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The transition of science into medical practice is a complex process that involves transforming scientific discoveries made in labs into real medical treatments.
A clinical trial is a scientific study designed to evaluate the safety and efficiency of a new potential drug or a new way of applying an existing treatment. Trials help better understand the disease and select treatment regimens that take into account all the individual characteristics of the patient to achieve a positive result.
Phase 1. At this point, the main question is: "Is the new treatment safe?" The study is conducted on a small group of volunteers and is aimed to determine the safety, optimal dose, and side effects of the new treatment.
Phase 2. Its purpose is to estimate whether the treatment is safe and effective enough to continue the study. Research is conducted on a larger group of volunteers.
Phase 3. This phase helps understand if the new treatment works on a larger group of volunteers. The study evaluates the effectiveness and side effects of the new treatment in a large group of people and compares it to the traditional treatment regimens.
Phase 4. At this stage, the researchers gather the results of long-term observation. A continuous follow-up on patients receiving new treatment can last up to several years and highlights the risks and benefits of a new treatment in the long run.
Clinical trials of mesenchymal stem cells
During 2011-2018, more than 950 clinical trials based on the use of mesenchymal stem cells (MSCs) were registered worldwide. The most significant therapeutic effect of MSCs has been shown to treat graft-versus-host disease (GVHD), complex forms of fistulas in Crohn's disease, osteoarthritis, and type 2 diabetes. In Canada and New Zealand, "prochymal" MSCs have been approved to treat severe GVHD in steroid-resistant children.
Phase of MSCs clinical trials
Most clinical trials on MSCs are in phase 1-2.
Among all the types of MSCs currently in clinical trials, there are MSCs isolated from bone marrow, adipose tissue, and umbilical cord predominate.
The largest number of clinical trials has been registered for:
● neurodegenerative diseases with a predominance of spinal cord injuries and multiple sclerosis;● diseases of the joints with a predominance of osteoarthritis and rheumatoid arthritis;● diseases of the cardiovascular system;● autoimmune diseases.
Results of MSCs clinical trials: