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

April 15, 2026 updated by: National Scientific Medical Center, Kazakhstan

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • National Scientific Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous Bone Marrow 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.
Biological: 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.
Experimental: Autologous 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.
Biological: 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.
Active Comparator: Standard Care plus Shock Wave Therapy (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 .
Device: 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
Experimental: Autologous Platelet-Rich Plasma (PRP) 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).
Biological: 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.
Experimental: Autologous Platelet-Rich Plasma (PRP) 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).
Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, 3 months, 6 months, 9 months and 12 months post-treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Erectile Hardness Score (EHS)
Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months post-treatment.
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).
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.
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.
Baseline and 3 months post-treatment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: Throughout the study period (up to 6 months).
Monitoring and recording of all local and systemic adverse events, including pain at the injection site, hematoma, infection, or any allergic reactions related to the intracavernosal administration of BMSC, ADSC or PRP.
Throughout the study period (up to 6 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Scientific Medical Center, Kazakhstan

Collaborators

Medical Center Medi-Art

Investigators

  • Principal Investigator: Manarbek Askarov, PhD, National Scientific Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2024

Primary Completion (Actual)

January 31, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP23488303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The IPD share plan is not completed yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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