Cell Therapy of Vascular and Neuropathic Complications of Diabetes: Can We Avoid Limb Amputation?

Author:

Soria Bernat123ORCID,Escacena Natalia4ORCID,Gonzaga Aitor12,Soria-Juan Barbara5,Andreu Etelvina16,Hmadcha Abdelkrim78,Gutierrez-Vilchez Ana Maria29ORCID,Cahuana Gladys8,Tejedo Juan R.38ORCID,De la Cuesta Antonio10,Miralles Manuel11,García-Gómez Susana12,Hernández-Blasco Luis1

Affiliation:

1. Institute of Biomedical Research ISABIAL of the University Miguel Hernández, Dr. Balmis General and University Hospital, 03010 Alicante, Spain

2. Institute of Bioengineering, University Miguel Hernández, 03202 Elche, Spain

3. CIBERDEM Network Research Center for Diabetes and Associated Metabolic Diseases, Carlos III Health Institute, 28029 Madrid, Spain

4. Fresci Consultants, Human Health Innovation, 08025 Barcelona, Spain

5. Reseaux Hôpitalieres Neuchatelois et du Jura, 2000 Neuchâtel, Switzerland

6. Department of Applied Physics, University Miguel Hernández Elche, 03202 Elche, Spain

7. Biosanitary Research Institute (IIB-VIU), Valencian International University (VIU), 46002 Valencia, Spain

8. Department of Molecular Biology, University Pablo de Olavide, 41013 Sevilla, Spain

9. Department of Pharmacology, Pediatrics and Organic Chemistry, University Miguel Hernández, 03202 Elche, Spain

10. Hospital Victoria Eugenia, Cruz Roja, 41009 Sevilla, Spain

11. University and Polytechnic Hospital La Fe, 46026 Valencia, Spain

12. Cell Therapy Centre, Nottingham Trent University, Nottingham NG1 4FQ, UK

Abstract

Globally, a leg is amputated approximately every 30 seconds, with an estimated 85 percent of these amputations being attributed to complications arising from diabetic foot ulcers (DFU), as stated by the American Diabetes Association. Peripheral arterial disease (PAD) is a risk factor resulting in DFU and can, either independently or in conjunction with diabetes, lead to recurring, slow-healing ulcers and amputations. According to guidelines amputation is the recommended treatment for patients with no-option critical ischemia of the limb (CTLI). In this article we propose cell therapy as an alternative strategy for those patients. We also suggest the optimal time-frame for an effective therapy, such as implanting autologous mononuclear cells (MNCs), autologous and allogeneic mesenchymal stromal cells (MSC) as these treatments induce neuropathy relief, regeneration of the blood vessels and tissues, with accelerated ulcer healing, with no serious side effects, proving that advanced therapy medicinal product (ATMPs) application is safe and effective and, hence, can significantly prevent limb amputation.

Funder

Project of Excellence of the Ministry of Innovation, Science and Business of the Junta de Andalucía

INNPACTO project of the Ministry of Economy and Competitiveness

European Commission

Cell Therapy Network

FIS

PI

Specific financing for Clinical Trials within the Advanced Therapies program of the Ministry of Health, Equality and Social Welfare, Carlos III Health Institute

NOMA

DECODE Trials

BIOREG project of the SUDOE Program of the European Commission

Generalitat Valenciana

ACTION COST of the European Commission

University Miguel Hernández de Elche

Publisher

MDPI AG

Subject

Inorganic Chemistry,Organic Chemistry,Physical and Theoretical Chemistry,Computer Science Applications,Spectroscopy,Molecular Biology,General Medicine,Catalysis

Reference91 articles.

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2. Magliano, D.J., and Boyko, E.J. (2021). IDF Diabetes Atlas, IDF Diabetes Atlas 10th Edition Scientific Committee.

3. Nutrition could prevent or promote non-alcoholic fatty liver disease: An opportunity for intervention;Bugianesi;BMJ (Clin. Res. Ed.),2023

4. Costes directos de la diabetes mellitus y de sus complicaciones en España (Estudio SECCAID: Spain estimated cost Ciberdem-Cabimer in Diabetes);Crespo;Av. Diabetol.,2013

5. Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease;Barnes;Arterioscler. Thromb. Vasc. Biol.,2020

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