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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02943486
Recruitment Status : Unknown
Verified October 2016 by Claudia Lucia Sossa Melo, Universidad Autónoma de Bucaramanga.
Recruitment status was:  Not yet recruiting
First Posted : October 24, 2016
Last Update Posted : October 24, 2016
Sponsor:
Collaborators:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Information provided by (Responsible Party):
Claudia Lucia Sossa Melo, Universidad Autónoma de Bucaramanga

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.

Condition or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Other: dac-MSCs Other: MSCs Drug: Fitostimoline Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesenchymal Stromal Cell Derivatives: a New Alternative and Potential Product for the Treatment of Diabetic Foot Ulcers 1 and 2
Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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 Name: Cell-free therapy

Drug: Fitostimoline
Triticum vulgare
Other Name: 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
Other: MSCs
Cell-based therapy
Other Name: Cell-based therapy

Drug: Fitostimoline
Triticum vulgare
Other Name: Triticum vulgare

Active Comparator: Fitostimoline
Topical application of fitostimoline every other day
Drug: Fitostimoline
Triticum vulgare
Other Name: Triticum vulgare




Primary Outcome Measures :
  1. Wound size change [ Time Frame: One year ]
    Wound size will be assessed using a SilhouetteMobile camera (digital planimetry)


Secondary Outcome Measures :
  1. Granulation tissue percentage [ Time Frame: One year ]
    Images will be used to assess the amount of granulation tissue present in the wound

  2. Pigmentation change [ Time Frame: One year ]
    Digital images will be used to evaluate color changes in the wound

  3. Presence of Exudate [ Time Frame: One year ]
    Visual observation of the wound to determine the presence of exudate



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943486


Contacts
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Contact: Claudia L Sossa-Melo, MD +57 7 643 6261 ext 587 claudiasossa@gmail.com
Contact: Martha L Arango-Rodríguez, Ph.D. +57 679 7979 ext 6086 martha.arango@fosunab.com

Sponsors and Collaborators
Universidad Autónoma de Bucaramanga
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Investigators
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Principal Investigator: Claudia L Sossa-Melo, MD Universidad Autónoma de Bucaramanga

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Responsible Party: Claudia Lucia Sossa Melo, Associate Professor, Universidad Autónoma de Bucaramanga
ClinicalTrials.gov Identifier: NCT02943486    
Other Study ID Numbers: 124174455522
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Claudia Lucia Sossa Melo, Universidad Autónoma de Bucaramanga:
Mesenchymal stromal cells
Fitostimoline
MSC derivatives
Diabetes
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases