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.

Timeline

Start

2024-09-09

Primary completion

2026-01-31

Completion

2026-11-01

Publications

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

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