According to the overall data about 30% of males are seriously disturbed by Erectile Dysfunction (ED) which is the manifestation of Androgen Deficiency (AD). Quite often erectile disorders appear along with various chronic diseases and, sometimes, it can be the first symptom of such a disease as Diabetes Mellitus type 2 (DM-2). The frequency of AD development correlates not only with patient’s age, but also with severity and term of DM, as well as with the level of disease correction. The main reason for AD development in DM-2 patients is the decline in serum concentration level of leading androgen, the testosterone (T). It’s the proven fact, that T-level in DM-2 patients is significantly lower than in healthy males of the same age. It is also proven, that Hormone Replacement Therapy (HRT) for AD correction in DM-2 patients is necessary for considerable improvement of patients’ quality of life. However, HRT has got certain advantages and disadvantages like any other kind of therapy. T-therapy demands the adherence to certain rules and safety measures. HRT requires permanent maintenance of T-level by medications intake which constitutes the inconvenience for patients, especially for working-age ones. The search for alternative methods of AD correction to maintain normal T-values, including the DM-2 patients, is extremely necessary as such. The most popular way is the Bone Marrow Stem Cells (BMSCs) treatment, since they can be obtained from adult men for the future auto-transplantation. We conducted a series of experiments to assess the efficiency and safety of the intratesticular BMSCs administration for hypogonadal state correction. It was noted, that technique is effective both for T-deficiency correction and reproductive organs regeneration. The aim of our study was the assessment of efficiency and safety of intratesticular injection of autologous BMSCs in comparison with standard HRT for AD correction in DM-2 male patients 45 – 59 years of age. In the HRT subgroup at the point of enrollment the baseline lab values compared to the control group demonstrated the decrease of T-level by 75.5%, increase of SHBG by 132.1%, decrease of FAI by 90.5%, increase of BS level by 109.8%, increase of HbA1c by 138.5%, increase of Cholesterol level by 166.0%. The total PSA level was within the normal limits and was not statistically different from the control group. The assessment of HRT after 24 weeks of treatment revealed the following results compared to baseline: T-level increased by 77.2%, SHBG decreased by 114.6%, FAI increased by 65.6%, BS level decreased by 68.6%, HbA1c decreased by 88.5%, Cholesterol level decreased by 144.0%, and total PSA level was not statistically different from baseline. Compared to the control group, the results revealed normal T-values, SHBG level was 17.5% higher, FAI was 24.1% lower, BS level was 41.2% higher, HbA1c level was 50.0% higher, Cholesterol was 22.0% higher, and total PSA values were not statistically different from control group. The HRT did not cause any complications or adverse events in our patients. In the BMSC-therapy subgroup the baseline readings compared to the control group were the following: T-level was 76.6% lower, SHBG level was 96.2% higher, FAI was 90.0% lower, BS level was 109.8% higher, HbA1c level was 134.6% higher, Cholesterol was 142.0% higher, and total PSA values were normal and were not statistically different from control group. The BMSC-therapy efficiency assessment 24 weeks later demonstrated the increase of T-level by 60.5%, decrease of SHBG by 113.3%, increase of FAI by 45.5%, BS level decrease by 49.0%, decrease of HbA1c by 82.7%, Cholesterol level decreased by 130.0%, and total PSA decreased by 13.3%. Compared to the control group, the T-level was 16.2% lower, SHBG level was 33.0% higher, FAI was 44.4% lower, BS level was 60.8% higher, HbA1c level was 51.9% higher, Cholesterol was 12.0% higher, and total PSA level was 6.7% higher. The assessment did not find any side effects of administered treatment. As a result, it was confirmed that normalizing the T-level leads to statistically significant positive adjustment of DM and Metabolic Syndrome markers just after 4 weeks of combined therapy. It should be noted that BMSC subgroup demonstrated faster beginning (4 weeks) of T-serum level elevation combined with SHBG level decline. The same tendency was preserved after 12 weeks as well, while in the HRT group the same effect required repeated injections of testosterone. There were no adverse reactions detected in both subgroups.
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