About the project
Diabetes mellitus is a severe metabolic disease with a high incidence and an increasing prevalence (keep!…) in the population. Diabetic foot and its complications, including diabetic ulcers, are among the common complications of advanced diabetes. About 15% of diabetics develop this complication during their lifetime which may even progress to formation of chronic ulcers.
Despite advances in the diagnostics and treatment of diabetic complications, the treatment of chronic ulcers is difficult, not always successful, and more than one third of these cases leads to the need for amputation of the affected extremity. Current treatment protocols recommend standard treatment for diabetic foot ulcers, but it has been shown that biological treatment in combination with conventional care leads to improved healing of diabetic ulcerations.
Treatment of diabetic foot with stem cells is one of the promising potential methods. According to the clinical trial database, several clinical trials of stem cell use in patients with diabetes mellitus have been initiated, are ongoing or have been conducted. However, the common denominator of the studies is the application of individual stem cells.
The DIASTEM project aims to carry out a clinical study and assess the possibilities of using stem cell therapy in combination with other forms of biological treatment, using larval therapy and experimental phage therapy. While larval therapy is commonly used in advanced ulcers, phage therapy is less known. Only a few studies of the use of phage cocktails in humans in the treatment of skin infections with promising results have been documented.
The DIASTEM project is based on current scientific knowledge in the field of the use of stem cells in the therapy of diseases. It builds on recent clinical studies and takes their findings into account. We hypothesize that it is the synergistic effect of several forms of biological treatment that can positively influence the effectiveness and efficacy of treatment and can have positive consequences for the patient.
The aim of the project is to verify the possibilities of using stem cells (safety and efficacy) in the treatment of chronic diabetic ulcers in combination with other treatments with regard to different degrees of impairment.
- prepare recommendations for the treatment of diabetic ulcer in accordance with the most recent learnings and experimental methodologies
- to propose a new methodology for monitoring the healing process based on metagenomic analyzes using this method to supplement the clinical picture in monitoring the progress of treatment in patients.
- characterize the use of phage cocktail preparations using whole genome.
Subject of the project
The subject of the project is to conduct a clinical study and assess the possibilities of using stem cell therapy in combination with other forms of biological treatment, using larval therapy and experimental phage therapy.
Stage 1: Recruitment of patients to a clinical study
With respect to incidence of diabetic foot, we conservatively estimate that recruitment to the groups will be completed within three years of project implementation. Nemocničná, a.s. will be responsible for recruiting patients, informing patients and obtaining informed consent
Planned completion of the stage: 12/2020
Stage 2: Application of treatment
Administration of treatment to patients will be performed parallel to stage 1 according to the designed clinical study protocol. Medirex Group Academy will be responsible for preparing the stem cell specimen for application, but UVP will be responsible for preparing the phage therapy. Basic clinical testing of patients, administration and monitoring of treatment will be carried out in the medical facility Nemocničná, a.s.
Planned completion of the stage: 12/2021 + continuous subsequent long-term monitoring of patients
Stage 3: Research and development of treatment monitoring methodology based on microbiome analysis
The analysis of the microbiome and the development of the treatment monitoring methodology based on microbiome analysis in patients will be carried out parallel to stage 2 in accordance with the designed protocol of the clinical study. UVP will be responsible for the implementation of this stage.
The stage will be conducted in the following sub-stages:
- Stage 3.1 Introduction and optimization of the method
- Stage 3.2 Testing on samples from the study, creating a database of the results
- Step 3.3 Creation and fine-tuning of the bioinformatics ipeline
- Stage 3.4 Implementation of project sample analyses
Planned completion of the stage: 12/2021
Stage 4: Analysis of study results
We assume that the results of the study will be analyzed and published in the last year of project implementation. The analysis of long-term patient monitoring will continue continually after completion of the study.
- proposal of new treatment procedures for diabetic foot,
- comparison of new treatments based on innovative methods with the anticipated increase in treatment effeicacy and fewer side effects compared to conventional therapy,
- clinical recommendations for the treatment of diabetic foot,
- more effective therapy can ultimately significantly reduce the cost of treating patients with diabetic foot. We anticipate that more effective treatment will reduce the need for leg amputations in the advanced cases of diabetic ulcer,
- new method for monitoring the treatment of diabetic foot based on microbiome analysis – metagenomics