Safety and Effectiveness evaluation of Allogeneic Cord Blood Platelet Gel (CBPG) for the treatment of non-healing skin ulcers/erosion due to the cutaneous chronic GVHD: A Randomize Clinical Trial (Pilot study)
Finding early evidence of the safety and efficacy of using allogeneic cord blood platelet gel in the treatment of unhealed wounds in patients with chronic GvHD
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized, phase 1 is performed on 15 patients, enrolled between July 2020 and July 2021.
Settings and conduct
This randomized clinical trial is performed at the Pediatric Cell Therapy Research Center located in the Children Medical Center affiliated to the Tehran University of Medical Sciences. In the intervention area the platelet, gels are prescribed up to 6 times every 5 days for each patient and if after this number of treatments up to 50% improvement is not achieved, it is classified as non-respondent. Samples are taken from the corners of the wounds and tissue granulation is examined in a pathology laboratory. The surface of the wounds is imaged and its reduction is examined. All patients will be evaluated for wounds changes after 1, 3, and 6 months and follow-up continues until the end of 6 months after the intervention. Patients will be evaluated by direct observation of wounds, wound imaging, wound surface area, and depth and sampling to examine tissue granulation.
Participants/Inclusion and exclusion criteria
Existence of chronic GvHD criteria after allogeneic hematopoietic stem cell transplantation
Intervention groups
The control area will receive the usual treatment, which includes dressing and using Vaseline and mupirocin antibiotic ointment, and the intervention area will receive the platelet gel product. Gels are prescribed up to 6 times every 5 days for each patient.
Main outcome variables
It will involve wound healing, unchanging, and ultimately wound healing. Reducing the patient's pain is also considered as an initial consequence.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190101042197N1
Registration date:2020-08-24, 1399/06/03
Registration timing:registered_while_recruiting
Last update:2020-08-24, 1399/06/03
Update count:0
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Alireza Shoae-Hassani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 0031
Email address
alirezashoae@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and Effectiveness evaluation of Allogeneic Cord Blood Platelet Gel (CBPG) for the treatment of non-healing skin ulcers/erosion due to the cutaneous chronic GVHD: A Randomize Clinical Trial (Pilot study)
Public title
Application of Cord Blood Platelet Gel (CBPG) for the treatment of non-healing skin ulcers due to the cutaneous chronic GVHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of chronic GvHD criteria after allogeneic hematopoietic stem cell transplantation
Wounds in the upper, lower and trunk
Wound surface area more than 2 cm2 and less than 5 cm2 with at least 6 weeks durability
Wound grading is 2 and 3.
Minimum age one year and maximum 15 years
Exclusion criteria:
Other diseases such as diabetes, allergies, coagulopathies or underlying diseases that involve the skin
Wounds are small (less than 1 cm) or very large (more than 5 cm)
Wound grade is 1 or 4.
Lesions on the face and neck
Age
From 1 year old to 15 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Stratified Block Randomization method is used for randomization in the intervention and control groups. Since patients with different intensities are in the study, to ensure the equality of the number of people assigned to the two groups, the block randomization method is used in each category. Also, the blocks used are of sizes 2 and 4, and based on the sample size of 15 and the probable number of participants in the study with any severity of the disease, blocks with the appropriate volume are used to generate random codes. In order to place patients in control and intervention groups, a random sequence table is created with the SAS 9.1 software.
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
Ethics Committee in Research of Children's Medical Center-Tehran University of Medical Sciences
Street address
Childrens Medical Center, Gharib Ave, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Approval date
2020-07-11, 1399/04/21
Ethics committee reference number
IR.TUMS.CHMC.REC.1399.072
Health conditions studied
1
Description of health condition studied
Unhealed skin ulcers in patients with chronic GVHD skin complications
ICD-10 code
D89.811
ICD-10 code description
Chronic graft-versus-host disease
Primary outcomes
1
Description
Reduce wound surface area
Timepoint
At the beginning of the study and 7, 15 and 30 days after the start
Method of measurement
Direct view
2
Description
Causes severe allergic reactions
Timepoint
1, 3 and 7 days after the intervention
Method of measurement
Direct view
3
Description
Infection
Timepoint
One week after intervention
Method of measurement
Sampling
4
Description
Reduced pain
Timepoint
One month after intervention
Method of measurement
direct examination
Secondary outcomes
1
Description
Normal physical activity
Timepoint
6 month after intervention
Method of measurement
Direct examination and observation
Intervention groups
1
Description
Intervention group: Platelet gel from allogeneic cord blood. Cord blood is taken from the umbilical cord blood bank of Bon Yakhte Royan Co. and then in the clean room of the Pediatric Cell Therapy Research Center, platelet gel is prepared from it. The gels are administered up to 6 times every 5 days for each patient with chronic GvHD skin ulcer and are classified as non-responder if no improvement of up to 50% is achieved after this number of treatments. Samples are taken from the corners of the wounds and tissue granulation is examined in a pathology laboratory. The surface of the wounds is imaged and its reduction is examined.
Category
Treatment - Other
2
Description
Control group: The wounds of the control group will be dressed in sterile conditions using Vaseline gas after washing.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center Hospital
Full name of responsible person
Maryam Behfar
Street address
Children's Medical Center Hospital, Gharib Ave, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 8444
Email
behfar@alumnus.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Stem cell Technology Co.
Full name of responsible person
Morteza Zarrabi
Street address
No 24, East Hafez Alley, Bani Hashem Sq, Resalat Ave, Tehran
City
Tehran
Province
Tehran
Postal code
١٦٦٥٦٦٦٣١١
Phone
+98 21 2763 5000
Fax
+98 21 8978 1307
Email
crm@rsct.ir
Web page address
https://www.rsct.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Stem cell Technology Co.
Proportion provided by this source
60
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Rashin Mohseni
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Cell therapy
Street address
Gharib Ave, Keshavarz BLVD, Children's Medical Center
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 8444
Email
rashin_mohseni@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Amir Ali Hamidieh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Children's Medical Center, Gharib Ave, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 8444
Email
aahamidieh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Rashin Mohseni
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Cell therapy
Street address
Children's Medical Center, Gharib Ave, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 8444
Email
rashin_mohseni@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
Some data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of the access period one year after results publication.
To whom data/document is available
All
Under which criteria data/document could be used
There will be no limitation
From where data/document is obtainable
rashin_mohseni@yahoo.com
What processes are involved for a request to access data/document