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

NCT07544537 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: AP23488303
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Erectile Dysfunction

Keywords

erectile dysfunction; regenerative medicine; mesenchymal stem cells; platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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

  Baseline and 3 months post-treatment.

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  Throughout the study period (up to 6 months).

Study Arms (5)

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.

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.

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 .

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).

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).

Biological: Autologous Platelet-Rich Plasma (6 mL)

Interventions

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 Bone Marrow Mesenchymal Stem Cells (BMSC)

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 (PRP) 4 mL

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

Autologous Platelet-Rich Plasma (PRP) 6 mL

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.

Autologous Adipose Tissue Mesenchymal Stromal Cells (ADSC)

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

Standard Care plus Shock Wave Therapy (SWT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Scientific Medical Center, Kazakhstan: lead
• Medical Center Medi-Art: collaborator

Study Sites (1)

National Scientific Medical Center

Astana, 010000, Kazakhstan

Location

Related Publications (8)

• 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.

  PMID: 16528082 RESULT

• Panunzio 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.

  PMID: 37993601 RESULT

• Ghavam 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.

  PMID: 40830783 RESULT

• Trigo 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.

  PMID: 38729561 RESULT

• You 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.

  PMID: 34326007 RESULT

• Bivalacqua 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.

  PMID: 11121838 RESULT

• McMahon 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.

  PMID: 31099420 RESULT

• Muneer A, Kalsi J, Nazareth I, Arya M. Erectile dysfunction. BMJ. 2014 Jan 27;348:g129. doi: 10.1136/bmj.g129. No abstract available.

  PMID: 24468580 RESULT

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Manarbek Askarov, PhD

  National Scientific Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: September 9, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

KA (1)