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

Prospective Observational Study on Intracavernosal Injection of Autologous Adipose Tissue-Derived Stem Cells (ADSC) or Stem Cell-derived Exosomes for the Treatment of Erectile Dysfunction

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.

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
• Intervention / Treatment: Procedure: Autologous Adipose Tissue-Derived Stem Cell Injection for Erectile Dysfunction; Procedure: Stem cell-derived Exosomes Injection for Erectile Dysfunction

Detailed Description

Detailed Description:

This prospective observational study is designed to evaluate the safety and preliminary efficacy of intracavernosal injections of autologous adipose tissue-derived stem cells (ADSCs) or stem cell-derived exosomes for treating erectile dysfunction (ED) in men unresponsive to conventional therapies, such as phosphodiesterase type 5 (PDE-5) inhibitors. The primary focus will be on improvements in erectile function, as measured by changes in the International Index of Erectile Function (IIEF) score. Additionally, the study will assess penile hemodynamics, monitor adverse events, and explore biomarkers that may predict therapeutic outcomes.

Background and Rationale:

Erectile dysfunction affects a significant proportion of the male population, particularly with advancing age, and can result from various causes, including vascular, neurogenic, and psychogenic factors. Current standard treatments, such as PDE-5 inhibitors, are effective for many, but a substantial subset of patients-especially those with underlying vascular or nerve-related pathologies-experience inadequate therapeutic responses.

Regenerative medicine has emerged as a promising approach for addressing ED through tissue repair and vascular regeneration. Both ADSCs and stem cell-derived exosomes are potential therapies due to their ability to promote angiogenesis, tissue regeneration, and anti-inflammatory effects. ADSCs can be harvested from the patient's adipose tissue, minimizing the risk of immunogenicity or rejection. Exosomes derived from stem cells, on the other hand, offer a cell-free approach, delivering growth factors and signaling molecules to the target tissues. Preclinical studies have demonstrated the potential of these therapies to restore erectile function through tissue remodeling and enhanced penile blood flow following intracavernosal injection.

Primary Objective:

To evaluate the safety and efficacy of intracavernosal ADSC or stem cell-derived exosome injections in improving erectile function, as determined by changes in the IIEF score from baseline through subsequent follow-ups. The IIEF is a validated, comprehensive questionnaire used to assess erectile function and sexual satisfaction.

Secondary Objectives:

Penile Hemodynamics: Doppler ultrasound will evaluate changes in penile blood flow post-treatment, providing insight into the vascular effects of the therapies.

Long-Term Effects: Follow-up visits at 3, 6, 9, and 12 months will include IIEF scoring, Doppler ultrasound assessments, and patient-reported outcomes to evaluate the durability of treatment effects.

Safety and Adverse Events: All potential adverse events, including injection-site reactions and systemic complications, will be closely monitored and documented throughout the study.

Biomarker Exploration: Exploratory analyses will aim to identify biomarkers, including vascular and tissue-specific markers, which may predict patient response to the treatment.

Study Design:

This open-label, single-arm, pilot observational study will serve as a preliminary investigation of ADSC or stem cell-derived exosome therapy in ED, providing foundational data on their feasibility and safety. As a prospective observational study, the emphasis will be on safety and gathering initial efficacy data rather than delivering definitive conclusions.

Study Population:

The study will enroll 30 men aged 30 to 75 years with a diagnosis of mild to moderate erectile dysfunction who have failed or experienced suboptimal responses to PDE-5 inhibitors. Participants will be recruited from Dr. Ranjith Ramasamy's clinic, where they are receiving care for ED. Inclusion and exclusion criteria have been carefully designed to select participants who are most likely to benefit from these therapies and ensure patient safety.

Sample Size Rationale:

A sample size of 30 was chosen based on the exploratory nature of the study. The primary goal is to assess feasibility, safety, and preliminary efficacy while providing sufficient data to inform the design of future, more extensive studies. Recruitment of 30 participants is feasible within the clinic's patient population over the planned two-year period.

Study Procedures:

Informed Consent: Participants will be fully informed about the study, including its risks and benefits, and will provide written consent prior to enrollment.

Baseline Assessments: Baseline data, including IIEF scores, penile Doppler ultrasound, and blood tests, will be collected to assess pre-treatment erectile function and overall health.

Therapeutic Administration:

For ADSCs: ADSCs will be isolated from autologous adipose tissue harvested via minimally invasive liposuction. The cells will be processed and prepared for direct injection into the corpus cavernosum. A tourniquet will be placed for 15 minutes around the base of the penis after the injection to minimize systemic dispersion.

For Exosomes: Exosomes derived from stem cells will be isolated and purified, then injected intracavernosally using a similar protocol.

Follow-Up Monitoring: Participants will be monitored for immediate post-injection reactions and at regular intervals (3, 6, 9, and 12 months) for changes in erectile function (IIEF), penile hemodynamics (Doppler ultrasound), and adverse events. Exploratory biomarker analysis will also be conducted.

Data Collection and Analysis:

Data will be analyzed to evaluate primary and secondary outcomes. IIEF score changes will be the primary efficacy measure, while penile hemodynamics and adverse event rates will be assessed for safety. Exploratory analyses will investigate the correlation between biomarkers and clinical outcomes, providing insights into potential predictors of treatment response.

Ethical Considerations:

This study will adhere to ethical standards for clinical research. Informed consent will be obtained from all participants, and the protocol will be reviewed and approved by an ethics committee. Participants will have the right to withdraw at any point, and their standard medical care will not be affected by their participation.

Expected Outcomes:

The study aims to provide early evidence on the safety and potential efficacy of ADSC or stem cell-derived exosome therapy for ED. If successful, participants are expected to show improvements in erectile function with minimal adverse events. The findings from this study will inform larger, more definitive trials and contribute to the development of novel regenerative therapies for erectile dysfunction.

• Study Type: Observational
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ranjith Ramasamy, MD; Phone Number: +971 800 522823; Email: ranjith.ramasamy@jac.ae
• Study Contact Backup: Name: Jessie Bagolor, RN; Email: jessie.bagolor@jac.ae

Study Locations

• United Arab Emirates
  • Dubai
    • Dubai, Dubai, United Arab Emirates
      • Recruiting
      • Jumeirah American Clinic
      • Contact: Ranjith Ramasamy, MD; Phone Number: +971 800 522823; Email: ranjith.ramasamy@jac.ae
      • Contact: Jessie Magoncia Bagolor, RN; Phone Number: +971 50 869 8497; Email: jessie.bagolor@jac.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: ADSC Injection for ED; Fat-Derived Stem Cell Therapy for Erectile Dysfunction; Autologous Fat Stem Cell Injection
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; 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.; Other Names: Extracellular Vesicle Therapy; Cell-Free Regenerative Therapy for ED

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penile Hemodynamics as Measured by Doppler Ultrasound	The secondary outcome measure for this study is penile hemodynamics assessed by Doppler ultrasound. Doppler ultrasound is a non-invasive imaging technique used to evaluate blood flow and vascular function in the penis. This assessment will be conducted at baseline and during follow-up visits to determine changes in penile blood flow and vascular characteristics following the intracavernosal injection of autologous adipose tissue-derived stem cells. Improvements in penile hemodynamics, such as increased blood flow and better vascular function, will be used to gauge the effectiveness of the stem cell therapy in enhancing erectile function. This measure will complement changes in the International Index of Erectile Function (IIEF) score and provide a detailed understanding of the physiological effects of the treatment.	12 months

Collaborators and Investigators

• Sponsor: Jumeirah American Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: stem cell therapy; Exosomes; Erectile dysfunction (ED); Autologous adipose tissue-derived stem cells (ADSC); Regenerative medicine for ED
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Demographic Information: Age, gender, and relevant medical history. Baseline Assessments: Initial International Index of Erectile Function (IIEF) scores, Doppler ultrasound measurements, and other relevant baseline data.

Treatment Data: Details of the autologous adipose tissue-derived stem cell injections, including dosage and administration specifics.

Follow-Up Data: Changes in IIEF scores and Doppler ultrasound measurements at follow-up points (3, 6, 9, and 12 months).

Adverse Events: Documentation of any adverse events or complications experienced during the study.

• IPD Sharing Time Frame: January 1, 2025 to December 31, 2027

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No