Clinical trial NCT03259217: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stem Cell Transplant
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: complete healing
timeFrame: 6 months
Secondary outcomes:
measure: Rate of healing
timeFrame: 6 months
measure: rate of ulcer recurrence
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: lecturer
name: Walaa Khalifa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sener LT, Albeniz I. Challenge of Mesenchymal Stem Cells Against Diabetic Foot Ulcer. Curr Stem Cell Res Ther. 2015;10(6):530-4. doi: 10.2174/1574888x10666150519092931.