Clinical trial NCT02943486: Mesenchymal Stromal Cell Derivatives in the Treatment of Chronic Diabetic Foot Ulcers Type 1 and 2
Official title: Mesenchymal Stromal Cell Derivatives: a New Alternative and Potential Product for the Treatment of Diabetic Foot Ulcers 1 and 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Foot Ulcer, Diabetic
Keywords: Mesenchymal stromal cells
Fitostimoline
MSC derivatives
Diabetes
Lead sponsor: Universidad Autónoma de Bucaramanga
Sponsor class: OTHER
Collaborators: name: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
First posted: 2016-10-24
Enrollment: 51
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Wound size change
timeFrame: One year
Secondary outcomes:
measure: Granulation tissue percentage
timeFrame: One year
measure: Pigmentation change
timeFrame: One year
measure: Presence of Exudate
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Autónoma de Bucaramanga
name: Claudia L Sossa-Melo, MD
role: PRINCIPAL_INVESTIGATOR
References: