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

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

Interventions

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.

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.

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

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.

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

Sponsors & Collaborators

• Medical Center Medi-Art

  collaborator UNKNOWN

• National Scientific Medical Center, Kazakhstan

  lead OTHER_GOV

Principal Investigators

• Manarbek Askarov, PhD · National Scientific Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-09

Primary Completion

2026-01-31

Completion

2026-11-01

Countries

• Kazakhstan

Study Locations