Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot Ulcers

Stem Cell Transplant Clinical Trial

Official title:

Prospects of Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot Ulcers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03259217
• Other study ID #: stem cell in DFU
• Status: Not yet recruiting
• Phase: Phase 1
• First received: August 21, 2017
• Last updated: August 21, 2017
• Start date: October 2017
• Est. completion date: January 2019

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Walaa Khalifa, MD
• Phone: +20882303620
• Email: dr.walaaanwar[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy of application of stem cell in healing of chronic diabetic foot ulcer

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Stem Cell Transplant

Intervention

Drug:
• Stem Cell Product
Adipose tissue derived mesenchymal stem cell seeded in Curcumin loaded chitosan nanoparticles into collagen-alginate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

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 heal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete healing	full epithelization of chronic diabetic foot ulcer	6 months
Secondary	Rate of healing	percentage of patients achieving 50 % wound closure	6 months
Secondary	rate of ulcer recurrence	percentage of patients whose ulcer recurred	one year