Mesenchymal Stromal Cell Derivatives in the Treatment of Chronic Diabetic Foot Ulcers Type 1 and 2 (MSCDTDFU)

Mesenchymal Stromal Cell Derivatives: a New Alternative and Potential Product for the Treatment of Diabetic Foot Ulcers 1 and 2

Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

The goal of this study is to evaluate the safety and efficacy of using mesenchymal stromal cell derivatives (dac-MSCs) in the treatment of chronic diabetic foot ulcers (type 1 and 2) in adults. A third of the participants will receive dac-MSCs and Triticum vulgare (Fitostimoline) in combination, the other third MSCs and Fitostimoline in combination, and the last third only Fitosimoline. This study will be a randomized, blind, and parallel and controlled-group trial.

Conventional treatments such as dry, wet or active dressings are effective only in 50% of patients with diabetic foot ulcer. The remaining 50% of patients have non-responding recoveries that leads to amputation of the compromised limbs. Currently, the administration of mesenchymal stem cells (MSCs) in animal models or in small groups of patients with diabetic foot ulcer has shown to be safe and effective. Particularly, the use of these cells induce regeneration, both in the dermis and the epidermis. Nevertheless, MSC transplantation has some limitations, for instance, time restrictions in the availability of cells due to their isolation and expansion as well as the complex and costly large-scale production. In the same manner, the cryopreservation might cause deleterious effects that affect the biological activity of the cells and a medical professional should conduct the cell administration. In addition, different studies report variability in the results due to the inconsistency in the methods that they used (extraction protocols, cultivation, expansion and administration). The investigators' recent studies in mice with skin lesions, particularly type 1 diabetes, have shown that the presence of the cells is not necessary to promote skin regeneration and the administration of dac-MSCs is sufficient to stimulate would healing.

Intradermic application of dac-MSCs (1 mL ) in four equidistant points around the ulcer (twice: day 0 and 7) and topical application of fitostimoline every other day

Intradermic application of MSCs (500,000 cells/mL) in four equidistant points around the ulcer (once: day 0 ) and topical application of fitostimoline every other day

Inclusion Criteria: Males and females between the ages of 40 and 80 years, inclusive, with Type 1 or 2 diabetes as defined by the American Diabetes Association Stable glycemic control Transcutaneous oxygen measurement > 30 mmHg Ulcer present at least for 1 month Wound size between 0.5 and 5 cm2 Subjects that require endovascular surgical intervention Subjects must have adequate nutrition (albumin level > 2 g/dL and prealbumin level > 15 mg/dL) Exclusion Criteria: Previous or current diagnoses with one of the following: cancer, symptomatic coronary artery disease, brain disease, kidney failure, blood disorders Taking immunosuppressive and cytotoxic drugs Presence of active systemic infection