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

Universidad Autónoma de Bucaramanga

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Foot Ulcer, Diabetic

Treatments: Other: MSCs; Other: dac-MSCs; Drug: Fitostimoline

Study type: Interventional

Funder types: Other

Identifiers

NCT02943486

124174455522

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 51 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 3 patient groups

dac-MSCs and Fitostimoline

Experimental group

Description:

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

Treatment:

Drug: Fitostimoline

Other: dac-MSCs

MSCs and Fitostimoline

Active Comparator group

Description:

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

Treatment:

Drug: Fitostimoline

Other: MSCs

Fitostimoline

Active Comparator group

Description:

Topical application of fitostimoline every other day

Treatment:

Drug: Fitostimoline