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

Foot Ulcer, Diabetic Clinical Trial

— MSCDTDFU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02943486
• Other study ID #: 124174455522
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: October 19, 2016
• Last updated: October 21, 2016
• Start date: January 2017
• Est. completion date: January 2019

Study information

• Verified date: October 2016
• Source: Universidad Autónoma de Bucaramanga
• Contact: Claudia L Sossa-Melo, MD
• Phone: +57 7 643 6261
• Email: claudiasossa[@]gmail.com
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: January 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

Other:
• dac-MSCs
Cell-free therapy
• MSCs
Cell-based therapy

Drug:
• Fitostimoline
Triticum vulgare

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound size change	Wound size will be assessed using a SilhouetteMobile camera (digital planimetry)	One year	Yes
Secondary	Granulation tissue percentage	Images will be used to assess the amount of granulation tissue present in the wound	One year	Yes
Secondary	Pigmentation change	Digital images will be used to evaluate color changes in the wound	One year	Yes
Secondary	Presence of Exudate	Visual observation of the wound to determine the presence of exudate	One year	Yes