Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot Ulcers
Primary Purpose
Stem Cell Transplant
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Stem Cell Product
Sponsored by
About this trial
This is an interventional treatment trial for Stem Cell Transplant
Eligibility Criteria
Inclusion Criteria:
- Diabetic patient with diagnosis of neuropathic or neuro-ischemic DFU
- Chronic non healed diabetic foot ulcer (The wound was determined as non-healing and chronic when the wound was treated with current standard care for diabetic foot ulcer by a wound care specialist for at least 3 months prior to the therapy with less than 40% of wound closure)
- Strict diabetes control with HbA1c ≤ 7.5%
- Grade 1 or 2 ulcer on the Wagner scale
Exclusion Criteria:
- 1- Critical ischemia of the target limb, defined by pain at rest and an ankle systolic pressure < 50 mm Hg, or a toe systolic pressure < 30 mm Hg 2- DFU clinically infected as defined by the IDSA/IWGDF criteria, osteomyelitis confirmed by MRI, or other evidence of infection is present 3- Surgery or surgical revascularisation < 2months 4- Collagen tissue diseases , malignant and hematological diseases onset of myocardial infarction or cerebral infarction within the last 6 months
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stem cell product
Arm Description
stem cell transplant
Outcomes
Primary Outcome Measures
complete healing
full epithelization of chronic diabetic foot ulcer
Secondary Outcome Measures
Rate of healing
percentage of patients achieving 50 % wound closure
rate of ulcer recurrence
percentage of patients whose ulcer recurred
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03259217
Brief Title
Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot Ulcers
Official Title
Prospects of Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2017 (Anticipated)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will assess the efficacy of application of stem cell in healing of chronic diabetic foot ulcer
Detailed Description
Diabetic foot ulcers are a significant and rapidly growing complication of diabetes and its effects on wound healing. Over half of diabetic patients who develop a single ulcer will subsequently develop another ulcer of which the majority will become chronic non-healing ulcers. Over the past decade, the outcomes for patients with ulcers have not improved, despite advances in wound care.These data suggest the importance and necessity of alternative and more effective treatment option for diabetic patients with non-healing ulcers. (Blumberg et al 2012). Stem cell therapy has emerged as a novel therapeutic approach for various diseases including wound repair and tissue regeneration. Mesenchymal stem cells(MSCs) represent an important stem cell population with multipotent capabilities that may have high utility for translational clinical applications. MSCs can differentiate into a variety of cell types, especially fascia originated cells, and provide soluble factors for regeneration of tissues and organs(Şener et al 2015). Adipose tissue is an abundant source of mesenchymal stem cells, which have shown an improved outcome in wound healing studies. Adipose tissue derived stem cells (ASCs )are pluripotent stem cells with the ability to differentiate into different lineages and to secrete paracrine factors initiating tissue regeneration process. The abundant supply of fat tissue, ease of isolation, extensive proliferative capacities ex vivo, and their ability to secrete pro-angiogenic growth factors make them an ideal cell type to use in therapies for the treatment of nonhealing wounds(Hassan et al 2014), However the hostile microenviroment may interfere with viability and efficiency of MSCs injection specially in ischemic tissue , thus increasing needs for new strategies for further improvement of the stem cell therapy of diabetic wounds. Curcumin loaded chitosan nanoparticles into collagen-alginate is a novel biodegradable and biocompatible material that might help a lot in regenerative efficiency in ischemic wound healing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell Transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stem cell product
Arm Type
Experimental
Arm Description
stem cell transplant
Intervention Type
Drug
Intervention Name(s)
Stem Cell Product
Other Intervention Name(s)
mesenchymal stem cells
Intervention Description
Adipose tissue derived mesenchymal stem cell seeded in Curcumin loaded chitosan nanoparticles into collagen-alginate
Primary Outcome Measure Information:
Title
complete healing
Description
full epithelization of chronic diabetic foot ulcer
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rate of healing
Description
percentage of patients achieving 50 % wound closure
Time Frame
6 months
Title
rate of ulcer recurrence
Description
percentage of patients whose ulcer recurred
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic patient with diagnosis of neuropathic or neuro-ischemic DFU
Chronic non healed diabetic foot ulcer (The wound was determined as non-healing and chronic when the wound was treated with current standard care for diabetic foot ulcer by a wound care specialist for at least 3 months prior to the therapy with less than 40% of wound closure)
Strict diabetes control with HbA1c ≤ 7.5%
Grade 1 or 2 ulcer on the Wagner scale
Exclusion Criteria:
1- Critical ischemia of the target limb, defined by pain at rest and an ankle systolic pressure < 50 mm Hg, or a toe systolic pressure < 30 mm Hg 2- DFU clinically infected as defined by the IDSA/IWGDF criteria, osteomyelitis confirmed by MRI, or other evidence of infection is present 3- Surgery or surgical revascularisation < 2months 4- Collagen tissue diseases , malignant and hematological diseases onset of myocardial infarction or cerebral infarction within the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walaa Khalifa, MD
Phone
+20882303620
Email
dr.walaaanwar@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walaa Khalifa, MD
Organizational Affiliation
lecturer
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
1-Blumberg SN1, Berger A, Hwang L, Pastar I, Warren SM, Chen W: The role of stem cells in the treatment of diabetic foot ulcers,Diabetes Res Clin Pract. 2012 Apr;96(1):1-9. 2-Hassan WU1, Greiser U, Wang W . Role of adipose-derived stem cells in wound healing Wound Repair Regen. 2014 May-Jun;22(3):313-25 3-Şener LT, Albeniz I1 . Challenge of Mesenchymal Stem Cells Against Diabetic Foot Ulcer : Curr Stem Cell Res Ther. 2015;10(6):530-4.
Results Reference
result
Learn more about this trial
Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot Ulcers
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