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

October 21, 2016 updated by: Claudia Lucia Sossa Melo, Universidad Autónoma de Bucaramanga

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

51

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: dac-MSCs
Cell-free therapy
Other Names:
  • Cell-free therapy
Drug: Fitostimoline
Triticum vulgare
Other Names:
  • Triticum vulgare
Active Comparator: 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
Drug: Fitostimoline
Triticum vulgare
Other Names:
  • Triticum vulgare
Other: MSCs
Cell-based therapy
Other Names:
  • Cell-based therapy
Active Comparator: Fitostimoline
Topical application of fitostimoline every other day
Drug: Fitostimoline
Triticum vulgare
Other Names:
  • Triticum vulgare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound size change
Time Frame: One year
Wound size will be assessed using a SilhouetteMobile camera (digital planimetry)
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Granulation tissue percentage
Time Frame: One year
Images will be used to assess the amount of granulation tissue present in the wound
One year
Pigmentation change
Time Frame: One year
Digital images will be used to evaluate color changes in the wound
One year
Presence of Exudate
Time Frame: One year
Visual observation of the wound to determine the presence of exudate
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autónoma de Bucaramanga

Collaborators

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

Investigators

  • Principal Investigator: Claudia L Sossa-Melo, MD, Universidad Autonoma de Bucaramanga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 21, 2016

First Posted (Estimate)

October 24, 2016

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124174455522

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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