Erectile dysfunction (ED) is defined as the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance. It significantly affects physical health, psychological well-being, and quality of life of both the patient and his partner. Organic forms of ED are commonly associated with vascular, neurogenic, metabolic, and hormonal disorders.
Currently, the main methods of treatment for ED include the use of phosphodiesterase type 5 inhibitors, local therapies such as vacuum devices, intracavernosal and transurethral pharmacotherapy, and surgical implantation of penile prostheses in severe cases. Since 2010, low-intensity radial shock wave therapy has also been actively used. However, each of these methods has limitations, including variable efficacy, invasiveness, temporary effects, or associated adverse events, which highlights the need for the development of new therapeutic approaches.
With the advancement of regenerative medicine and cellular technologies, a promising strategy for the treatment of organic ED has emerged, involving the use of autologous mesenchymal stem cells (MSCs) derived from bone marrow and adipose tissue. These cells have demonstrated regenerative, angiogenic, anti-inflammatory, and antifibrotic properties, primarily mediated through paracrine mechanisms and secretion of growth factors that support tissue repair and neovascularization.
An analysis of the available literature indicates that both preclinical and clinical studies support the safety and potential efficacy of MSC-based therapy in ED. However, there is currently a lack of prospective comparative clinical studies evaluating the efficacy and safety of bone marrow-derived versus adipose tissue-derived autologous MSCs in human subjects.
This study is designed as a prospective, controlled clinical investigation to evaluate and compare different regenerative treatment approaches in patients with organic ED. A total of approximately 100 male participants aged 18-70 years with a confirmed diagnosis of organic ED will be included.
Participants will be allocated into five groups:
Patients receiving intracavernosal administration of autologous bone marrow-derived mesenchymal stem cells Patients receiving intracavernosal administration of adipose tissue-derived mesenchymal stromal cells Patients receiving intracavernosal administration of autologous platelet-rich plasma (PRP), 4 mL dose Patients receiving intracavernosal administration of autologous platelet-rich plasma (PRP), 6 mL dose Control group receiving standard conservative therapy according to national clinical guidelines, supplemented with low-intensity radial shock wave therapy
All interventions will be performed under standardized conditions. Autologous biological materials (bone marrow, adipose tissue, and blood for PRP preparation) will be collected, processed, and administered according to established laboratory and clinical protocols.
Baseline assessment will include clinical examination, laboratory testing, hormonal profiling, and instrumental diagnostic methods such as penile Doppler ultrasonography. Erectile function and treatment outcomes will be evaluated using validated assessment tools, including the International Index of Erectile Function-5 (IIEF-5) questionnaire as the primary measure. Additional validated instruments will include the Sexual Encounter Profile (SEP), Erection Hardness Score (EHS), and Global Assessment Questionnaire (GAQ), as well as quality-of-life assessments related to sexual health.
Follow-up assessments will be conducted at predefined time points (1, 3, 6, and 12 months after intervention) to evaluate changes in erectile function, treatment response, and safety outcomes.
The primary objective of the study is to assess and compare the efficacy of the different treatment modalities in improving erectile function. Secondary objectives include evaluation of safety, changes in penile hemodynamics, patient-reported outcomes, and incidence of adverse events.
This study represents the first prospective comparative clinical investigation in the Kazakh population assessing the use of autologous bone marrow-derived MSCs, adipose-derived MSCs, and PRP therapy (at two different doses), in comparison with standard treatment for organic ED. The results are expected to contribute to the development of more effective and regenerative treatment strategies for patients with erectile dysfunction.
