Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605508
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Regenerative Injection of Stem Cells for Erectile Dysfunction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase IIA Clinical Trial on Intracavernosal Injection of Autologous Adipose Tissue Derived Stem Cells ADSC for the Treatment of Erectile Dysfunction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RISE
Brief Summary:
The goal of this Phase IIA clinical trial is to evaluate whether injections of stem cells derived from the patients 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 eg 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
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
Detailed Description:
Detailed Description
This Phase IIA clinical trial is designed to evaluate the safety and preliminary efficacy of intracavernosal injections of autologous adipose tissue-derived stem cells ADSCs 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 trial 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 ADSCs are a potential therapy due to their ability to differentiate into multiple cell types promote angiogenesis and support tissue regeneration ADSCs can be harvested from the patient39s adipose tissue minimizing the risk of immunogenicity or rejection Preclinical studies have demonstrated the ability of ADSCs 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 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 be employed to evaluate changes in penile blood flow post-treatment providing insight into the vascular effects of ADSC therapy
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 trial will serve as a preliminary investigation of ADSC therapy in ED providing foundational data on its feasibility and safety As a Phase IIA 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 Ramasamy39s 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 ADSC therapy 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 clinic39s 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
Stem Cell Harvesting and Injection ADSCs will be isolated from autologous adipose tissue harvested via minimally invasive liposuction The stem cells will be processed and prepared for direct injection into the corpus cavernosum The cells will be divided into two equal volumes and injected into each corpus cavernosum A tourniquet will be placed for 15 minutes around the base of the penis after the injection to minimize the cells from traveling back into the bloodstream
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 trial aims to provide early evidence on the safety and potential efficacy of ADSC 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
This Phase IIA clinical trial is designed to evaluate the safety and preliminary efficacy of intracavernosal injections of autologous adipose tissue-derived stem cells ADSCs 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 trial 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 ADSCs are a potential therapy due to their ability to differentiate into multiple cell types promote angiogenesis and support tissue regeneration ADSCs can be harvested from the patient39s adipose tissue minimizing the risk of immunogenicity or rejection Preclinical studies have demonstrated the ability of ADSCs 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 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 be employed to evaluate changes in penile blood flow post-treatment providing insight into the vascular effects of ADSC therapy
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 trial will serve as a preliminary investigation of ADSC therapy in ED providing foundational data on its feasibility and safety As a Phase IIA 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 Ramasamy39s 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 ADSC therapy 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 clinic39s 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
Stem Cell Harvesting and Injection ADSCs will be isolated from autologous adipose tissue harvested via minimally invasive liposuction The stem cells will be processed and prepared for direct injection into the corpus cavernosum The cells will be divided into two equal volumes and injected into each corpus cavernosum A tourniquet will be placed for 15 minutes around the base of the penis after the injection to minimize the cells from traveling back into the bloodstream
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 trial aims to provide early evidence on the safety and potential efficacy of ADSC 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None