Scientific project «Evaluation of the clinical effectiveness and safety of the use of mesenchymal stem cells in organic forms of erectile dysfunction» (ИРН AP23488303)
Project goal: to evaluate the effectiveness and safety of methods of injection penile stem cell therapy for organic forms of erectile dysfunction.
Type of study: multicenter, open.
Research design: case-control study.
The study will include four groups of patients suffering from organic forms of erectile dysfunction (ED):
1) Patients with organic form of ED with intracavernous injection of mesenchymal autologous bone marrow stem cells (n=20)
2) Patients with an organic form of ED with intracavernous injection of mesenchymal autologous stromal cells of adipose tissue (n=20)
3) Patients with an organic form of ED with intracavernous administration of autologous platelet-rich plasma (n=20)
4) Patients with an organic form of ED who received conservative treatment, supplemented by a course of low-intensity radial shock wave therapy (n=20)
Patients in the study groups: Male patients aged 18 to 70 years who were diagnosed and confirmed to have an organic form of erectile dysfunction that was resistant to first-line therapy (phosphodiesterase type 5 inhibitors) and intracavernous pharmacological injections of drugs were ineffective or intolerance reactions were noted.
Exclusion criteria:
- age up to 18 years;
- disorders of the blood coagulation system;
- severe concomitant pathology (decompensated diseases of the endocrine system, decompensated forms of diabetes, severe diseases of the cardiovascular system)
- inorganic causes of erectile dysfunction (psychogenic, endocrine)
- patients with drug-induced erectile dysfunction.
- patients with penile endoprosthesis.
- patients with anatomical deformations of the penis (Peyronie's disease or congenital curvature of the penis) or a history of priapism resulting in sclerosis of the cavernous bodies).
- previous operations on the penis for erectile dysfunction, premature ejaculation
Expected results: This research work represents the first attempt in Kazakhstan to compare the effectiveness of treating organic forms of erectile dysfunction. Intracavernosal injections of mesenchymal autologous bone marrow stem cells and intracavernosal injections of mesenchymal autologous adipose tissue stromal cells and intracavernosal administration of autologous platelet-rich plasma (APOT/PRP therapy) compared with a control group of patients with an organic form of erectile dysfunction who received conservative treatment, according to the clinical protocols of the Ministry of Health of the Republic of Kazakhstan, supplemented by a course of low-intensity radial shock wave therapy.
This study will allow us to study specific and nonspecific mechanisms of action, as well as monitor the early and long-term consequences of bone marrow stem cell and adipose tissue stem cell transplants.
Project Manager: Askarov Manarbek Bapovich, Doctor of Medical Sciences, Professor, laureate of the State Prize of the Republic of Kazakhstan in the field of science and technology named after Al-Farabi for 2020, Director of the Institute of Fundamental and Applied Medicine of JSC National Scientific Medical Center
Со-Project Manager: Iskakov Erbol Amangeldinovich PhD, head of the urology department of NSMC JSC.
Project executors (members of the temporary research team):
Nugumanov Rinat Muratkhanovich PhD, urologist-andrologist.
Omarbaev Rustam Tokenovich, Master of Medicine, urologist-andrologist.
Sushchenko Alexey Fedorovich, PhD, urologist-andrologist.
Ermaganbetov Erkebulan Meshitbaevich, urologist-andrologist.
Turgunbaev Timur Nursultanovich, urologist-andrologist.
Ganina Anastasia Mikhailovna, biotechnologist
Paizullayeva Saule Nurgalievna scientific Manager
Shulga Lyudmila Mikhailovna, economist
Study period: 2024-2026
Financing: grant financing of the Science Committee of the Ministry of Science and Higher Education of the Republic of Kazakhstan
Project publications: major publications are planned for 2025-2026
In August 2024, based on the results of the literature review, an article was published in the journal International braz j urol: official journal of the Brazilian Society of Urology, indexed in the Scopus database and having the 2nd quartile and 74th percentile in the category "Surgery": Iskakov Y, Omarbayev R, Nugumanov R, Turgunbayev T, Yermaganbetov Y. Treatment of erectile dysfunction by intracavernosal administration of mesenchymal stem cells in patients with diabetes mellitus. International braz j urol: official journal of the Brazilian Society of Urology, 2024, 50(4):386-397. DOI: 10.1590/S1677-5538.IBU.2024.0100.
Based on the intermediate results of the study, a thesis was prepared: “Efficacy and safety of intracavernous administration of platelet-rich plasma in the treatment of erectile dysfunction in the Kazakh population: results of a six-month follow-up Rinat Nugumanov, Yerbol Iskakov, Rustam Omarbayev, Yerkebulan Yermaganbetov, Timur Turgunbayev, Damir Akhmetkaliyev, Alexei Suchshenko, and Abai Baigenzhin.
This thesis was presented by the cо-project Manager E.A. Iskakov at the Singapore International Symposium (Singapore, 11.12-13.12.2024).