization schedule that considers specific strata based on the wound site.
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
Research ethics committees of Royan institute-Academic center for education, culture and research
Street address
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Ghasem Soleymani Highway
City
Tehran
Province
Tehran
Postal code
1951883831
Approval date
2022-03-08, 1400/12/17
Ethics committee reference number
IR.ACECR.ROYAN.REC.1400.165

Health conditions studied

1

Description of health condition studied
Acute second-degree burn wound on the upper limbs
ICD-10 code
T22.2
ICD-10 code description
Burn of second degree of shoulder and upper limb, except wrist and hand

2

Description of health condition studied
Acute second degree burn wound in trunk
ICD-10 code
T21.2
ICD-10 code description
Burn of second degree of trunk

3

Description of health condition studied
Acute second-degree burn wound on the lower limbs
ICD-10 code
T24.2
ICD-10 code description
Burn of second degree of lower limb, except ankle and foot

4

Description of health condition studied
Acute second degree burn wound involving 25-40% of body surface
ICD-10 code
T31.2
ICD-10 code description
Burns involving 20-29% of body surface

5

Description of health condition studied
Acute second degree burn wound involving 25-40% of body surface
ICD-10 code
T31.3
ICD-10 code description
Burns involving 30-39% of body surface

Primary outcomes

1

Description
No observed short-term or long-term, systemic or local, severe or mild, and related or unrelated to cell therapy adverse effects
Timepoint
before the intervention, 3, 7, 10, 14, 21, 28 days, 3, and 6 months after the intervention
Method of measurement
CTCAEV5 methods

Secondary outcomes

1

Description
Duration of wound epithelialization
Timepoint
3, 7, 10, 14, 21, 28 days after intervention
Method of measurement
Solar calendar

2

Description
Graft take rate
Timepoint
3, 7, 10, 14, 21, 28 days after intervention
Method of measurement
Physician evaluation

3

Description
Scar assessment
Timepoint
3 and 6 months after the intervention
Method of measurement
Based on Patient and Observer Scar Assessment Scale (POSAS) score

4

Description
scar assessment
Timepoint
3 and 6 months after the intervention
Method of measurement
Based on (VSS) Vancouver scar scale score

5

Description
Wound closure and scar shape
Timepoint
3, 7, 10, 14, 21, 28 days and 3 and 6 months after the intervention
Method of measurement
Based on 2D photography by Canon powershot S5Is

Intervention groups

1

Description
Intervention group: One of the three deep second-degree burn wound of 60 cm2 in limbs or trunk (except joints, arms, legs, and areas where tendons, blood vessels, or bone tissue are exposed) will be selected randomly. This area will be transplanted with an allogeneic keratinocyte sheet with an area of 60 square centimeters. If the wound does not heal on the tenth day, the transplant will be repeated.
Category
Treatment - Other

2

Description
Control group: One of the three deep second-degree burn wound of 60 cm2 in limbs or trunk (except joints, arms, legs, and areas where tendons, blood vessels, or bone tissue are exposed) will be selected randomly. This area will be treated with Vaseline dressing and topical antibiotic as conventional treatment.
Category
Treatment - Other

3

Description
Intervention group: One of the three deep second-degree burn wound of 60 cm2 in limbs or trunk (except joints, arms, legs, and areas where tendons, blood vessels, or bone tissue are exposed) will be selected randomly. This area will be transplanted with an Autologous skin graft with an area of 60 square centimeters as standard treatment.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Ensiyeh Hajizadeh Saffar
Street address
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Resalat Highway
City
Tehran
Province
Tehran
Postal code
1665664511
Phone
+98 21 2233 9942
Email
hajizadeh.ehs@gmail.com

2

Recruitment center
Name of recruitment center
Shahid Motahari hospital
Full name of responsible person
Mostafa Dahmardehei
Street address
Shahid Motahari Hospital, Shahid Yasemi St, Vanak, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8877 0031
Email
m.dahmardei@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
ATI tech pharmed
Full name of responsible person
Mostafa Najarasl
Street address
Golbarg alley. Royan alley. E Hafez St. Bani Hashem St. Resalat Highway
City
Tehran
Province
Tehran
Postal code
1663915563
Phone
+98 21 2356 2506
Email
mostafanajar@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ATI tech pharmed
Proportion provided by this source
100
Public or private sector
Private
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
Royan Institute
Full name of responsible person
Shayan Farzanbakhsh
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Resalat Highway
City
Tehran
Province
Tehran
Postal code
1665664511
Phone
+98 21 2251 8388
Email
Shayan.farzanb@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Ensiyeh Hajizadeh Saffar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Resalat Highway
City
Tehran
Province
Tehran
Postal code
1665664511
Phone
+98 21 2233 9942
Email
hajizadeh.ehs@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Hoda Madani
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Resalat Highway
City
Tehran
Province
Tehran
Postal code
1665664511
Phone
+98 21 2251 8388
Email
hoda62_m@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
Loading...