Regenerative Injection of Stem Cells or Stem Cell-derived Exosomes for Erectile Dysfunction (RISE)

NCT06605508 | Recruiting DMC

• 1 other identifier: 001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective observational study is to evaluate whether injections of stem cells derived from the patient's own fat tissue (adipose tissue) can improve erectile function in men aged 30 to 75 who have erectile dysfunction (ED) and have not responded well to standard treatments like PDE-5 inhibitors (e.g., Viagra). The main questions the study aims to answer are: Will the stem cell injections improve erectile function, as measured by the International Index of Erectile Function (IIEF) score? Are there any changes in blood flow to the penis, which will be measured using a Doppler ultrasound? Participants will: Receive injections of their own stem cells (obtained from a biopsy of fat) directly into the penis. Undergo assessments to check erectile function before and after treatment. Have follow-up visits at 3, 6, 9, and 12 months to monitor long-term effects. The study will also look for any possible side effects or complications and evaluate biological markers in the penis that may indicate the effectiveness of the treatment. Participants will be recruited from clinic where they are already receiving care for ED. To take part, they must be in good overall health, with no severe heart disease, uncontrolled diabetes, cancer, or other conditions that could make stem cell therapy unsafe for them.

Conditions

Erectile Dysfunction; Erectile Dysfunction Associated With Type 2 Diabetes Mellitus; Erectile Dysfunction Following Radical Prostatectomy

Keywords

stem cell therapy; Erectile dysfunction (ED); Autologous adipose tissue-derived stem cells (ADSC); Regenerative medicine for ED; Exosomes

Outcome Measures

Primary Outcomes (1)

• Change in Erectile Function as Measured by the International Index of Erectile Function (IIEF) Score

  The primary outcome measure for this study is the change in erectile function as assessed by the International Index of Erectile Function (IIEF) score. The IIEF is a validated questionnaire designed to evaluate various aspects of sexual health, including erectile function, sexual satisfaction, and overall sexual performance. Participants will complete the IIEF questionnaire at baseline and at follow-up visits to track changes in erectile function over time. The goal is to determine whether the intracavernosal injection of autologous adipose tissue-derived stem cells leads to significant improvements in erectile function compared to pre-treatment levels. The IIEF score will provide a comprehensive measure of treatment effectiveness and help assess the impact of the intervention on participants\' sexual health and quality of life.

  12 months

Secondary Outcomes (1)

• Penile Hemodynamics as Measured by Doppler Ultrasound

  12 months

Study Arms (2)

Intracavernosal Injection of Autologous Adipose Stem Cells for Erectile Dysfunction Treatment

In this arm of the study, participants will receive intracavernosal injections of autologous adipose tissue-derived stem cells (ADSC). The ADSC are collected from the participant's own body fat through a minimally invasive liposuction procedure. After processing, the stem cells will be injected directly into the erectile tissue of the penis. This treatment aims to improve erectile function by stimulating tissue regeneration and enhancing blood flow. Participants will be monitored for safety and efficacy, including erectile function assessments using the International Index of Erectile Function (IIEF) and penile hemodynamics measured by Doppler ultrasound. Follow-up evaluations will occur at 3, 6, 9, and 12 months post-treatment.

Procedure: Autologous Adipose Tissue-Derived Stem Cell Injection for Erectile Dysfunction

Intracavernosal Injection of Stem cell-derived exosomes

In this arm of the study, participants will receive intracavernosal injections of stem cell-derived exosomes. These exosomes, which are nano-sized extracellular vesicles obtained from cultured stem cells, are rich in growth factors and bioactive molecules that facilitate tissue repair and regeneration. Unlike stem cell therapy, this cell-free approach minimizes potential risks associated with live cell transplantation while still delivering therapeutic benefits. Participants will be monitored for safety and efficacy, including erectile function assessments using the International Index of Erectile Function (IIEF) and penile hemodynamics measured by Doppler ultrasound. Follow-up evaluations will occur at 3, 6, 9, and 12 months post-treatment.

Procedure: Stem cell-derived Exosomes Injection for Erectile Dysfunction

Interventions

Autologous Adipose Tissue-Derived Stem Cell Injection for Erectile Dysfunction PROCEDURE

This intervention involves the use of autologous adipose tissue-derived stem cells (ADSC) to treat erectile dysfunction. The process begins with a minimally invasive liposuction procedure to harvest fat tissue from the participant\'s own body. The harvested fat is then processed to isolate stem cells, which are subsequently injected directly into the erectile tissue of the penis. This approach aims to enhance erectile function by promoting tissue regeneration and improving blood flow. Unlike other treatments for erectile dysfunction, this intervention uses stem cells derived from the participant\'s own fat, which may reduce the risk of immune rejection and offer a novel regenerative therapy option. The treatment is designed to address ED in patients who have not responded adequately to conventional therapies like PDE-5 inhibitors.

Also known as: ADSC Injection for ED, Fat-Derived Stem Cell Therapy for Erectile Dysfunction, Autologous Fat Stem Cell Injection

Intracavernosal Injection of Autologous Adipose Stem Cells for Erectile Dysfunction Treatment

Stem cell-derived Exosomes Injection for Erectile Dysfunction PROCEDURE

This intervention involves the use of stem cell-derived exosomes to treat erectile dysfunction. Exosomes are nano-sized extracellular vesicles secreted by stem cells, containing bioactive molecules such as growth factors and signaling proteins that promote tissue repair and regeneration. Unlike therapies requiring the transplantation of live cells, this cell-free approach eliminates the need for invasive harvesting procedures. The exosomes are carefully purified from cultured stem cells and prepared for direct injection into the erectile tissue of the penis. This approach aims to enhance erectile function by stimulating tissue regeneration, reducing inflammation, and improving blood flow. Unlike other treatments for erectile dysfunction, exosome therapy offers a novel regenerative option, potentially benefiting patients who have not responded adequately to conventional therapies such as PDE-5 inhibitors.

Also known as: Extracellular Vesicle Therapy, Cell-Free Regenerative Therapy for ED

Intracavernosal Injection of Stem cell-derived exosomes

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of men aged 30 to 75 years with a clinical diagnosis of mild to moderate erectile dysfunction (ED). Eligible participants are those who have experienced suboptimal or no response to standard therapies, including phosphodiesterase type 5 (PDE-5) inhibitors. The inclusion criteria are designed to focus on individuals most likely to benefit from regenerative therapy while ensuring safety. Participants will be recruited from Dr. Ranjith Ramasamy's clinic, where they are actively seeking care for erectile dysfunction. This population is expected to represent a diverse group of patients with varying etiologies of ED, including vascular, neurogenic, and idiopathic causes.

You may qualify if:

• Age: Adult males aged 30 to 75 years.
• Diagnosis: Confirmed diagnosis of erectile dysfunction (ED) of mild to moderate severity, as defined by an International Index of Erectile Function (IIEF) score.
• Treatment Response: Failure or suboptimal response to conventional ED treatments, such as PDE-5 inhibitors.
• General Health: Overall good health without contraindications to stem cell therapy.
• Informed Consent: Ability and willingness to provide written informed consent to participate in the study.

You may not qualify if:

• Severe Cardiovascular Disease: Presence of severe cardiovascular conditions, including uncontrolled hypertension or significant heart disease.
• Active Infections: Ongoing infections that could interfere with treatment or pose a risk to the participant.
• Malignancies: History of or current cancer, including malignancies that could affect safety or treatment outcomes.
• Contraindications to Stem Cell Therapy: Any medical conditions or treatments that contraindicate the use of stem cell therapy.
• Uncontrolled Diabetes: Poorly controlled diabetes or other metabolic disorders that could impact treatment efficacy or safety.
• Psychiatric or Cognitive Impairments: Significant psychiatric or cognitive disorders that may affect the participant\'s ability to comply with study protocols or provide informed consent.
• Recent Surgery or Trauma: Recent major surgeries or physical trauma that could impact the study or interfere with the intervention.
• Participation in Other Studies: Participation in other clinical trials or studies that may affect the outcomes or safety of this study.

Sponsors & Collaborators

• Jumeirah American Clinic: lead

Study Sites (1)

Jumeirah American Clinic

Dubai, Dubai, United Arab Emirates

RECRUITING

Related Publications (1)

• Narasimman M, Sandler M, Bernstein A, Loloi J, Saltzman RG, Bernie H, Ramasamy R. A primer on the restorative therapies for erectile dysfunction: a narrative review. Sex Med Rev. 2024 Jun 26;12(3):505-512. doi: 10.1093/sxmrev/qeae012.

  PMID: 38494449 BACKGROUND

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

Central Study Contacts

Ranjith Ramasamy, MD

CONTACT

+971 800 522823; ranjith.ramasamy@jac.ae

Jessie Bagolor, RN

CONTACT

jessie.bagolor@jac.ae

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Urologist

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: January 1, 2025 to December 31, 2027
• Access Criteria: Access to individual participant data (IPD) and supporting information from this study will be managed according to the following criteria: Eligible Users: Access will be granted to qualified researchers, academic institutions, and regulatory bodies who have a legitimate interest in the data, such as those conducting further analyses or validating study findings. Data Access: Research Data: Includes de-identified demographic information, baseline assessments, treatment data, follow-up results, adverse event reports, and biomarker data. Supporting Information: Includes study protocols, informed consent forms, and other relevant documentation. Access Process: Request Submission: Interested parties must submit a formal request detailing the purpose of data use and how the data will be used. Review and Approval: Requests will be reviewed by the study\'s data access committee or a designated review board to ensure they meet ethical and scientific standards.

Locations

AE (1)