Erectile DysfunctionPhase 2NCT07544537
A Prospective Comparative Study of Autologous Bone Marrow-Derived and Adipose Tissue-Derived Mesenchymal Stem Cells Versus Platelet-Rich Plasma and Standard Therapy in Patients With Organic Erectile Dysfunction
A Phase 2 study testing Autologous Bone marrow-derived Mesenchymal Stem Cells (BMSC), Autologous Platelet-Rich Plasma (4 mL) and Autologous Platelet-Rich Plasma (6 mL) in people with Erectile Dysfunction, run by National Scientific Medical Center, Kazakhstan at 1 site in Kazakhstan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Autologous Bone marrow-derived Mesenchymal Stem Cells (BMSC), Autologous Platelet-Rich Plasma (4 mL) and Autologous Platelet-Rich Plasma (6 mL)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKazakhstan
- Study dates
- 9 Sep 2024to 1 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Erectile Dysfunction
- Being tested
- Autologous Bone marrow-derived Mesenchymal Stem Cells (BMSC), Autologous Platelet-Rich Plasma (4 mL), Autologous Platelet-Rich Plasma (6 mL), Adipose Tissue Mesenchymal Stromal Cells (ADSC), Low-intensity radial shock wave therapy (Li-SWT)
- Keywords
- erectile dysfunction, regenerative medicine, mesenchymal stem cells, platelet-rich plasma
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Bone marrow-derived Mesenchymal Stem Cells (BMSC)Biological
A single dose of autologous bone marrow-derived mesenchymal stem cells (≥1.7 × 10⁷ cells) administered via intracavernosal injection. The intervention begins with the harvesting of approximately 27 mL of bone marrow from the patient. This concentrate is processed to a final volume of 4-6 mL for injection into the corpora cavernosa. The procedure is performed under ultrasound guidance with a penile clamp applied 5 minutes before and maintained for 15 minutes after injection to maximize cell retention.
Autologous Platelet-Rich Plasma (4 mL)Biological
Three sessions of intracavernosal injections of 4 mL autologous platelet-rich plasma at 3-week intervals. The PRP is prepared from 22 mL of the patient's venous blood mixed with 1.2 mL of citrate-phosphate-dextrose (CPD) and centrifuged for 20 minutes at 2000 rpm. The final product achieves a platelet concentration of ≥ 1 million/µL (total count of 4000 × 10⁶ platelets). A penile clamp is applied for 20 minutes post-injection to enhance tissue retention.
Autologous Platelet-Rich Plasma (6 mL)Biological
Three sessions of intracavernosal injections of 6 mL autologous platelet-rich plasma at 3-week intervals. The PRP is prepared from 33 mL of venous blood with 1.8 mL of CPD, centrifuged for 20 minutes at 2000 rpm. The final product achieves a platelet concentration of ≥ 1 million/µL (total count of 6000 × 10⁶ platelets). A penile clamp is used for 20 minutes post-injection to facilitate local absorption
Adipose Tissue Mesenchymal Stromal Cells (ADSC)Biological
A single intracavernosal injection of at least 25 x 10⁶ autologous adipose tissue-derived stromal cells. The process involves lipoaspiration of 50 mL of water-fat suspension material, which is processed into a total volume of 4 mL for administration into the cavernous bodies.
Low-intensity radial shock wave therapy (Li-SWT)Device
Standard conservative treatment according to national clinical protocols, supplemented by a course of 6 sessions of low-intensity radial shock wave therapy (Li-SWT). Therapy is delivered twice per week, consisting of 2500 shocks per session distributed across five zones of the corpora cavernosa
| Study group | Role | What they receive |
|---|---|---|
| Autologous Bone Marrow Mesenchymal Stem Cells (BMSC) | Experimental | Patients receive a single intracavernosal injection of autologous bone marrow mesenchymal stem cells at a concentration of approximately 1.7 × 10⁸ cells. The intervention involves the auto-collection of 27 ml of bone marrow, which is processed and separated into a 4 ml volume for introduction into the tissue of the cavernous bodies. Receives: Biological: Autologous Bone marrow-derived Mesenchymal Stem Cells (BMSC) |
| Autologous Adipose Tissue Mesenchymal Stromal Cells (ADSC) | Experimental | Patients receive a single intracavernosal injection of at least 25 x 10⁶ autologous adipose tissue-derived stromal cells. These cells are obtained via lipoaspiration of 50 ml of water-fat suspension material and processed into a total volume of 4 ml for injection. Receives: Biological: Adipose Tissue Mesenchymal Stromal Cells (ADSC) |
| Standard Care plus Shock Wave Therapy (SWT) | Active comparator | Patients receive standard conservative treatment according to Ministry of Health clinical protocols, supplemented by a course of low-intensity radial shock wave therapy (SWT). The course includes 6 total sessions (2 sessions per week), with 2500 shocks delivered to 5 zones of the corpora cavernosa per session . Receives: Device: Low-intensity radial shock wave therapy (Li-SWT) |
| Autologous Platelet-Rich Plasma (PRP) 4 mL | Experimental | Patients receive three intracavernosal injection sessions of 4 mL of autologous platelet-rich plasma (PRP) at 3-week intervals. The PRP is prepared from 22 mL of venous blood with 1.2 mL of citrate-phosphate-dextrose (CPD) added, centrifuged to achieve a platelet concentration of ≥ 1 million/µL (total platelet count of 4000 × 10⁶). Receives: Biological: Autologous Platelet-Rich Plasma (4 mL) |
| Autologous Platelet-Rich Plasma (PRP) 6 mL | Experimental | Patients receive three intracavernosal injection sessions of 6 mL of autologous platelet-rich plasma (PRP) at 3-week intervals. The PRP is prepared from 33 mL of venous blood with 1.8 mL of citrate-phosphate-dextrose (CPD) added, centrifuged to achieve a platelet concentration of ≥ 1 million/µL (total platelet count of 6000 × 10⁶). Receives: Biological: Autologous Platelet-Rich Plasma (6 mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in International Index of Erectile Function (IIEF-5) Score
The IIEF-5 is a validated 5-item multidimensional scale used to assess the presence and severity of erectile dysfunction. Scores range from 5 to 25, with higher scores indicating better erectile function. Success is defined as a significant increase in the score compared to baseline.
Measured: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months post-treatment.
Secondary outcomes (2)
Change from Baseline in Erectile Hardness Score (EHS)
The EHS is a 4-point scale used to assess the rigidity of the erection (1: Penis is larger but not hard; 2: Penis is hard but not hard enough for penetration; 3: Penis is hard enough for penetration but not completely hard; 4: Penis is completely hard and fully rigid).
Measured: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months post-treatment.
Change from Baseline in Peak Systolic Velocity (PSV) via Penile Doppler Ultrasound
Measured using Pharmacological Color Doppler Ultrasonography (PCDU). This objective measure assesses the blood inflow to the cavernous arteries. An increase in PSV (measured in cm/sec) indicates improved arterial flow.
Measured: Baseline and 3 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start9 Sep 2024
- Primary completion31 Jan 2026
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Scientific Medical Center, Kazakhstan
- Sponsor type
- Other government
- Collaborators
- Medical Center Medi-Art
- Responsible party
- Sponsor
- Investigators
- Manarbek Askarov, PhD, Principal investigator, National Scientific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544537
- Sponsor's protocol ID
- AP23488303
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD share plan is not completed yet.
Publications
McMahon CN, Smith CJ, Shabsigh R. Treating erectile dysfunction when PDE5 inhibitors fail. BMJ. 2006 Mar 11;332(7541):589-92. doi: 10.1136/bmj.332.7541.589. No abstract available.
PubMed 16528082Panunzio A, Labate C, Zacheo F, Orlando R, Rizzo FL, Porcaro AB, Migliorini F, Pagliarulo V, Tafuri A. Platelet-rich plasma intracavernosal injections for the treatment of primary organic erectile dysfunction: a systematic review and meta-analysis of contemporary controlled studies. Int J Impot Res. 2024 Sep;36(6):562-571. doi: 10.1038/s41443-023-00798-y. Epub 2023 Nov 22.
PubMed 37993601Ghavam A, Sheikhnia F, Heidari MM, Valilo M, Mahmoudnejad Z, Gur S. An updated narrative review on revolutionizing erectile dysfunction treatment: the crucial role of trophic factors in Adipose-Derived stem cell therapy. BMC Urol. 2025 Aug 19;25(1):206. doi: 10.1186/s12894-025-01861-0.
PubMed 40830783Trigo CM, Rodrigues JS, Camoes SP, Sola S, Miranda JP. Mesenchymal stem cell secretome for regenerative medicine: Where do we stand? J Adv Res. 2025 Apr;70:103-124. doi: 10.1016/j.jare.2024.05.004. Epub 2024 May 9.
PubMed 38729561You D, Jang MJ, Song G, Shin HC, Suh N, Kim YM, Ahn TY, Kim CS. Safety of autologous bone marrow-derived mesenchymal stem cells in erectile dysfunction: an open-label phase 1 clinical trial. Cytotherapy. 2021 Oct;23(10):931-938. doi: 10.1016/j.jcyt.2021.06.001. Epub 2021 Jul 27.
PubMed 34326007Bivalacqua TJ, Champion HC, Hellstrom WJ, Kadowitz PJ. Pharmacotherapy for erectile dysfunction. Trends Pharmacol Sci. 2000 Dec;21(12):484-9. doi: 10.1016/s0165-6147(00)01587-x.
PubMed 11121838McMahon CG. Current diagnosis and management of erectile dysfunction. Med J Aust. 2019 Jun;210(10):469-476. doi: 10.5694/mja2.50167. Epub 2019 May 17.
PubMed 31099420Muneer A, Kalsi J, Nazareth I, Arya M. Erectile dysfunction. BMJ. 2014 Jan 27;348:g129. doi: 10.1136/bmj.g129. No abstract available.
PubMed 24468580
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study of Autologous Bone Marrow-Derived and Adipose Tissue-Derived Mesenchymal Stem Cells Versus Platelet-Rich Plasma and Standard Therapy in Patients With Organic Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT07544537
- Acronym / sponsor ID
- AP23488303
- Conditions
- Erectile Dysfunction
- Keywords
- erectile dysfunction, regenerative medicine, mesenchymal stem cells, platelet-rich plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Scientific Medical Center, KazakhstanOther government
- Collaborators
- Medical Center Medi-Art
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Autologous Bone Marrow Mesenchymal Stem Cells (BMSC) | Experimental | Biological: Autologous Bone marrow-derived Mesenchymal Stem Cells (BMSC)Patients receive a single intracavernosal injection of autologous bone marrow mesenchymal stem cells at a concentration of approximately 1.7 × 10⁸ cells. The intervention involves the auto-collection of 27 ml of bone marrow, which is processed and separated into a 4 ml volume for introduction into the tissue of the cavernous bodies. |
| Autologous Adipose Tissue Mesenchymal Stromal Cells (ADSC) | Experimental | Biological: Adipose Tissue Mesenchymal Stromal Cells (ADSC)Patients receive a single intracavernosal injection of at least 25 x 10⁶ autologous adipose tissue-derived stromal cells. These cells are obtained via lipoaspiration of 50 ml of water-fat suspension material and processed into a total volume of 4 ml for injection. |
| Standard Care plus Shock Wave Therapy (SWT) | Active comparator | Device: Low-intensity radial shock wave therapy (Li-SWT)Patients receive standard conservative treatment according to Ministry of Health clinical protocols, supplemented by a course of low-intensity radial shock wave therapy (SWT). The course includes 6 total sessions (2 sessions per week), with 2500 shocks delivered to 5 zones of the corpora cavernosa per session . |
| Autologous Platelet-Rich Plasma (PRP) 4 mL | Experimental | Biological: Autologous Platelet-Rich Plasma (4 mL)Patients receive three intracavernosal injection sessions of 4 mL of autologous platelet-rich plasma (PRP) at 3-week intervals. The PRP is prepared from 22 mL of venous blood with 1.2 mL of citrate-phosphate-dextrose (CPD) added, centrifuged to achieve a platelet concentration of ≥ 1 million/µL (total platelet count of 4000 × 10⁶). |
| Autologous Platelet-Rich Plasma (PRP) 6 mL | Experimental | Biological: Autologous Platelet-Rich Plasma (6 mL)Patients receive three intracavernosal injection sessions of 6 mL of autologous platelet-rich plasma (PRP) at 3-week intervals. The PRP is prepared from 33 mL of venous blood with 1.8 mL of citrate-phosphate-dextrose (CPD) added, centrifuged to achieve a platelet concentration of ≥ 1 million/µL (total platelet count of 6000 × 10⁶). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Bone marrow-derived Mesenchymal Stem Cells (BMSC)A single dose of autologous bone marrow-derived mesenchymal stem cells (≥1.7 × 10⁷ cells) administered via intracavernosal injection. The intervention begins with the harvesting of approximately 27 mL of bone marrow from the patient. This concentrate is processed to a final volume of 4-6 mL for injection into the corpora cavernosa. The procedure is performed under ultrasound guidance with a penile clamp applied 5 minutes before and maintained for 15 minutes after injection to maximize cell retention. | Biological | Autologous Bone Marrow Mesenchymal Stem Cells (BMSC) |
| Autologous Platelet-Rich Plasma (4 mL)Three sessions of intracavernosal injections of 4 mL autologous platelet-rich plasma at 3-week intervals. The PRP is prepared from 22 mL of the patient's venous blood mixed with 1.2 mL of citrate-phosphate-dextrose (CPD) and centrifuged for 20 minutes at 2000 rpm. The final product achieves a platelet concentration of ≥ 1 million/µL (total count of 4000 × 10⁶ platelets). A penile clamp is applied for 20 minutes post-injection to enhance tissue retention. | Biological | Autologous Platelet-Rich Plasma (PRP) 4 mL |
| Autologous Platelet-Rich Plasma (6 mL)Three sessions of intracavernosal injections of 6 mL autologous platelet-rich plasma at 3-week intervals. The PRP is prepared from 33 mL of venous blood with 1.8 mL of CPD, centrifuged for 20 minutes at 2000 rpm. The final product achieves a platelet concentration of ≥ 1 million/µL (total count of 6000 × 10⁶ platelets). A penile clamp is used for 20 minutes post-injection to facilitate local absorption | Biological | Autologous Platelet-Rich Plasma (PRP) 6 mL |
| Adipose Tissue Mesenchymal Stromal Cells (ADSC)A single intracavernosal injection of at least 25 x 10⁶ autologous adipose tissue-derived stromal cells. The process involves lipoaspiration of 50 mL of water-fat suspension material, which is processed into a total volume of 4 mL for administration into the cavernous bodies. | Biological | Autologous Adipose Tissue Mesenchymal Stromal Cells (ADSC) |
| Low-intensity radial shock wave therapy (Li-SWT)Standard conservative treatment according to national clinical protocols, supplemented by a course of 6 sessions of low-intensity radial shock wave therapy (Li-SWT). Therapy is delivered twice per week, consisting of 2500 shocks per session distributed across five zones of the corpora cavernosa | Device | Standard Care plus Shock Wave Therapy (SWT) |
Primary outcome
Change from Baseline in International Index of Erectile Function (IIEF-5) Score
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months post-treatment.
The IIEF-5 is a validated 5-item multidimensional scale used to assess the presence and severity of erectile dysfunction. Scores range from 5 to 25, with higher scores indicating better erectile function. Success is defined as a significant increase in the score compared to baseline.
2 secondary outcomes
Change from Baseline in Erectile Hardness Score (EHS)
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months post-treatment.
Change from Baseline in Peak Systolic Velocity (PSV) via Penile Doppler Ultrasound
Time frame: Baseline and 3 months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 16528082McMahon CN, Smith CJ, Shabsigh R. Treating erectile dysfunction when PDE5 inhibitors fail. BMJ. 2006 Mar 11;332(7541):589-92. doi: 10.1136/bmj.332.7541.589. No abstract available.
- Results publication: PubMed 37993601Panunzio A, Labate C, Zacheo F, Orlando R, Rizzo FL, Porcaro AB, Migliorini F, Pagliarulo V, Tafuri A. Platelet-rich plasma intracavernosal injections for the treatment of primary organic erectile dysfunction: a systematic review and meta-analysis of contemporary controlled studies. Int J Impot Res. 2024 Sep;36(6):562-571. doi: 10.1038/s41443-023-00798-y. Epub 2023 Nov 22.
- Results publication: PubMed 40830783Ghavam A, Sheikhnia F, Heidari MM, Valilo M, Mahmoudnejad Z, Gur S. An updated narrative review on revolutionizing erectile dysfunction treatment: the crucial role of trophic factors in Adipose-Derived stem cell therapy. BMC Urol. 2025 Aug 19;25(1):206. doi: 10.1186/s12894-025-01861-0.
- Results publication: PubMed 38729561Trigo CM, Rodrigues JS, Camoes SP, Sola S, Miranda JP. Mesenchymal stem cell secretome for regenerative medicine: Where do we stand? J Adv Res. 2025 Apr;70:103-124. doi: 10.1016/j.jare.2024.05.004. Epub 2024 May 9.
- Results publication: PubMed 34326007You D, Jang MJ, Song G, Shin HC, Suh N, Kim YM, Ahn TY, Kim CS. Safety of autologous bone marrow-derived mesenchymal stem cells in erectile dysfunction: an open-label phase 1 clinical trial. Cytotherapy. 2021 Oct;23(10):931-938. doi: 10.1016/j.jcyt.2021.06.001. Epub 2021 Jul 27.
- Results publication: PubMed 11121838Bivalacqua TJ, Champion HC, Hellstrom WJ, Kadowitz PJ. Pharmacotherapy for erectile dysfunction. Trends Pharmacol Sci. 2000 Dec;21(12):484-9. doi: 10.1016/s0165-6147(00)01587-x.
- Results publication: PubMed 31099420McMahon CG. Current diagnosis and management of erectile dysfunction. Med J Aust. 2019 Jun;210(10):469-476. doi: 10.5694/mja2.50167. Epub 2019 May 17.
- Results publication: PubMed 24468580Muneer A, Kalsi J, Nazareth I, Arya M. Erectile dysfunction. BMJ. 2014 Jan 27;348:g129. doi: 10.1136/bmj.g129. No abstract available.
- Individual participant dataSharing planned: Undecided. The IPD share plan is not completed yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manarbek Askarov, PhD principal investigator
National Scientific Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Bone marrow-derived Mesenchymal Stem Cells (BMSC), Autologous Platelet-Rich Plasma (4 mL) and Autologous Platelet-Rich Plasma (6 mL) in people with Erectile Dysfunction, run by National Scientific Medical Center, Kazakhstan at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in International Index of Erectile Function (IIEF-5) Score (time frame: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07544537, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.