Evaluation of Safety and Effectiveness of Expanded Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer (Phase I/II Clinical Trail)
Evaluation of Safety and Effectivness of Expanded Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer
Design
In this study, 20 volunteers with Wagner Grade 2 diabetic foot ulcer will be recruited. This study will be a phase I and II clinical trial that the patients after standard treatment (debridement, infection control and off-loading) will be undergone adipose drived mesenchymal stem cell injection. The investigators will follow the patients for weekly up to first months, biweekly up to third months and monthly up to six months. The outcomes will be local and systemic reactions, wound area changes, and frequency of complete healing during study period.
Settings and conduct
This study will be conducted at Wound Healing Center of ACECR as a Phase I and II clinical trial in the volunteers with neuropatic diabetic foot wound.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: volunteers with chronic neuropathic diabetic foot ulcer (more than 6 weeks) with wound classification Wagner II, Suitable tissue perfusion (ABI>0.8) and full informed consent for recruitment in the study. Exclusion Criteria: Suspected osteomyelitis, using corticosteroid or immuno-suppressor drug, chronic renal failure of hemodialysis, and charco Joint.
Intervention groups
Intervention group is the injection of adipose drived mesenchymal stem cells in one session.
Main outcome variables
1) Local and systemic side effects
2) complete healing rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170612034485N2
Registration date:2018-02-11, 1396/11/22
Registration timing:registered_while_recruiting
Last update:2018-02-11, 1396/11/22
Update count:1
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Gholamreza Esmaeeli Djavid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6698 9110
Email address
djavid@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Safety and Effectiveness of Expanded Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer (Phase I/II Clinical Trail)
Public title
Allogenic stem cell in diabetic wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic neuropathic diabetic foot ulcer (more than 6 weeks) with wound classification Wagner II
full informed consent for recruitment in the study
Suitable tissue perfusion (ABI>0.8) and normal flow of main arteries in lower extremities
Exclusion criteria:
Suspected osteomyelitis
Using corticosteroid or immuno-suppressor drug
Chronic renal failure of Hemodialysis
Charco Joint
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
َACECR Biomedical Research Ethics Committee
Street address
ACECR Central Office, No. 1270 Enqelab Avenue
City
Tehran
Province
Tehran
Postal code
4364 - 14155
Approval date
2018-01-07, 1396/10/17
Ethics committee reference number
IR.ACECR.REC.1396.2
Health conditions studied
1
Description of health condition studied
Chronic diabetic foot Ulcer
ICD-10 code
E11.621
ICD-10 code description
Type 2 diabetes mellitus with foot ulcer
Primary outcomes
1
Description
Local and systemic side-effects
Timepoint
Every month up to month 6th
Method of measurement
Clinical examination
2
Description
Complete wound healing during study (at least 6 months)
Timepoint
Every month up to month 6th
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the volunteers who will receive adipose drived mesenchymal stem cells in one session.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
ٌWound Healing Center, ACECR of Tehran University of Medical Sciences Branch
Full name of responsible person
Gholamreza Esmaeeli Djavid
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6698 9110
Fax
+98 21 6648 8973
Email
djavid@ut.ac.ir
Web page address
http://jdtums.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Seyed Mehdi Tabaie
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6640 4720
Fax
+98 21 6640 4720
Email
smtabaie@yahoo.com
Web page address
http://jdtums.ir/
Grant name
Official Center of ACECR
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
68
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
2
Sponsor
Name of organization / entity
Helal Iran Pharmaceutic and Clinical Complex
Full name of responsible person
Hamidreza Chobineh
Street address
Tehranparsو Jashnvareh streetو Seyed Shohada
City
Tehran
Province
Tehran
Postal code
1234567891
Phone
+98 21 7733 6006
Fax
+98 21 7733 6006
Email
hchobineh@tums.ac.ir
Web page address
http://www.helalclinic.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Helal Iran Pharmaceutic and Clinical Complex
Proportion provided by this source
38
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
Iranian academic center for education culture and research
Full name of responsible person
Gholamreza Esmaeeli Djavid
Position
MD-PhD/ Director
Latest degree
Ph.D.
Other areas of specialty/work
Biophysics
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6698 9110
Fax
+98 21 6698 9110
Email
djavid@ut.ac.ir
Web page address
http://jdtums.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Seyed Mehdi Tabaie
Position
Head of TUMS Branch of ACECR
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6640 4720
Fax
+98 21 6640 4720
Email
smtabaie@yahoo.com
Web page address
http://jdtums.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Zahra Torabi Nasaj
Position
Adiminstration
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6698 9110
Fax
+98 21 6640 4720
Email
hosna_nassaj@yahoo.com
Web page address
http://jdtums.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All NA data will be accessible after publication.
When the data will become available and for how long
Time duration for access to the data will begin after publication for 2 years.
To whom data/document is available
Academic faculty member
Under which criteria data/document could be used
Systematic review and meta-analysis
From where data/document is obtainable
Contact with scientific correspondence of the project
What processes are involved for a request to access data/document