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

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Autónoma de Bucaramanga
• Collaborators: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle; Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Criteria

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