A Prospective Comparative Study of Autologous Bone Marrow-Derived and Adipose Tissue-Derived Mese… (NCT07544537) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
Kazakhstan100 participantsStarted 2024-09-09
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 inv…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in International Index of Erectile Function (IIEF-5) Score