Erectile dysfunction (ED) is a common condition characterized by the inability to achieve or maintain an erection sufficient for satisfactory sexual activity. It can significantly affect physical health, emotional well-being, and quality of life for both patients and their partners. Standard treatment options include medications such as phosphodiesterase type 5 inhibitors, vacuum devices, intracavernosal or transurethral therapies, and surgical implantation of penile prostheses. In recent years, low-intensity shock wave therapy has also been introduced as a treatment option. However, these approaches may have limitations in effectiveness, invasiveness, or long-term outcomes, highlighting the need for alternative therapies.

Advances in regenerative medicine have introduced new potential treatment strategies, including the use of autologous mesenchymal stem cells derived from bone marrow or adipose tissue. These therapies aim to improve tissue repair and restore erectile function. Previous preclinical and clinical studies suggest that mesenchymal stem cell therapy may be safe and effective, but direct comparisons between different sources of stem cells remain limited.

This prospective study aims to evaluate and compare the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells, adipose tissue-derived mesenchymal stromal cells, and platelet-rich plasma (PRP) therapy in patients with organic erectile dysfunction. A control group receiving standard conservative treatment, including low-intensity shock wave therapy, will also be included.

The study will be conducted in a population of patients in Kazakhstan and will assess outcomes before and after treatment to determine improvements in erectile function and overall patient well-being. The results may help identify more effective and regenerative treatment approaches for patients with organic erectile dysfunction.

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.

Inclusion Criteria

• Male sex, aged between 18 and 70 years.
• Confirmed diagnosis of organic erectile dysfunction (e.g., vasculogenic, diabetic, or post-traumatic) for a duration of at least 6 months.
• Documented resistance or inadequate response to first-line therapies, such as Phosphodiesterase type 5 inhibitors (PDE5i).
• IIEF-5 (International Index of Erectile Function) score < 21 at baseline.
• Stable relationship with a partner for the duration of the study.
• Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria

• Psychogenic erectile dysfunction (not related to organic causes).
• Anatomical deformities of the penis (e.g., Peyronie's disease, severe penile curvature, or fibrosis that prevents injection).
• Uncontrolled systemic diseases, including decompensated diabetes mellitus (HbA1c > 9%), severe cardiovascular disease, or uncontrolled hypertension.
• History of pelvic malignancy (e.g., prostate or bladder cancer) or undergoing active radiation/chemotherapy.
• Active infection (local or systemic) or skin diseases at the site of the intended injection.
• Hematological disorders, such as severe anemia, coagulopathy, thrombocytopenia, or current use of anticoagulants that cannot be safely paused.
• Testosterone deficiency (Hypogonadism) that has not been stabilized by hormone replacement therapy.
• History of drug or alcohol abuse that may interfere with study compliance.
• Participation in another clinical trial involving experimental treatments for erectile dysfunction within the last 3 months.

The IPD share plan is not completed yet.