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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stem Cell Transplant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diabetic patient with diagnosis of neuropathic or neuro-ischemic DFU
  2. 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)
  3. Strict diabetes control with HbA1c ≤ 7.5%
  4. 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

    First Posted
    August 21, 2017
    Last Updated
    August 21, 2017
    Sponsor
    Assiut University
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    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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