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

NCT ID: NCT02943486

Last Updated: 2016-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-01-31

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.

Conditions

Foot Ulcer, Diabetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dac-MSCs and Fitostimoline

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

Group Type: EXPERIMENTAL

dac-MSCs

Intervention Type: OTHER

Cell-free therapy

Fitostimoline

Intervention Type: DRUG

Triticum vulgare

MSCs and Fitostimoline

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

Group Type: ACTIVE_COMPARATOR

MSCs

Intervention Type: OTHER

Cell-based therapy

Fitostimoline

Intervention Type: DRUG

Triticum vulgare

Fitostimoline

Topical application of fitostimoline every other day

Group Type: ACTIVE_COMPARATOR

Fitostimoline

Intervention Type: DRUG

Triticum vulgare

Interventions

dac-MSCs

Cell-free therapy

Intervention Type: OTHER

MSCs

Cell-based therapy

Intervention Type: OTHER

Fitostimoline

Triticum vulgare

Intervention Type: DRUG

Other Intervention Names

Cell-free therapy; Cell-based therapy; Triticum vulgare

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

OTHER

Sponsor Role: collaborator

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

OTHER_GOV

Sponsor Role: collaborator

Universidad Autónoma de Bucaramanga

OTHER

Sponsor Role: lead

Responsible Party

Claudia Lucia Sossa Melo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia L Sossa-Melo, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Autónoma de Bucaramanga

Central Contacts

Claudia L Sossa-Melo, MD

Role: CONTACT

claudiasossa@gmail.com

+57 7 643 6261 ext. 587

Martha L Arango-Rodríguez, Ph.D.

Role: CONTACT

martha.arango@fosunab.com

+57 679 7979 ext. 6086

Other Identifiers

124174455522

Identifier Type: -

Identifier Source: org_study_id