A Phase 1/2 interventional study of dac-MSCs and MSCs in Foot Ulcer, Diabetic, sponsored by Universidad Autónoma de Bucaramanga. Status unknown. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-24.
Sponsored by Universidad Autónoma de Bucaramanga · Phase 1/2, Interventional, and Treatment
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.
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 51 is below the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Universidad Autónoma de Bucaramanga is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: 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 · Drug: Fitostimoline
Topical application of fitostimoline every other day
Drug: Fitostimoline
Cell-free therapy
Also known as: Cell-free therapy
Cell-based therapy
Also known as: Cell-based therapy
Triticum vulgare
Also known as: Triticum vulgare
Wound size change
Wound size will be assessed using a SilhouetteMobile camera (digital planimetry)
Time frame: One year
Granulation tissue percentage
Images will be used to assess the amount of granulation tissue present in the wound
Time frame: One year
Pigmentation change
Digital images will be used to evaluate color changes in the wound
Time frame: One year
Presence of Exudate
Visual observation of the wound to determine the presence of exudate
Time frame: One year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jan 2017, a primary completion of Jun 2018 and a completion of Jan 2019. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Universidad Autónoma de Bucaramanga