Protocol summary
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Study aim
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Evaluation of Safety and Effectivness of Expanded Allogenic Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer
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Design
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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 Menstrual blood 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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Intervention group is the injection of allogenic mesenchymal stem cells in one session.
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Main outcome variables
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1) Local and systemic side effects
2) complete healing rate
General information
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Reason for update
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Due to the limitation of achieving healthy volunteers donating adipose tissue and the lack of GMP standardization by the clean room of Helal Medical Complex, the source of mesenchymal stem cells (MSCs) was changed to the commercial MSCs product (SinaBioMBcells) ontained from Avecina Institute.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170612034485N2
Registration date:
2018-02-11, 1396/11/22
Registration timing:
prospective
Last update:
2020-05-23, 1399/03/03
Update count:
1
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Registration date
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2018-02-11, 1396/11/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-03-21, 1398/01/01
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Expected recruitment end date
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2020-08-22, 1399/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of Safety and Effectiveness of Expanded Allogenic Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer (Phase I/II Clinical Trail)
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Public title
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Allogenic stem cell in diabetic wound
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
20
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-07, 1396/10/17
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Ethics committee reference number
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IR.ACECR.REC.1396.2
Health conditions studied
1
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Description of health condition studied
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Chronic diabetic foot Ulcer
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ICD-10 code
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E11.621
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ICD-10 code description
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Type 2 diabetes mellitus with foot ulcer
Primary outcomes
1
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Description
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Local and systemic side-effects
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Timepoint
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Every month up to month 6th
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Method of measurement
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Clinical examination
2
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Description
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Complete wound healing during study (at least 6 months)
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Timepoint
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Every month up to month 6th
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Method of measurement
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Clinical examination
Intervention groups
1
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Description
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Intervention group: the volunteers who will receive allogenic mesenchymal stem cells in one session.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Official Center of ACECR
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iranian academic center for education culture and research
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Proportion provided by this source
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68
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Academic Center for Education, Culture and Research (ACECR)
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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All NA data will be accessible after publication.
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When the data will become available and for how long
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Time duration for access to the data will begin after publication for 2 years.
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To whom data/document is available
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Academic faculty member
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Under which criteria data/document could be used
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Systematic review and meta-analysis
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From where data/document is obtainable
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Contact with scientific correspondence of the project
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What processes are involved for a request to access data/document
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via written request letter
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Comments
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